YT YouTube2Text

YouTube2Text → Transcripts → Hearing on "Examining the Implementation of the Tobacco Control Act"

Hearing on "Examining the Implementation of the Tobacco Control Act" — Transcript

by Energy & Commerce Democrats · 15,377 words · 2,334 segments · language en · Watch on YouTube

Open in transcriber Summarize with AI Download SRT/VTT

Full transcript

0:02the subcommittee will come to
0:04order chair will recognize himself for
0:07not make
0:08statement the Tobacco Control Act TCA
0:12was signed into law on June 22nd 20
0:16209 the TCA established the center for
0:19tobacco products the
0:22CP within FDA and gave FDA authority
0:25over the regulation of tobacco products
0:28including restricting their sale
0:30distribution advertising and promotion
0:33in addition FDA has the authority to
0:36require changes in the design and
0:38characteristics of current and future
0:40tobacco products such as the reduction
0:43or elimination of harmful ingredients
0:46and additives the sole funding source
0:50for CTP is user fees assessed on Tobacco
0:55manufacturers and importers Jo has
0:58conducted a comprehensive study on the
1:00laws implementation and in September
1:032013 it released a report entitled new
1:07tobacco products FDA needs to set time
1:10frames for its review process in quote
1:14the report examines
1:16cp's review of new tobacco product
1:20submissions responses to meeting
1:22requests and use of its user fees among
1:27its findings GAO reports that CDP lacks
1:31basic performance measures quote like
1:34time frames for reviews of submissions
1:38in quote and that this quote limits
1:43cdp's ability to evaluate policies
1:46procedures and Staffing Resources in
1:48relation to CTP submission review
1:51process and in turn limits
1:55ctps ability to reasonably assure
1:58efficient operations and effective
2:00results end quote Jo concludes that
2:05quote an entity that is limited in its
2:08ability to evaluate its performance will
2:10be hard pressed to determine what
2:12adjustments it should make to its
2:15operations or how to plan for the future
2:18end quote this report raises troubling
2:21concerns about ctps performance and its
2:25ability to effectively implement the
2:27Tobacco Control Act and respond to the
2:30thousands of new product submissions it
2:32has received in a timely manner as the
2:35subcommittee with oversight of FDA and
2:37the center for tobacco products we were
2:40hoping to hear directly from the FDA
2:43however Dr Marsha Cross of GAO is here
2:46today to walk us through the report and
2:50gao's ongoing efforts to oversee
2:53implementation of the ACT yield the
2:56balance of my time to the gentleman from
2:58Kentucky Mr Guth thank you Mr chairman
3:00thank you for yielding and holding this
3:01hearing today Congress granted the
3:04center for tobacco products the
3:05authority to regulate tobacco products
3:07but unfortunately the process has been
3:09frought with problems I have heard from
3:11many in the industry including
3:12constituents who have been stuck in the
3:14dysfunctional CTP approval process as a
3:18result of ctps in action many reduced
3:21risk or harm reduction products are not
3:23being approved and are not available to
3:26Consumers there are examples of
3:27ingredients that could be potentially
3:29ardous and are removed from products
3:31sold in other International markets but
3:34because of the burdensome process at the
3:36FDA and the unlikelihood that their
3:38submission would even be reviewed they
3:40have to leave the ingredient in their
3:42product sold in the US so consumers
3:45overseas are offered a potentially less
3:47harmful product than American consumers
3:50have access to there are a number of
3:52examples like this very minor tweaks
3:55that require substantial equivalent or
3:57SE submissions and they just sit at CTP
4:00waiting approval from March 2011 until
4:02June 2013 CTP did not rule on one single
4:06filing and at that point they ruled on
4:09six of near four of nearly 4,000
4:12submissions to date I believe they have
4:15made only 12 determinations it appears
4:17the CTP is just not doing their job have
4:21a bill house resolution 389 that would
4:23exercise oversight over CTP and require
4:26they submit a report to Congress on
4:28their activity it is a good government
4:30Common Sense approach to ensure that
4:32this agency of government works and is
4:34accountable to Congress and the
4:35committee that is vested with its
4:38Authority tobacco user fees are not
4:40subject to reauthorization so there's
4:42little opportunity for the industry to
4:44enter in discussions with FDA the way
4:46pharmaceutical companies or device
4:47manufacturers can as the oversight body
4:50I believe we should be able to see how
4:52these funds are being used the number of
4:54applications being reviewed or still
4:56pending and get a clear picture of the
4:58division's work Mr chairman my by its in
5:01action CTP is in blocking consumers from
5:04having access to less harmful products
5:06with a little sign of improvement I
5:08encourage my colleague to support my
5:09bill which would ensure we receive a
5:11clear picture of cp's activities moving
5:14forward I yield back chair thanks
5:17gentlemen now recognize the ranking
5:19member of the subcommitte was spone five
5:20minutes for an opening statement thank
5:23you Mr chairman and thank you for
5:24calling today's important hearing on the
5:26implementation of the Tobacco Control
5:28Act this year marks 5 years since the
5:31Tobacco Control Act became law which for
5:33the first time provided FDA the
5:35authority to regulate tobacco products
5:37the center for tobacco products was
5:39given an enormous but critically overdue
5:41task to protect the public health from
5:43the dangers of tobacco use and many
5:45members of this committee including
5:47myself led by Mr Waxman were proud to
5:50work on this groundbreaking law we've
5:52known for 50 years about the terrible
5:54health effects of smoking tobacco
5:56companies initiated and sustained the
5:58nation's tobacco epidemic and for
6:00decades deliberately misled the public
6:02about the risks of smoking meanwhile new
6:05findings in the latest surgeon general's
6:07report indicate that cigarettes are even
6:08more hazardous and addictive than they
6:10previously were known each year 480,000
6:13Americans die from smoking related
6:15causes and smoking cost the country over
6:18$289 billion dollar in health bills and
6:21lost productivity so I think we can all
6:23agree that the center for tobacco
6:25products has a lofty task moving forward
6:27but I wanted to highlight a few of the
6:29important benefits FDA has begun to
6:31execute they've restricted the sale of
6:33market and marketing of tobacco products
6:35to Children they've set standards for
6:37companies who make claims about the
6:39harms on their products they've
6:41implemented a new science-based Public
6:43Health standard for the review of
6:44tobacco products and they've begun to
6:46review these new product applications of
6:49course there's a lot more work to be
6:50done there are a number of regulatory
6:52actions that I believe still need to
6:53occur to protect the public from the
6:55dangers of other tobacco products and
6:58this includes Banning candy flavored
7:00cigars that appeal to our youth and
7:02ending ecigarette marketing practices
7:04that Target kids we should also raate
7:06taxes on all tobacco products and close
7:08loopholes that led tobacco companies
7:11avoid federal taxes in addition I
7:13believe we must remove barriers to
7:15quitting tobacco use by making certain
7:17that tobacco cessation coverage is
7:20available to all Americans through the
7:21Affordable Care Act Mr chairman I hope
7:24this will be the first in a number of
7:26oversight hearings on the tobacco law
7:28for the past few years my colleagues and
7:30I have asked for tobacco hearings in
7:31fact a most recent request would have
7:33examined the recent alarming Trends in
7:35the currently unregulated tobacco
7:37products like ecigarettes just last week
7:40we learned that about that
7:43about some data came forward that
7:45reports of poisonings caused by
7:47accidental ingestion of e- liquids and
7:50that's the liquid containing nicotine
7:52used to refill ecigarette cartridges uh
7:55that the incident tripled from 2012 to
7:5820 201 3 and while I appreciate the
8:01views of GAO and look forward to miss
8:03cr's testimony and comments today's
8:05hearing should have included the FDA
8:08it's important that we offer our
8:09Administration some courteousness that
8:11includes allowing for sufficient time
8:13and scheduling hearings so I hope you
8:15will ensure that the director of the
8:16center for tobacco products and the FDA
8:19have a legitimate ability to update
8:21members on fda's regulatory efforts I'd
8:24like to uh yield the balance of my time
8:27to the gentleman from New York Mr Engel
8:29if if he would like to use it well I I I
8:32thank my uh my friend for yielding to me
8:35and I want to thank the both the ranking
8:38member and the chairman for holding this
8:40hearing um I want to Echo the comments
8:43of ranking member palone and that I also
8:46wish that this hearing could have been
8:47scheduled at a time that would have
8:49allowed the FDA to participate the
8:51implementation of the family smoking
8:53prevention Tobacco Control Act is
8:56critically important and I think members
8:58of this committee would have have
8:59benefited from hearing the fda's
9:01perspective that being said however I do
9:03appreciate the willingness of GAO to
9:05come here today to testify about their
9:07oversight efforts on the law my district
9:10includes parts of the Bronx where over
9:12100,000 people have
9:14asthma I live in that burrow this burrow
9:16has some of the highest rates of asthma
9:18related emergency room visits in all of
9:19New York this reality is due in no small
9:22part to the prevalence of smoking and
9:24secondhand smoke exposure just Friday a
9:27report by New York State Control Thomas
9:29denapoli found that asthma related
9:31medical expenses and loss productivity
9:34are costing my state an estimated 1.3
9:37billion dollars a year eliminating the
9:39use of tobacco products amongst Children
9:42and Youth can play an important role in
9:44reducing these asthma related costs so
9:47I'm I'm I'm pleased that we are holding
9:49hearings on this today and I look
9:51forward to the testimony and I yield
9:54back chair thanks gentlemen I recognize
9:57the chairman of the full committee Mr in
9:595 minutes ring statement well thank you
10:01Mr chairman you know it has been 5 years
10:03since the family smoking prevention
10:05Tobacco Control Act was signed into law
10:07we have a collective responsibility as
10:09the fda's authorizing committee to
10:11ensure the agency is implementing the
10:14law and all laws in a fair consistent
10:17and transparent manner fda's decision
10:20should always be based on sound
10:22scientific evidence with the health of
10:23our nation citizens in mind the GAO has
10:26done a thorough job overseeing the
10:28implement ation efforts conducted by the
10:31center for tobacco products to date and
10:34their work continues I want to thank Dr
10:37Marsha cross from the outset for her
10:39hard work on this front and for her
10:41responsiveness to the committee staff
10:43GAO has raised a number of concerning
10:46issues about the efficiency and
10:47consistency of cp's regulatory
10:50activities to date for instance they
10:52issued a report in September of last
10:54year noting that the sener had yet to
10:57set any performance measures or review
10:59timelines to ensure accountability Eng
11:02gauge progress I'm a firm believer that
11:05transparency does breed
11:07accountability Congressman Guthrie as he
11:10noted did introduce the transparency and
11:12tobacco user fees act HR 389 which is a
11:15common sense piece of legislation that
11:17would require the FDA to submit annual
11:19reports to Congress on how those user
11:22fees have been spent FDA has such a
11:24statutory requirement for user fee
11:27programs such as PFA and the Insight
11:30gained from such reports has led to
11:33improvements across the board again I
11:35welcome our Witnesses I yield back the
11:37balance I yield the balance of my time
11:39to the vice chair of the health
11:40subcommittee Dr
11:42Burgess I thank the chairman for
11:44yielding um chairman is correct this
11:48subcommittee has an obligation as the
11:50principal authorizing committee that
11:53allowed the center for tobacco products
11:55to be created in the first place we have
11:57a responsibility for its oversight
11:59fact of the matter is they've been up
12:01and running for 5 years and this is the
12:03first hearing and they're not
12:07here we need to know how the agency is
12:10implementing the law we need to know
12:12what taxes they're collecting and how
12:13they're allocating the resources we've
12:16asked these questions over and over
12:17again for five years here's the bottom
12:20line somebody already said it Tobacco
12:22you when used as directed tobacco
12:25products cause 580,000 death deaths
12:29every year the Food and Drug
12:31Administration is charged with seeing
12:32that medicines and devices are safe and
12:35effective 4 180,000 deaths every year
12:39you can't call that safe but a darn sure
12:41is
12:42effective fact of the matter is this
12:45agency never belonged within the Food
12:47and Drug Administration in the first
12:49place I argued against that when the
12:51bill passed 5 years ago I'll continue to
12:54argue against it today but the fact of
12:56the matter
12:57is they are in the same building and as
13:00long as it is as long as they are housed
13:03in the same building it is this
13:04committee's obligation to require an
13:07accounting of how are the user fees
13:10collected how are they spent my
13:13understanding is there's over a billion
13:14dollars in user fees that have been
13:15collected in the 5 years since this
13:17agency was
13:18created and almost half of that remains
13:22unspent to put that number in
13:24perspective it's five times the amount
13:27of user fees collected from Medical
13:28device
13:31manufacturers and we don't have an
13:33accurate accounting as to how the money
13:35has been spent and how it will be spent
13:37we know there were challenges about the
13:38graphic labels and that's tied up in the
13:41courts stakeholders complained of the
13:43lack of any regulatory guidance despite
13:46the fact they were given statutory
13:48Direction by this committee here's the
13:50bottom line since we approved this
13:53agency within an agency has it improved
13:55the health of Americans every statistic
13:58tells us it's it's going in the wrong
14:00direction so this morning where is the
14:03FDA they could not find the time to come
14:06here and
14:07testify in fact this is the third time
14:09this year that they have been asked to
14:11come and testify before this committee
14:14this committee both sides of the Das
14:17Republican and Democrat should be
14:19seriously concerned about the fact that
14:21the FDA the head of the center for
14:23tobacco products will not come to this
14:25committee and testify they're always
14:27traveling they're always out of town
14:29make your other directors available to
14:31us within that same
14:34agency we don't mind hearing from them
14:36we don't always have to hear from the
14:37same person but at least make an effort
14:39to accommodate the committee staff when
14:42they ask you to be here when we have
14:44these hearings the gentlemen you I hope
14:46the GAO can shine light on these
14:51actions I'd like to clarification about
14:53FDA not being here because as I
14:55understand it they were notified last
14:57week a week they said they needed more
14:59time so it sounds like we haven't
15:01accommodated them to be here not that
15:03they haven't accommodated us yeah but
15:05this is It's reclaiming my time this is
15:07the third time that we've asked Mr
15:08Zeller to come here and testify and the
15:10third time that he's been traveling for
15:12a speech or participating in another
15:14event so after the FDA staff informed
15:17the committee staff that Mr Zeller could
15:18not testify on April 7 committee staff
15:21informed the FDA that any or all of the
15:24various office heads within the center
15:26for tobacco products could speak and
15:28testify to their regulatory activities
15:31Food and Drug Administration informed
15:32the committee staff that there wasn't
15:34enough time to draft and clear formal
15:36test testimony by April 7th in response
15:39the committee staff told FDA that we
15:41would not require formal testimony be
15:43submitted an arrangement that we have
15:45previously agreed to in special
15:47circumstances Food and Drug
15:48Administration decided they did not want
15:50to participate without submitting formal
15:52testimony but they were open to
15:54testifying at some point in the future
15:57and I think this sub committee should do
15:59everything it can to ensure that that
16:01condition is met and I yield
16:05back chair now recognizes the uh ranking
16:09member of the full committee Mr Waxman
16:11five minutes for an opening statement
16:12thank you Mr chairman I think we are
16:14making a big to do about nothing FDA has
16:18been offered a number of dates we
16:20wouldn't accept that uh request I don't
16:24think we've accommodated them and uh I I
16:27think this is a little silly if we're
16:29going to have a hearing FDA ought to be
16:31here uh but let's look at the big
16:33picture 20 years ago this subcommittee
16:35held a famous hearing seven tobacco CEO
16:39Executives seven tobacco CEOs testified
16:42at that hearing and denied that
16:44cigarettes are harmful the nicotin is
16:46indictive that they manipulate nicotine
16:49that they certainly wouldn't go after
16:50kids and their
16:51denials that day galvanized the
16:53anti-smoking movement a lot has happened
16:56in the last 20 years smoking r rates
16:58have dropped smokefree laws have become
17:01widespread in 2009 Congress passed the
17:05family smoking prevention Tobacco
17:07Control Act on a bipartisan basis the
17:11tobacco companies are trying to
17:13circumvent this law the law banned the
17:16sale of candy flavored cigarettes so
17:18whether the tobacco companies do they
17:20started selling candy flavored little
17:22cigars the law restricted marketing of
17:25cigarettes and smokeless tobacco to kids
17:28but companies are using the same tactics
17:31to promote ecigarettes to kids we've
17:34asked repeatedly for hearings in this
17:36committee to examine these outrageous
17:38practices but the committee the
17:40committee has refused to hold any
17:43hearings today we are finally holding a
17:46hearing on that law that was passed in
17:492009 which I authored but we're focusing
17:52on a very narrow issue the timelines for
17:56reviewing applications submitt by the
17:59tobacco companies not the public health
18:01issues that American families care about
18:04and FDA is not able to testify because a
18:07committee would not accommodate the
18:09agency's reasonable request for adequate
18:12time to
18:14prepare this is a missed
18:17opportunity in the 50 years since the
18:19first surgeon jail report on smoking
18:22we've made tremendous progress in
18:24reducing tobacco use we've cut adult and
18:27youth smoking rates in half or more we
18:30prevented millions of premature smoking
18:32related deaths since the enactment of
18:34the Tobacco Control Act FDA has
18:37restricted the sale and marketing of
18:39cigarettes and smokeless tobacco to
18:41youth FDA has set standards for
18:44companies that assert their products
18:46reduce harms and the agency has
18:49undertaken reviews of new tobacco
18:51product applications using a new Public
18:55Health standard marking the first time
18:57this industry has been regulated but our
19:00work is far from done these are the
19:03things we ought to be looking at more
19:04than 480,000 Americans die each year
19:07from smoking each day thousands of
19:09children try their first cigarette
19:12cigarette uses declined but we've seen
19:14an alarming increase in the use of candy
19:16flavored little cigars and ecigarettes
19:19by our kids that should concern
19:22us but not at today's hearing there's a
19:26long list of things we need to do first
19:28FDA must continue implementation of the
19:31Tobacco Control Act and take full
19:33advantage of its authorities that's why
19:36I and other members have repeatedly
19:38called on FDA to issue deeming
19:40regulations that will stop companies
19:42from marketing ecigarettes to kids and
19:45using candy like flavors to entice our
19:48kids to smoke secondly we must take
19:51coverage we must make coverage of
19:54debacco cessation more accessible to
19:56current smokers through through the
19:58Affordable Care Act third we must raise
20:01the taxes on all tobacco products and
20:03close the loopholes that L companies
20:05avoid federal taxes like the lower tax
20:08rates for pipe tobacco fourth we must
20:11support effective Public Health
20:13campaigns and Tobacco Control programs
20:16to discourage smoking and fifth we must
20:19encourage other nations to adopt strong
20:22Tobacco Control measures and stop the
20:24tobacco companies from using trade
20:26agreements to challenge the
20:29policies we are unlikely to tackle these
20:31issues during today's hearing so I hope
20:34this will be the first of a series of
20:35hearings into the tobacco industry's
20:38practices and our progress on Tobacco
20:42Control I appreciate jao for testifying
20:45and the work they've done but it just
20:48reminds me that after the series of
20:50hearings that we had in
20:511994 which changed the tobacco issue
20:55forever we hadn't had a hearing in this
20:58committee for many many years after the
21:00Republicans took control until one day
21:03we had a hearing not on all these health
21:06issues but why we shouldn't encourage
21:09people to use smokeless tobacco as a way
21:12to wean off
21:14smoking trade one addiction for another
21:18of course we never invited anybody else
21:20to come in and testify about the other
21:22public health measures that uh were in
21:25place to encourage people and uh help
21:28people give up smoking so you sometimes
21:31wonder is this committee concerned about
21:33public health or are they concerned
21:35about special interest and I put that
21:37question out there for people to think
21:39about you'll back my time chair thanks
21:41and gentlemen that concludes the opening
21:43statements as always the written opening
21:46statements follow all members we made
21:47part of the record we have one panel
21:49today one witness I'll invite our
21:51witness to please uh come to the witness
21:54table and introduce her at this time Dr
21:56Marsha cross director Healthcare US
21:59Government accountability office your
22:01written testimony will be made a part of
22:03the record and you will be given five
22:06minutes to summarize your
22:08testimony um so at this time chair
22:11recognized Dr cross five minutes for
22:13opening statement thank you chairman
22:15pittz ranking member palone and members
22:18of the subcommittee I'm pleased to be
22:20here today as you examine implementation
22:22of the family smoking prevention and
22:24Tobacco Control Act enacted almost 5
22:27years ago
22:28in June 2009 the ACT represents the
22:31first time that FDA has had the
22:33authority to regulate tobacco products
22:36it requires that tobacco manufacturers
22:38submit information to be reviewed by FDA
22:41in order to Market certain new tobacco
22:44products fda's re FDA reviews the
22:47products using a public health standard
22:50taking into account the risks and
22:51benefits of tobacco products on the
22:53population as a whole including users
22:56and non-users
22:59the ACT also established the center for
23:01tobacco products CTP within FDA CTP
23:05implements the act by reviewing
23:07submissions for marketing new tobacco
23:09products enforcing prohibitions on the
23:12sale of certain tobacco products
23:14developing and issuing regulations and
23:16guidance and engaging in public
23:18education about the risks associated
23:21with tobacco product use the ACT also
23:24authorizes FDA to assess and collect
23:26user fees from each tobacco manufacturer
23:29and importer all of cp's activities are
23:33funded exclusively through user fees and
23:36unspent user fees may be carried over
23:38from year to year my statement today
23:41will discuss the extent to which FDA has
23:44spent its tobacco user fees and the
23:46status of ctps reviews of new tobacco
23:49product
23:50submissions at the end of fiscal year
23:522012 just over 3 years after the Tobacco
23:56Control Act was passed CTP had spent
23:59less than half of the user fees it had
24:01collected to that point the time it took
24:03to award contracts contributed to the
24:05center spending less than it had
24:08planned in fiscal year 2013 CTP was able
24:12to award contracts for a number of
24:14activities including media campaigns to
24:17educate youth on the dangers of tobacco
24:19use by the end of last year CTP had
24:23spent over 80% of the approximately 1.75
24:27billion dollar in user fees collected by
24:30that
24:31time turning to product
24:33reviews it has taken FDA a number of
24:36years to begin making decisions on
24:38submissions for new tobacco products
24:41nearly all of the almost 4500
24:43submissions received by CTP were made
24:46under the substantial equivalence or SE
24:49pathway under the SE pathway CTP
24:52determines whether the product has the
24:54same characteristics as a predicate
24:56tobacco product or has different
24:59characteristics that do not raise
25:00different questions of Public Health
25:03about 80% of the SE submissions FDA
25:06received were provisional SE submissions
25:09this means they were received by FDA
25:12prior to a statutory deadline in March
25:152011 allowing the product to be marketed
25:19unless CTP finds that they are not
25:21substantially
25:23equivalent SE submissions received after
25:26that deadline are called regular SE
25:28submissions and these products cannot be
25:31marketed until CTP determines that they
25:33are substantially equivalent to
25:35predicate
25:36products CTP made its first decisions on
25:40SE submissions in June
25:432013 and as of December 31st 2013 CTP
25:48has made a final decision on a total of
25:5030 of the
25:534,490 SE submissions it had received all
25:5730 30 final decisions that is
25:59substantially equivalent or not
26:01substantially equivalent were for
26:03regular SE
26:05submissions in February 2014 CTP made
26:09its first decisions on provisional SE
26:11submissions finding products enforced
26:14emissions to be not substantially
26:16equivalent to predicate products and
26:18issued orders to stop the further sale
26:20and distribution of these four
26:22products CTP officials and manufacturers
26:25told us that several factors increase
26:28the time it took CTP to review SE
26:30submissions such as CTP requests for
26:33additional information from
26:35manufacturers and having to hire and
26:37train
26:39staff however we found that CTP has not
26:42had performance measures that include
26:44time frames for making final decisions
26:46on SE submissions we reported last year
26:50that the lack of such performance
26:52measures limit ctps ability to
26:54reasonably assure efficient operations
26:56and effective results
26:58we recommended that FDA establish such
27:00performance measures and the agency
27:02agreed with our
27:03recommendation as of last week FDA
27:06officials said that they expect to
27:08identify performance measures that
27:10include time frames for some types of
27:13submissions in spring
27:152014 and to implement the measures by
27:18October
27:192014 however the agency has not
27:21determined when it will establish
27:23performance measures for the largest
27:25part of its backlog of submissions the
27:27provisional SE submissions for products
27:30that are currently on the
27:31market in addition although FDA has
27:35increased its staff and training for
27:37staff tobacco industry stakeholders
27:39expressed concerns about whether CTP
27:42will have a sufficient number of
27:44qualified staff to review the current
27:46backlog and also review new submissions
27:49that may be made in the future
27:51particularly if FDA asserts jurisdiction
27:54over new types of tobacco products in
27:57some summary in the past year FDA has
27:59taken a number of steps such as media
28:02campaigns and conducting product reviews
28:04that have begun to result in actions and
28:06final decisions however there are many
28:09remaining challenges for the agency
28:11particularly if it expands the scope of
28:14its authority to include additional
28:16types of tobacco products Mr chairman
28:19this completes my prepared statement I'd
28:20be happy to respond to any questions
28:22that you or members of the subcommittee
28:24may have chair thanks G lady I'll begin
28:26questioning recognizing myself five
28:28minutes for that purpose Dr cross gao's
28:31September 2013 report recommended that
28:35FDA established performance measures
28:38that include time frames for making
28:41decisions and that the agency monitor
28:44performance relative to these time
28:46frames what actions if any has FDA taken
28:50in response to these recommendations um
28:53they agreed with the recommendations and
28:55they've told us that this spring they
28:58will establish time frames for two types
29:01of submissions for the regular SE
29:04submissions and for the exemption from
29:06SE submissions but that's a a subset of
29:09the larger pool um they have not yet
29:12determined when they're going to
29:13establish time frames for the larger
29:16portion of their backlog and that's the
29:18the um uh the early submissions that
29:22were made prior to the March 11th
29:25deadline now these seem like General
29:28good government practices that FDA
29:31should have already implemented without
29:33GAO having to make such a recommendation
29:36are there not time frames for review in
29:39the Tobacco Control Act the Tobacco
29:42Control Act only establish time frames
29:44for review for one type of application
29:47um
29:48and that type of application is one that
29:51requires um more information to be
29:54provided it's one where there is no
29:55predicate product on the market and the
29:58Act established a 180-day time frame for
30:01decisions on those applications it did
30:04not establish time frames um for the the
30:08substantial equivalent submissions which
30:10have made up the vast majority of
30:12submissions that fda's received how does
30:15uh FDA prioritize reviews of the
30:19substantial equivalent submissions um
30:22right now it the officials have told us
30:24that they are prioritizing the regular
30:26SE submissions and those are for
30:28products that are not yet on the market
30:31for products that need uh approval by
30:33FDA before those products can be
30:35marketed um so they're prioritizing ones
30:38for products that are not on the market
30:39among the provisional SE submissions
30:43they have divided those submissions into
30:45four groups uh four tiers uh that they
30:49have assigned risk levels to and they
30:51are prioritizing those that they believe
30:53POS the highest
30:55risk now is it true that some of these
30:57submissions are for products that
30:59actually have reduced levels of harmful
31:02ingredients and if so would there be a
31:04way for FDA to prioritize these types of
31:07submissions um it it's possible but the
31:12um there is a another pathway the
31:14modified risk um tobacco product
31:16submissions FDA has received only seven
31:20submissions um of that type and that's
31:22where the manufacturer is making a claim
31:25that it actually reduces the risk um and
31:29none of those have uh had sufficient
31:31information for FDA to proceed um so all
31:34of those submissions are are at a halt
31:36at this point and withdrawn by the
31:38manufacturer um the the products that
31:42have come in through the regular SE
31:44pathways are not making claims that they
31:47reduce the risk to Public Health
31:49although it is possible that they
31:52could we have heard that one factor
31:54affecting the long time frames for FDA
31:57review is the fact that it took them a
32:00while to get the center for tobacco
32:03products up and running they've had now
32:06five years have they gotten any faster
32:09over time um they have gotten um
32:12somewhat faster in the initial steps
32:15that they go through in determining
32:17their jurisdiction and in determining
32:19the completeness of the application um
32:22particularly for the regular submissions
32:24they now feel that they're at a point
32:25where they can establish some time
32:27frames for those reviews um they have
32:30haven't made enough decisions on the um
32:34the provisional SE submissions for us to
32:36determine whether or not they're getting
32:38any faster there have only been four
32:41decisions all for a single type of
32:42product from a single
32:46manufacturer all right thank you uh
32:48chair recognize the ranking member Mr PL
32:50five minutes for
32:52questions thank you Mr chairman um Dr
32:56cruss in in um April 2011 FDA indicated
33:00that would issue regulations asserting
33:02jurisdiction over additional tobacco
33:04products like ecigarettes little cigars
33:06and pipe tobacco and as you testified in
33:09October FDA submitted a proposed deeming
33:11rule to om but the rule has not yet been
33:13issued by FDA over the past few years
33:16we've seen dramatic increases in the use
33:18of ecigarettes and flavored little
33:20cigars among Youth and there's also
33:22evidence that manufacturer activity
33:24targeting youth has driven this growth
33:25in alternative tobacco products and that
33:28FDA in action made it easier for
33:30manufacturers to do so so I'd like to
33:32find out more about fda's proposed
33:34regulations and the public health cost
33:36of delay and my first question I have a
33:39lot is last week the Centers for Disease
33:41Control and prevention of CD or or
33:43prevention I'm sorry the Centers for
33:46Disease Control and prevention or the
33:48CDC reported that the number of calls to
33:51poison centers involving ecigarette
33:53liquids Rose from one per month in
33:56September 2010 to 215 per month as of
34:00February of this year did you see this
34:02CDC report and if so what were your
34:04impressions um yes I did see the C CDC
34:07report um and I think it it is
34:10concerning because nicotine um in a
34:13liquid form like that can be a potent
34:15poison um with the growth of ecigarettes
34:19um there are more um liquids being
34:24distributed as I understand it for uh
34:27refill purposes both to businesses and
34:30in some quantities for purchase by
34:32individuals um and as with any poison
34:34it's a concern if children can have
34:36access to that well in fact members of
34:38this committee have repeatedly written
34:40to FDA raising the alarm about the
34:42various risks that ecigarettes pose to
34:44Children and adolescents we pointed out
34:47that ecigarette makers are producing
34:49products with kid-friendly flavors such
34:51as cookies and cream milkshake and we've
34:54called on FDA to issue deeming
34:56regulations to bring bring an end to
34:57manufacturers targeting our youth
34:59through aggressive campaigns a campaigns
35:02as well as event sponsorships and other
35:04tactics once used by cigarette
35:06manufacturers so Dr cross last September
35:09CDC reported that between 2011 and 12
35:12the percentage of high school students
35:14who had used ECI cigarettes more than
35:16doubled are you aware of these findings
35:18I have seen the CBC statistics yes and
35:20are you also aware that cdc's director
35:23Dr Tom predin and other experts have
35:25raised concerns that ecigarettes could
35:27be a Gateway product to Conventional
35:28cigarette and other tobacco products use
35:31yes I've seen that statement the
35:33importance of FDA issuing deeming
35:35regulations extends Beyond ecigarettes
35:37flavored cigars for example are also
35:40currently unregulated in October CDC
35:43reported that sales of little cigars
35:45have skyrocketed over the past decade
35:47and more than 40% of middle and high
35:49school students who smoke reportedly
35:51using these flavored products Dr Cross
35:54I'd like to ask you a series of
35:55questions regarding FD A's ability to
35:58take specific actions if the agency
36:00asserts jurisdiction over ecigarettes
36:02and flavored little cigars first could
36:05the agency prohibit the sales of these
36:07products to minor and require age
36:10verification prior to purchase um it is
36:13my understanding that they have that
36:14Authority could the agency prohibit
36:16brand name sponsorships of events that
36:18are widely attended by youth yes I
36:21believe that they could extend that
36:22current prohibition to new products that
36:24were deemed under their control could
36:26FDA prohibit the use of characterizing
36:28flavors that are attractive to kids yes
36:31I believe that they have the authority
36:33and finally could FDA takes steps to
36:36inform the public about the harms of
36:38ingesting inhaling or absorbing
36:40ecigarette nicotine cartridges through
36:42the skin or eyes yes they have authority
36:45to conduct public education campaigns I
36:47just think it's crucial that FDA acts
36:49quickly to deem additional tobacco
36:51products in the absence of Regulation
36:53manufacturers take advantage of
36:55regulatory loopholes PS to Target
36:57impressionable children and teens the
36:59recent surgeon general's report
37:01reiterated what we've known for a long
37:03time that exposure to nicotine in youth
37:06increases the risk of lifelong tobacco
37:08product use so do you have any insight
37:10into why release of the deeming rule has
37:13been delayed I I don't have any
37:16information on that FDA has announced
37:18that its deeming regulation will include
37:20a number of of uh tobacco products that
37:23it does not currently regulate I do not
37:25know what the delays are
37:27for this deeming rule uh I mean if you
37:30know obviously Mr chairman if if if at
37:33any point Dr Pro could get us more
37:36information about you know the delay or
37:38when this is going to come out we would
37:40appreciate your providing the committee
37:42with that in you know in any written
37:44followup if I could ask through the
37:46chairman yes I I I have no information
37:48beyond the commissioner's statement last
37:50week at the Appropriations hearing that
37:52it would be very soon okay so let me
37:54just say that evidence from GA CD C this
37:57committee and others has demonstrated
37:58that the use of ecigarettes little
38:00cigars and other unregulated regulated
38:02products has increased dramatically and
38:05this is due in part to inaction on the
38:06Deon rules so I just can't have to
38:08emphasize Mr chairman that FDA has to
38:10Quick act quickly to assert jurisdiction
38:12over all these tobacco products thank
38:15you chair thanks gentlemen now
38:17recognized gentleman from Kentucky Mr
38:18Guth five minutes for questions thank
38:20you Mr chairman and thank you for coming
38:22today I appreciate that Dr cross do you
38:24have any more data on what the backlog
38:27at CTP looks like and can you let us
38:29know how many of the SE submissions
38:30within the backlog relate to different
38:32category product changes label changes
38:34and name changes it's not just product
38:36changes they can regulate it's label and
38:37name as well I I don't have information
38:40at the moment on that uh we are
38:42conducting further work and we expect to
38:44issue a report in late June that was
38:47mandated by the Tobacco Control Act that
38:49actually will have some additional
38:50information okay thanks and it's my
38:53understanding that and you said that 99%
38:54of submissions to the FDA or SE
38:56substantial equivalents which in theory
38:59these should be quicker to review than
39:00new product submission and yet as you
39:02know it it's taking years for them to be
39:04reviewed an FDA has similar Pathways for
39:06other products and other FDA agencies it
39:08takes roughly five months to review of
39:10510k for medical devices 6 to 10 for new
39:12pharmaceutical drugs come to Market and
39:15the CTP has taking years for these steps
39:17for these sees can you discuss the
39:20approval times at CTP compared to those
39:22of drug and device centers at FDA and in
39:24your opinion does CTP have
39:27why does CD have such a lag on decision-
39:29making when other centers are able to
39:31turn around products in a better manner
39:33well
39:35CTP was starting from scratch and they
39:38indicated that that they had a number of
39:40delays because they they needed to hire
39:42staff they needed to develop a process
39:46um and they needed to to develop the
39:48science around tobacco products um
39:52because these products had not been
39:53previously Rec uh regulated they they
39:56needed to gain an understanding of the
39:58risks posed by different types of
40:00tobacco products uh the constituents
40:03within tobacco products and what risk
40:05might be posed by changes to tobacco
40:07products have they Beyond those points
40:09now or they still uh they still have a a
40:12significant amount of research underway
40:14and in fact that that has uh absorbed a
40:17a lot of the budget of the office of
40:19science which is the the office that um
40:22makes decisions about substantial
40:24equivalents they they say that they are
40:27much further along that process they
40:29clearly are much slower than than the
40:32center for drugs or the the center for
40:34medical devices although I will note
40:36that GAO reported in
40:391983 on the center for devices that had
40:42been established in
40:441976 and we commented at that time that
40:46they were being very slow uh to fulfill
40:50the requirements of their authori so I
40:52think it is an issue when you're
40:53starting up a center from scratch but
40:55during Sub sub subsequent qu
40:57reauthorizations the product
40:59manufacturers and the FDA work through
41:01to try to find a way to work do you
41:02think that Cong in your opinion you
41:04think that Congress should impose
41:06statutory
41:07timelines you know I I don't think I
41:10have enough information to to speak to
41:12that point at this at this point in time
41:15because I think they're still they're
41:17still feeling their way through it and I
41:18think we don't have we haven't had
41:20enough information to base that decision
41:22on there is a concern they have a
41:24concern not not my concern their concern
41:27is that when when a product is approved
41:29through the SE pathway it then can
41:31become a predicate and so they don't
41:33want to make mistakes um because they
41:35want to have an understanding of what
41:36the likely public health impact would be
41:39of a new product because it then becomes
41:42a predicate that a subsequent product
41:44can use okay and then my final
41:47question my legislation would require
41:50the CTP to provide annual reports to
41:52Congress all it does is outlining how
41:54their user fees are being spent
41:56the number of submissions received the
41:58number of applications approved or
42:00denied and the number still pending and
42:02the number of modified risk products
42:04that's what this application does this
42:06what this legislation I propose does in
42:08your opinion is this information that
42:11the CTB has readily available I I mean
42:13if we pass this bill today would that
42:16information be available for the for the
42:18CTP to provide or do you think it be a
42:20burden on the CTP to provide that
42:22information no I believe this is
42:23information that they have readily
42:25available and in fact my understanding
42:27is that the appropriators have put
42:28report language in to do to require
42:30something similar do you think that's
42:32helpful information to have for Congress
42:34to have I I think it's appropriate for
42:36Congress to have information on the
42:38operations of the center there is
42:40already a required report but it does
42:41not require that those specifics be
42:43included and I thank you for coming I
42:45think you you every time you testify you
42:47always do a good job and uh and you do
42:50your your job well and and testify well
42:52I appreciate it very much thank you
42:53thank you and I Y back chair thanks
42:55gentlemen now recognize the gentle lady
42:57Dr Christensen five minutes for
43:01questions thank you Mr chairman good
43:03morning Dr cross morning um thank you
43:05for your testimony I remember when the
43:08law was being drafted and one of the key
43:10issues for the Congressional Black
43:11Caucus for many organizations and for
43:14all of the living uh past HHS
43:17secretaries was a menthol issue and I I
43:20know that FDA was granted broad
43:22authority to address me Menthol as an
43:24additive in cigarettes ranging from
43:26doing nothing to reducing the
43:27concentration to removing Menthol
43:29altogether and I appreciate the approach
43:32FDA has taken around the issue of other
43:33flavorings and the sensitivity my
43:36question to you would be are you able to
43:39provide an update about where FDA is on
43:41the menthal issue in particular what
43:43types of studies have been
43:45conducted um whether mental have they
43:47been able to determine whether mental
43:50exacerbates directly or indirectly the
43:52incidents of lung cancer Etc and if
43:55there are any any preliminary results
43:58I'm afraid I don't have that information
44:00that that's specific to Menthol okay um
44:04well my other
44:05question goes back to the fees um again
44:10we thank you for your testimony on the
44:12fees um my colleagues have commented on
44:14user fee carryover and how the user fees
44:17are being spent I want to make sure the
44:18record is clear on a few points what
44:21portion of fda's tobacco user fees have
44:23been spent as of December 31st 20
44:26they've spent 81% of the user fees
44:28they've received through that time thank
44:31you you mentioned that most of the user
44:32fees were spent by three offices at FDA
44:34one of which was the office of health
44:36communication and education and as you
44:38stated today FDA devoted a portion of
44:41its fiscal year 2013 user fees on a
44:43public health education campaign from
44:45your review of fda's user fee spending
44:48can you tell the subcommittee whether
44:49the agency's user fee spending is
44:52consistent with the purposes and
44:54authorities of the tobacco Control Act
44:56yes we did not identify any spending
44:58that was not uh consistent with their
45:01authorities and and the different
45:03provisions of the Tobacco Control Act
45:06thank you since the investment in the
45:07real cost campaign has come up this
45:09morning I wanted to take a moment to
45:11comment on the importance of this
45:12campaign it's an evidence-based campaign
45:15that launched in February and will
45:16Target millions of Youth between the
45:18ages of 12 and 17 who are already
45:21experimenting with cigarettes that are
45:23open to spoking to smoking so Mr
45:25chairman we know that the vast majority
45:27of current smokers started when they
45:29were kids every day in the US more than
45:313,200 kids smoke their first cigarettes
45:34and more than 700 youth age under 18
45:37become daily smokers so these statistics
45:39underscore the need for targeted youth
45:41tobacco prevention efforts particularly
45:43when you put this investment in context
45:45the amount FDA spent on the real cost
45:48campaign for the entire year was less
45:50than the amount the tobacco industry
45:52spends on marketing and promotional
45:54efforts for a single week and
45:56um well I have some more
45:59time yes um so the ja makes clear that
46:04FDA review of new products must become
46:06more efficient and effective I'm
46:08concerned that they're not placing
46:09enough priority on requiring changes to
46:11products that are already on the market
46:13to make them less harmful or addictive
46:15the um most recent surgeon Generals
46:17Report found that cigarettes are more
46:19dangerous today than they were the first
46:21when the first gen surgeon general's
46:23report on smoking was issued 50 years
46:25ago remarkably cigarette smokers today
46:27have a higher risk for lung cancer than
46:29smokers in 1964 despite smoking smoking
46:32fewer cigarettes the Surgeon General
46:35report also found that some if not all
46:37of this increased risk is likely caused
46:39by changes in the composition and design
46:41of cigarettes fortunately FDA now has
46:44the authority to set product standards
46:46that require changes to products to make
46:48them less harmful or addictive do you
46:51know if FDA plans to respond to the
46:53alarming findings in the more recent
46:55surgeon general's report and if there
46:57are any plans underway for FDA to use
47:00its authority to set product standards
47:02I'm not aware of specific regulatory
47:05actions that FDA may have underway but
47:07they do have a number of different
47:09studies scientific studies to try to
47:12understand I think the impact um and the
47:14risks posed by different constituents in
47:16tobacco products thank you and Mr
47:19chairman I you back the balance of my
47:21time thank you chair thanks gentle lady
47:23now recognized gentlemen from
47:24Pennsylvania Dr Murphy 5 minutes for
47:26questions hello do good to have you here
47:28today thank you um you state in your
47:31report CTP is limited in its ability to
47:34evaluate policies procedures and
47:36Staffing Resources in relation to its uh
47:39substantial equivalence review process
47:41and in turn is limited in its ability to
47:43reasonably assure efficiency and
47:45Effectiveness so in your conversations
47:47with the agency did you get a feel for
47:48how the approval process would be
47:51affected if FDA proposes deeming
47:53regulations for other products that it
47:55doesn't doesn't currently regulate well
47:58certainly industry expressed concerns to
48:00us that um that as if the number of
48:05products to be regulated is greatly
48:06expanded that FDA um will not have
48:10sufficient resources will not have
48:11sufficient staff uh to be able to review
48:14those applications FDA assured us that
48:18they uh believe that the challenges of
48:20initially Staffing the office are behind
48:22them and that they believe they could go
48:24through routine processes if they need
48:26to hire or train additional staff um and
48:29that additional products under their
48:31regulatory Authority would not pose new
48:34challenges will that U fulfill all the
48:36things that they need to do prior to
48:38issuing deeming regulations to make sure
48:40the backlog isn't made worse
48:43um I don't believe that it's required
48:46that they that they uh complete those
48:48steps prior to issuing deeming
48:49regulations I you know we think that
48:51it's important that they that they get
48:54their processes under control control uh
48:56with routine procedures and time frames
48:59established for staff so that they they
49:01can better determine how many staff they
49:03need um we think that without having
49:06those kinds of of benchmarks in place
49:10it's difficult for them to determine for
49:12themselves whether they have the
49:13essential resources and whether there
49:14are bottlenecks in certain Pro Parts of
49:16their process okay U thank you is it
49:19fair to say that reviewing new tobacco
49:21product submissions and approving or
49:23denying them for entrance into the
49:24marketplace
49:26is one of the core functions to the
49:28sener for tobacco products under the
49:29Tobacco Control Act yes it is one of the
49:32core functions and is it also fair to
49:33say that reviewing substantial
49:35equivalence applications is one of the
49:37three main determinations that CTP has
49:40in carrying out it's this core function
49:42of reviewing new tobacco products for
49:44Marketplace suitability um that is part
49:47of their Authority yes good than you
49:49stated in your study CTP is quote
49:51Limited in its ability to evaluate
49:53policies procedures and stat mapping
49:55resources in relation to its substantial
49:58equivalence review process and in turn
50:01is limited in its ability to reasonably
50:03assure efficiency and Effectiveness so
50:06given your r viiew that CTP is limited
50:08in its ability to reasonably assure
50:10efficiency and Effectiveness in this
50:12core function of reviewing SE or
50:14pre-market applications do you believe
50:17CTP is presently capable of handling
50:19even more
50:21responsibilities and a much greater
50:23volume of applications which would
50:24result from the new in rule of CTP and
50:27FDA plan to propose to dramatically
50:28expand its scope of authorities under
50:30the Tobacco Control Act you know I don't
50:32think I have sufficient insight into
50:34that but even if FDA proposes this
50:36steeming I believe it will be a number
50:38of years before um such regulations
50:41would go into effect in the normal
50:43course of how long it takes to get a
50:44regulation in place so there may be a
50:46number of years further before any new
50:50products would actually begin to be
50:52regulated by FDA so I you know I don't I
50:55can't speak to what may happen in the
50:56future in terms of them dealing with
50:58their backlog well we want to work with
50:59you in this but I'm trying to find out
51:01if you have confidence that uh CTP can
51:03at this time given its backlog it
51:05already has of SC applications
51:07efficiently and effectively process a
51:09whole new onslaught of applications that
51:11would rise from a new deeming rule I
51:14think were they to arrive today that
51:16would pose a problem as I say I I can't
51:18predict how soon new product
51:21applications might arrive and what the
51:23their status would be of their backlog
51:25at that point point in time well I'm
51:27what do you infer from the fact that the
51:29I understand there's zero pre-market
51:30tobacco product applications have been
51:32submitted um there's no statutory do you
51:36have any thoughts on that um actually
51:38there were I think believe that there
51:39were four that were submitted but none
51:41were found to have um all of the
51:43information that um FDA required um you
51:47know it's a different standard it it's
51:49not unlike with medical devices where
51:51there are many more uh products that go
51:53through the the 510k process as opposed
51:55to the PMA process here this is for
51:58products where there is no predicate
52:00product that they can point to so there
52:02is not a similar prior product on on the
52:05market before uh February 15 2007 that
52:10they can point to and say this product
52:12is like that or Like An approved product
52:16through the SE Pro process to say that
52:18that's a predicate so so you know as
52:21more products get approved through the
52:23SE uh process may be predicates
52:26available that could continue to to
52:28allow products to go in that pathway P
52:31the the uh pmta process requires a a lot
52:35of different information than
52:37manufacturers may have yet developed I I
52:39hope one of the questions you can answer
52:41in in writing later on is about a new
52:42product review being more complex than a
52:44substantial equivalence review and help
52:46us with that information thank you very
52:47much I'll yield back sure thanks you
52:49gentlemen and now recognizes the vice
52:50chairman of the subcommittee Dr Burgess
52:52five minutes for
52:54questions thank you Mr chairman Dr cross
52:56Welcome to our subcommittee again thank
52:59um I'm sorry I had to step out for a
53:01moment but just tell me if if you've and
53:03I apologize if you've already addressed
53:05this but what is the average time that a
53:07substantial equivalent has been sitting
53:08at the center for tobacco products um
53:11the bulk of the um the applications have
53:15been sitting there since March of
53:192011 um they received over 3,000
53:22applications in the first 3 weeks of
53:24March 201 11 just prior to the deadline
53:27for a provisional SE uh product and so
53:30that those products can be marketed
53:33until FDA makes a decision and so the
53:36bulk of the backlog um has been sitting
53:38there for now more than three years so
53:43you um evaluate other agencies that have
53:48a substantial equivalence pathway do you
53:50not yes we but well the medical devic is
53:52at FDA so is this enough unusual backlog
53:56given your experience with other
53:58substantial equivalence Pathways I do
54:00think it's an unusual backlog I think it
54:02was a bit of an unusual circumstance
54:04because of the deadline that resulted in
54:06this bolus of applications all in a very
54:09short period of time rather than a a
54:11growing steady stream okay given given
54:15that the way that the information was
54:17delivered does it seem to be that
54:20they're accommodating at the center for
54:21tobacco products now accommodating this
54:24bolus that they received
54:25um they have um as of yet only made four
54:29decisions so they they still have that
54:32bolus sitting there they have made some
54:34progress in sorting through it but they
54:37have not yet reached decisions and and
54:41the four decisions that they've reached
54:42were those positive or negative
54:43decisions those were negative decisions
54:46they ordered four products off the
54:47market can you give the committee I
54:50maybe I should know this but can you
54:51give the committee an idea of what were
54:54those products they were four um
54:56products that are called bees I believe
54:58they are an Indonesian type of cigarette
55:01um and they FDA uh said that that
55:04sufficient information on a predicate
55:07had not been um uh supplied by the
55:10manufacturer in order to meet the
55:12standard for um a determination of
55:15substantial equivalence so was that a
55:17product that was already on the shelves
55:19prior to the passage of the CTP um no if
55:22it required a provisional SE application
55:25it would have been a product that came
55:27onto the market in the United States
55:29after February 15 2007 but before March
55:3422nd 2011 so in that window of time
55:38products that came onto the market were
55:40required to submit these provisional SE
55:42applications well what's your uh opinion
55:47on the uh why the center for tobacco
55:49products has this lag in their decision-
55:51making when other centers are able to
55:53turn things around in more time L
55:55fashion well um they did have to staff
55:58up from scratch they had to develop
56:01their procedures they had um they've
56:04they've taken a lot of time they tell us
56:06to try to understand the science of
56:09tobacco um which they did not have
56:11sufficient information on before and
56:13they've now uh engaged both in um in
56:17contracts with CDC and with NIH and with
56:20universities to try to uh gain a better
56:24understanding of the risk posed by
56:26different types of tobacco products and
56:28constituents in tobacco products Dr
56:30cross I believe I could help them there
56:32when uses directed 480,000 deaths a year
56:36um what's there to the science that they
56:38don't understand it's a dangerous
56:40product well the standard requires that
56:43they determine whether or not this new
56:45the new product is any more
56:48dangerous um poses different dangers to
56:51Public Health than the existing products
56:53because the existing products are are
56:55allowed to continue to be marketed so
56:57what if uh Congress were to establish a
57:00timeline um of 90 days for substantial
57:03equivalence applications and 180 days
57:05for new tobacco product applications
57:07would that be helpful or hurtful um I
57:11don't know whether or not they could
57:13meet that standard at the current time
57:16uh there may come a point in time where
57:18where they have regular procedures and
57:20where they do not have such a backlog
57:22but I I don't know if that would help
57:24them or not I just don't have the
57:25information to to say Well it can't be a
57:28resource or or a revenue issue correct
57:31that's correct they tell us that they
57:32now they now have over 500 staff and
57:34they believe that that's a fairly steady
57:36state for them and they have resources
57:38they have not expended all their user
57:39fees 500 staff in an agency that didn't
57:42even exist five years ago and a surplus
57:45of user
57:46fees I I you know I just have to say I'm
57:48mystified as to why why we're having to
57:50study this it shouldn't even be a
57:52problem thank you Mr chairman I'll yield
57:53back
57:55chair thanks gentleman now recognized
57:56gentleman from Texas Mr Green five
57:58minutes for questions thank you Mr
58:00chairman and the ranking member for
58:02having the hearing good a Dr cross for
58:04your testimony the 2009 Tobacco Control
58:06Act was historic and signant legislation
58:09representing the first time FDA was
58:10granted the authority to regulate
58:12tobacco products and I hope this is just
58:15a first series of hearings uh on
58:17implementation of Tobacco Control Act
58:19and I agree with my Texas colleague that
58:22uh this was the first U um Center New
58:26Center in the FDA in 20 years is that
58:28correct um Yes actually it uh and that
58:32was when um the center for devices for
58:34drugs and biologists was divided into
58:36two centers so in even in that situation
58:39it was not creating a center from
58:41scratch okay well and I guess I'm
58:43concerned like he is we have that number
58:45of uh staff members and yet um we're not
58:49moving as quick as we could um the the
58:53law is necessary next step is addressing
58:55tobacco use which is initiated and
58:57sustained by the aggressive and
58:59sometimes dubious strategies of the
59:01tobacco industry it's continued
59:02effective implication would allow the
59:04FDA to reduce tobacco product
59:06addictiveness and harm and take other
59:08necessary actions according to goo
59:10report the tobacco product FDA needs to
59:13set time frames for review process the
59:15FDA Center for tobacco products that
59:17created by the Tobacco Control Act has
59:19gotten off to a slow start and I want a
59:22better understanding what's the uh issue
59:24I understand is conducting your reviews
59:26of tobacco product submissions and the
59:28agency's using new Public Health
59:30standard one that is different than the
59:32safe and effective standard use for
59:34medical products can you describe
59:36describe that standard the FDA must be
59:38using in reviewing these
59:40submissions yes they they need to
59:42understand whether or not the product is
59:43going to pose any um different risks to
59:47Public Health than uh currently uh than
59:51currently legal tobacco products um and
59:54by that that means to the public health
59:56in general both to to the users of those
59:59products but also to non-users to people
1:00:02who may be exposed in other ways um
1:00:04either to fumes or um in some other way
1:00:07to the to the constituents of that
1:00:09product the goo report focused on the
1:00:12need for FDA to establish time frames
1:00:14for making decisions on submissions as a
1:00:16performance measure to improve the CTP
1:00:19review process I want to ask you more
1:00:21out the gao's recommendation and making
1:00:23its recommendation GAO consider other
1:00:25performance measures besides established
1:00:28timelines it could be helpful in
1:00:30reviewing uh the SE submissions in a
1:00:32more timely manner well in part we we
1:00:37particularly focused on the time frames
1:00:38because it was clear that this was
1:00:40taking substantial amounts of time and
1:00:42that they had not established any
1:00:44benchmarks either for individual staff
1:00:46performance or for the performance of
1:00:48the center as a whole um we certainly
1:00:50think it's important that they
1:00:52understand what kinds of guidances are
1:00:54necessary um and what kind of
1:00:56communications with industry may be
1:00:58helpful but also what kinds of
1:01:00information is most important to share
1:01:02with the public uh and it's only in the
1:01:05last year that they've put out those uh
1:01:07major contracts for media campaigns to
1:01:11try to address their responsibility for
1:01:14reducing uh the use of tobacco products
1:01:16by youth okay Mr chairman I appreciate
1:01:19this hearing and hopefully we'll have
1:01:21someone from the FDA because they come
1:01:23to our hearings pretty often and uh to
1:01:26come back and explain what they're doing
1:01:27five years later I also want to remind
1:01:29my colleagues that according to the GAO
1:01:32the vast majority of the substantial uh
1:01:34equivalent backlog for products that can
1:01:37remain on the market while the FDA
1:01:39reviews their applications the majority
1:01:41of the substantial equivalent
1:01:42applications submitted to FDA were
1:01:45incomplete slowing down the review
1:01:46process as the agency had request
1:01:48additional information and await
1:01:50responses from tobacco companies last
1:01:52week the FDA announced one quarter of
1:01:54the regular substantial equivalent
1:01:56applications that already been resolved
1:01:58and FDA has stated the agency's ready to
1:02:00initiate review of any newly submitted
1:02:03applications even as the FDA becomes
1:02:05more efficient in this review process
1:02:07it's important to make sure that the new
1:02:08products coming on the market through
1:02:09the substantial equipment pathway are
1:02:11not causing greater harm to the public
1:02:14health and I would hope our subcommittee
1:02:15would continue to monitor this to see
1:02:19just how the Tobacco Control acts being
1:02:21enforced and uh because a lot of
1:02:23supported it feel like the FDA needs to
1:02:25do their job so I yield Back My Time
1:02:28gentleman yields back chair recognized
1:02:30the gentle lady from North Carolina 5
1:02:31minutes for questions please thank you
1:02:33Mr chairman and thank you Dr cross for
1:02:35being with us today on this issue um I
1:02:38too um was hopeful that a representative
1:02:41from the FDA would be with us I know
1:02:43it's difficult for you to be able to
1:02:45answer some of the questions um you know
1:02:48simply based on the on the study um and
1:02:50report that was put forward and I I know
1:02:53that you you um can see and I think you
1:02:57share with us um you know the questions
1:03:00of of why this hasn't moved quicker than
1:03:04than it should and um I think you've
1:03:06identified a few things one um because
1:03:10they collect the user fees there's
1:03:12plenty of Revenue they've got their
1:03:14staff in place what's left what what
1:03:18what's left to keep them from moving
1:03:20forward in a more timely
1:03:22fashion well one thing that they've told
1:03:24us is that they continue to try to
1:03:27determine exactly what information they
1:03:29may need in applications um
1:03:31representative green was correct and
1:03:33that a number of the initial
1:03:35applications did not contain information
1:03:38that FDA determined subsequently that
1:03:42they needed uh in order to reach
1:03:43decisions now um some of those deadlines
1:03:47required that applications come in prior
1:03:50to FDA putting out guidance on what was
1:03:53was needed and so there has been there
1:03:55has been a lot of back and forth at this
1:03:57point in time though certainly um you
1:04:00know I there there has been sufficient
1:04:02time for I I believe for them to have
1:04:05they should have for for them to have
1:04:06identified what kinds of information
1:04:08they need in an application what point
1:04:10did the FDA put out the guidance for
1:04:13those um application reports I don't I
1:04:16don't have a date in my head I'm sorry
1:04:17we can we can find out if you can if you
1:04:19can get that I would like to know I want
1:04:20to make sure that there are guidelines
1:04:22in place um first of all
1:04:24um but there again I you know I'm kind
1:04:27of stumped and you know I realize that
1:04:29that much of what we do and and the
1:04:31government can be very bureaucratic and
1:04:34and not necessarily move as quickly as
1:04:36the as the private Marketplace but as
1:04:39you can see this is affecting the the
1:04:41the private Marketplace I mean you know
1:04:43obviously there are products who can't
1:04:45move forward and get on the market as a
1:04:47result of this and one of the things
1:04:49that I've been thinking about in
1:04:50relation to this is how does this
1:04:53particular
1:04:55um situation with the Tobacco Control
1:04:57Act and um differ from other um user fee
1:05:04industry related what what's missing one
1:05:06of one of the things and I I I um
1:05:09support my colleague um Brett Guthrie
1:05:12for his legislation and I also um
1:05:15associate my uh self to uh Dr Burg
1:05:19comments on you know setting a timeline
1:05:22in place as well but one of the things
1:05:24that I realize is missing is this can
1:05:27just go on into perpetuity there's no
1:05:30Sundown there's no reevaluation or need
1:05:33for reauthorization of this particular
1:05:36act in your opinion would this be
1:05:39helpful for us to be able to help
1:05:43enforce what the CP CTP is doing you
1:05:47know I don't think I'm in a position to
1:05:48weigh in on whether or not it would be
1:05:50helpful to have it sunset the user fee
1:05:52structure is quite different the
1:05:54responsibilities assigned to FDA under
1:05:57this act are quite different um the user
1:05:59fees are intended to fund not only the
1:06:02reviews of the product applications um
1:06:05as they are in for devices or for drugs
1:06:07for example but also to fund um the
1:06:11research the media campaigns and the
1:06:14enforcement of uh the requirements of
1:06:17the Tobacco Control Act and FDA has
1:06:19undertaken a lot of enforcement actions
1:06:22to try to ensure um um that um teenagers
1:06:26are prevented from having access to
1:06:28purchase tobacco products but at the
1:06:30same time I mean there's obviously you
1:06:32know as you can say um you know and I
1:06:35know you agree with I mean there's
1:06:36there's just this incredible backlog so
1:06:38I mean are there other um situations
1:06:41like this um where we have user fees
1:06:44that are being shared where there isn't
1:06:46a Sundown provision or there isn't a
1:06:48reauthorization in place I you know I'm
1:06:51not I'm not qualified to speak to user
1:06:53fees or across the federal government I
1:06:55don't believe there are similar
1:06:56circumstances at
1:06:57FDA um but there may be user fee
1:07:00programs in other government agencies
1:07:02that that are similar that I just am not
1:07:04aware of okay well there again I you
1:07:07know there I I think I think this is
1:07:09just one of those issues that um you
1:07:11know we're all kind of baffled by you
1:07:14know why this is and it it almost seems
1:07:17as if it's it's not a
1:07:20um organized effort um to to keep things
1:07:24you know products are moving forward and
1:07:26I and I do think um that this is
1:07:28something that that I would like to
1:07:30continue to work on and and there again
1:07:32I I'm out of time thank you very much uh
1:07:35for for coming today and helping us to
1:07:38understand this issue and U Mr chairman
1:07:40I yield back the remainder of my time
1:07:41gentle lady yields back chair now
1:07:43recognizes a distinguished gentleman
1:07:45from Louisiana The Honorable Bill
1:07:46Cassidy five minutes for questions
1:07:48please thank you um hey Dr Ross
1:07:52um the increase in sales of pipe
1:07:56tobacco uh people aren't buying a lot
1:07:58more pipes so I presume they're rolling
1:08:00this in some sort of paper making their
1:08:03own cigarettes um GAO put out a report
1:08:07uh last year that or 2012 rather that
1:08:10that um pointed out a huge shift um in
1:08:14the use of pipe tobacco for roll your
1:08:17own cigarettes um subsequent to the
1:08:20changes in taxation on different types
1:08:22of tobacco products um in the children's
1:08:25um uh Health Improvement program um
1:08:28reauthorization Act of chipra in 2009 uh
1:08:32when taxes were greatly increased on
1:08:35certain types of tobacco products there
1:08:37was a tremendous shift um so that uh
1:08:42consumers were no longer using roll your
1:08:45own tobacco but rather using pipe
1:08:47tobacco for roll your own cigarettes um
1:08:51and we have substantial data pointing to
1:08:54a huge shift in that market and a huge
1:08:56loss of Revenue to the federal
1:08:57government because of that shift can you
1:08:59see can you make a guesstimate as to
1:09:02whether or not there's been any
1:09:05discouragement let me start over if we
1:09:07know that there's a certain amount of
1:09:09regular cigarettes which are purchased
1:09:11and then there's the role your own we've
1:09:13raised taxes on the regular cigarettes
1:09:16does it net look like it's the same
1:09:17amount of tobacco being consumed or is
1:09:19there a decrease in the per capita use
1:09:21of tobacco um the data in that report
1:09:25did not point to any decrease in the
1:09:27overall use of tobacco but rather to a
1:09:30shift in order to avoid tax so we've
1:09:32shifted if you will from something which
1:09:34is at least filtered to something which
1:09:36is unfiltered arguably which has more
1:09:39Health implications by using it
1:09:42unfiltered uh you know some roll your
1:09:44own I believe actually can attach a
1:09:47filter from some machines um and I can't
1:09:50speak to where what the proportion is of
1:09:52the different types of roll your own
1:09:54tobacco um cigarettes that are that are
1:09:56made in these tobacco shops using now
1:09:59pipe tobacco instead of roll your own
1:10:01tobacco now under the family smoking
1:10:03prevention Tobacco Control Act roll your
1:10:06own tobacco is any tobacco product which
1:10:09I'm reading here because of its
1:10:10appearance type packaging labeling is
1:10:12suitable for use or likely to be offered
1:10:15to or purchased by consumers at tobacco
1:10:17for making cigarettes cigarette tobacco
1:10:20is defined as a product consisting of
1:10:22loose tobacco intended for use by
1:10:23consumers in a cigarette in your opinion
1:10:26does the product labeled as pipe tobacco
1:10:29about which you reported in April of 12
1:10:31meet either or both of these definitions
1:10:34um you know the the treasury um which
1:10:38imposes the taxes um indicated that it
1:10:41was difficult for them to make that
1:10:42distinction between the roll your own
1:10:44tobacco and the pipe tobacco um that's
1:10:48sold in tobacco shops um so related to
1:10:52that then let me just just asked
1:10:54specifically are there any provisions in
1:10:56the Tobacco Control Act which permit a
1:10:58manufacturer product which meets either
1:11:00or either definition to exempt to exempt
1:11:03themselves from the ACT simply by
1:11:04labeling their product something other
1:11:07than roll your own could it be the exact
1:11:09same tobacco in this bag it's called
1:11:10roll your own taxt and here it's pipe
1:11:13tobacco not taxt I I can't speak to that
1:11:15I know that the that the pipe tobacco is
1:11:18allowed to be flavored so that if uh
1:11:20it's a flavored product it could not be
1:11:22currently be labeled as roll your own
1:11:25because that's currently U regulated by
1:11:28FDA and flavorings are prohibited but in
1:11:30terms of the the constituents or you
1:11:33know the the um extent to which the
1:11:35tobacco has been finely chopped or it
1:11:37requires a certain blend I don't know if
1:11:39that could be the same okay thank you I
1:11:41will yield the remainder of my time to
1:11:43Mr Guthrie thank you I I one of my
1:11:46colleagues on the other side did uh
1:11:48mention that last week right before this
1:11:50hearing CTP put out that they're working
1:11:53to to get rid of the backlog and since a
1:11:55massive move to get rid of the backlog
1:11:57but as I understand it there are two
1:11:58lines there's one line you get into to
1:12:01say if you get in this line we're going
1:12:02to tell you to go to that line and that
1:12:04Line's the one that matters and all they
1:12:05did was say we're not going to make you
1:12:07go through two lines now you're going to
1:12:08have to go to the back of the other line
1:12:09so there was no the announcement that
1:12:11they made as my understanding did not
1:12:14improve the determinations whether it's
1:12:16safe or unsafe or can be sold or not
1:12:18sold all it did was say we're just going
1:12:20to make one line longer and by getting
1:12:21rid of the other line is that accurate
1:12:24description you know I that's not my
1:12:27understanding of of the announcement
1:12:28that they made I I believe that the
1:12:30announcement focused on the the regular
1:12:32SE submissions and the the line for
1:12:35products that are not currently allowed
1:12:36to be on the market I you know those
1:12:39those provisional sees I would I would
1:12:41restate the the large bolus of
1:12:43applications that's sitting there
1:12:45waiting in the queue those products are
1:12:47currently on the market they they do not
1:12:50have to await an FDA decision to enter
1:12:53the market Market they're on the market
1:12:55they're waiting for a decision about
1:12:56whether or not they can remain on the
1:12:57market or have to be
1:12:59removed so FDA is focusing on working at
1:13:03the backlog of applications for products
1:13:07that cannot enter the market until
1:13:09they've reached a decision that's a
1:13:11smaller uh group um it's um somewhere
1:13:17they they received something over 900
1:13:19applications for those products um and
1:13:22they have reached 30 decisions so that's
1:13:25the backlog my understanding of their
1:13:26announcement is that's the backlog that
1:13:28they're focusing on right now very well
1:13:29gentleman's time has expired the chair
1:13:31now recognize the gentle lady from
1:13:32California five minutes for questions
1:13:34please thank you Mr chairman and Dr
1:13:37cross thank you for your testimony as a
1:13:39public health nurse the issue of tobacco
1:13:41use and our nation's well-being and
1:13:43healthc Care expenditures is one that we
1:13:45cannot ignore thanks to the Tobacco
1:13:48Control Act tobacco companies can no
1:13:50longer Mark light or low tar cigarettes
1:13:54misleading smokers who may otherwise
1:13:56have quit but we do know there is much
1:13:58more we need to do to hold tobacco
1:14:00companies accountable for their
1:14:01marketing and I urg the chairman to hold
1:14:03a hearing on the many issues that ra
1:14:06ranking member Waxman pointed out but
1:14:09especially on ecigarettes and the other
1:14:11other products that continue to be
1:14:13targeted at our young people we should
1:14:16not lose sight of why the Tobacco
1:14:17Control Act requires tobacco companies
1:14:20to receive authorization to Market their
1:14:22products in the first place
1:14:23and I encourage the subcommittee to hold
1:14:25hearings on the continual efforts by
1:14:28tobacco companies to Skirt the Rules as
1:14:30opposed to a hearing like this based on
1:14:33the business concerns of these same
1:14:35companies Dr cross I understand that
1:14:38there were some initial road blocks that
1:14:40slow down the review process for
1:14:42substantial equivalent or SE submissions
1:14:45and are being addressed by
1:14:48FDA that's my understanding okay could
1:14:51you please comment on the extent to
1:14:53which incomplete submissions from
1:14:55manufacturers has been a roadblock uh to
1:14:58the uh review process yes both FDA and
1:15:02manufacturers told us that um incomplete
1:15:05submissions did slow down the review um
1:15:08that manufacturers did not have a good
1:15:11understanding of what information was
1:15:12required or and FDA itself was still
1:15:15developing its understanding of what
1:15:17information it might need in order to
1:15:19reach a decision and so virtually every
1:15:22application that has come in has
1:15:24required some communication with the
1:15:27manufacturer to try to either understand
1:15:30part of the application or to obtain
1:15:32additional information to supplement the
1:15:34application so this clearly needs to be
1:15:36addressed and could you elaborate on the
1:15:38steps FDA has taken to improve its
1:15:41review process well they have um uh
1:15:46undertaken a lot of research to
1:15:48understand the science behind different
1:15:49tobacco products um they have organized
1:15:52their staff and and their procedures um
1:15:54in order to have a number of of uh
1:15:57routine steps that an application goes
1:15:59through so that there now is a
1:16:01jurisdictional review initially and then
1:16:02a completeness review that takes place
1:16:05before a product enters actually the
1:16:07scientific review uh for the merits of
1:16:10the product and so they have organized a
1:16:13process they've developed steps they've
1:16:14identified staff who are responsible for
1:16:17the the different steps of the process
1:16:20but they have yet to complete the
1:16:22process for very many of the
1:16:24applications in September of last year
1:16:27GAO recommended that FDA establish time
1:16:30frames for making decisions on new
1:16:32tobacco product submissions you
1:16:34indicated in your testimony today that
1:16:36FDA agreed with gao's recommendations
1:16:39and plans to identify time frames for
1:16:41decision- making on new tobacco product
1:16:43submission and the agency is is it still
1:16:46on track to identify these time frames
1:16:48this spring um it is on track to
1:16:50identify time frames for the regular SE
1:16:52submission they have not yet decided
1:16:54when they when they will have time
1:16:55frames in place for the provisional SE
1:16:58submissions because they tell us they do
1:17:00not yet have enough experience
1:17:02themselves with getting something
1:17:03through the complete process to know
1:17:05what time frames to establish well it's
1:17:07helpful for the subcommittee to hear
1:17:09that FDA has already agreed to establish
1:17:11and Implement performance measures
1:17:13including decision-making time frames
1:17:15for regular SE
1:17:18submissions excuse me once these
1:17:21standards are in place we can better
1:17:23monitor fda's progress uh as FDA has
1:17:27focused on regular uh SE submissions and
1:17:30continue to undertake these reviews have
1:17:33the review times improved the review
1:17:35times have improved we understand for
1:17:37the regular SE submissions it's not
1:17:39clear that they've re that they have
1:17:41improved for the the provisional SE
1:17:44submissions because they haven't made
1:17:46very many decisions yet so we can't see
1:17:48any kind of trend I see you know for
1:17:51decades the ACA companies deliberately
1:17:53misled the Pu public about the risks of
1:17:56smoking smoking and there's evidence
1:17:58that today's products are perhaps even
1:18:00more harmful and addictive than those
1:18:02from past decades my colleagues on the
1:18:04other side of the aisle have talked
1:18:06about setting time frames for review of
1:18:09these SE submissions Mr chairman we need
1:18:11to hear from FDA about the wisdom of
1:18:14this approach we should be incentivizing
1:18:16tobacco companies to manufacture
1:18:19products that reduce harmfulness not um
1:18:23delay that process further and I yield
1:18:26back the balance of my time CH lady
1:18:28yields back now recognize the gentleman
1:18:30from Virginia Mr Griffith five minutes
1:18:32your questions
1:18:33please thank you very much Mr chairman
1:18:36uh thank you Dr cross for being here
1:18:38today appreciate that uh I was a little
1:18:41concerned with some of the folks who uh
1:18:44said on the other side of the aisle that
1:18:46we needed to be more accommodating I was
1:18:49pleased that the acting chairman went
1:18:51through the list of things that we did
1:18:52to accommodate the
1:18:54FDA uh not only did we say that other
1:18:57people could show up as opposed to the
1:19:00the head of this particular Department
1:19:01maybe some else but that they didn't
1:19:03have to have a a written statement uh
1:19:06that had to be approved in advance we
1:19:08just try we're just trying to get to the
1:19:10information and you know I had to make
1:19:13the comment uh to the acting chair that
1:19:16when I ran for election I thought I was
1:19:18being elected to the United States
1:19:20congress not to uh a discussion
1:19:24committee to
1:19:26accommodate every whim of bureaucracy
1:19:29and so I am a little Disturbed that the
1:19:30FDA didn't bother to send somebody here
1:19:33to testify today uh particularly in
1:19:36light of the fact the accommodations
1:19:37that were made to say okay you don't
1:19:39have to have a written statement you can
1:19:40send somebody who's you know a deputy uh
1:19:43we understand they might say I don't
1:19:46know the answer to that question that's
1:19:47a little bit outside of my realm but
1:19:48I'll get you an answer sometimes those
1:19:50things happen but uh it it is is
1:19:53interesting that uh you know with all
1:19:55the busy schedules that so many of us
1:19:57are keeping uh we were able to have this
1:19:59hearing but nobody from the how many
1:20:02employees did you say there were over
1:20:03500 at this particular division of the
1:20:05FDA yes that none of those 500 and
1:20:08something people could accommodate the
1:20:10United States Congress that being said
1:20:13um I I will say that um the agency you
1:20:16know as it states uh is responsible for
1:20:18advancing the Public Health by helping
1:20:21to uh speed innovation
1:20:23further they State the agency protects
1:20:25promotes the health and safety of all
1:20:26Americans by promoting Innovation that
1:20:28addresses Public Health needs Miss cross
1:20:31is it your opinion that the FDA is able
1:20:33to keep Pace with the advances in
1:20:36science and product tech technology not
1:20:38only for the center for tobacco products
1:20:40but for other Industries it regulates
1:20:43and before you answer let me let me tell
1:20:44you one of the concerns I have is also
1:20:46is working on the the mobile apps that
1:20:49are out there and I've talked to the FDA
1:20:51about this but you can do all all kinds
1:20:53of things uh on your cell phone today
1:20:55that you didn't used to be able to do
1:20:56and I related to them on one occasion
1:20:58that that in Africa a team of doctors
1:21:01were able to put together an $8 hack
1:21:04that would send pictures uh back of of
1:21:07parasites found in children's stool and
1:21:10get it immediately analyzed by somebody
1:21:13in the United States and I said can we
1:21:14use that in in our country if somebody
1:21:17comes up with that or does it have to
1:21:19first go through your regulatory process
1:21:21and the answer was basically
1:21:23well if they're using it to diagnose
1:21:25what type of parasite it is that makes
1:21:27it diagnostic it have to be regulated
1:21:30sometimes it seems they're just not my
1:21:32opinion they're just not able to keep up
1:21:34if you could answer that question both
1:21:36in regard to the Center for tobacco
1:21:38products and in other areas from your
1:21:40observation to the best of your ability
1:21:43well I can't speak directly to the the
1:21:45mobile apps but we have previously um
1:21:49examined activities at FDA and raised
1:21:52some concerns certainly um in the center
1:21:55for devices about their ability to have
1:21:57staff with all of the technical
1:21:59expertise for the rapidly changing
1:22:02Technologies um and uh for the the
1:22:06software that's included in medical
1:22:08devices for example that has been a
1:22:10concern that we've identified in the
1:22:11past and that FDA has acknowledged as a
1:22:13challenge for them I appreciate that I I
1:22:17would say in regard to the tobacco
1:22:19products and and I don't know the answer
1:22:21we all want to know what's in the
1:22:23products what the health effects are of
1:22:24those products and we certainly want
1:22:26them to get that done in a timely
1:22:27fashion I will say that that uh you know
1:22:32when I was in the fourth grade growing
1:22:33up in Virginia they used to teach us the
1:22:35history that the first uh one of the
1:22:37first times that somebody was smoking a
1:22:39cigar walking down the Streets of London
1:22:41somebody ran into a local store where
1:22:43they all kept uh water buckets in case a
1:22:45fire broke out and threw water on the
1:22:46man cuz he was on fire he had smoke
1:22:47coming out of his mouth so it would seem
1:22:50to me that if we could get to some more
1:22:51of these smokeless products it would
1:22:52probably help folks that's the gut
1:22:54reaction I'd like to see the science on
1:22:56it do you think that they're going to be
1:22:58able to get us some more of that and and
1:23:00reduce this backlog dramatically in the
1:23:02next couple of
1:23:03years well with regard to to smokeless
1:23:06products I think that that depends upon
1:23:08the applications that are submitted to
1:23:10them that's dependent upon the industry
1:23:12some of those products are currently not
1:23:14deemed to be subject to FDA regulation
1:23:17and so products of those types can enter
1:23:20the market right now um I think that
1:23:23there's not currently a sufficient
1:23:25understanding though of the risks posed
1:23:27by those products and whether or not
1:23:29they simply allow someone who smokes to
1:23:33um co-use those types of products um or
1:23:37you know or use those products in
1:23:39situations where they they can't use a
1:23:42cigarette because of restrictions on
1:23:44where they can smoke or whether or not
1:23:46it allows them to cease use of tobacco
1:23:48products which we do know is dangerous
1:23:50to their health yeah and we certainly
1:23:52need need to get the answers to these
1:23:53questions because you know even a number
1:23:55of uh Healthcare individuals have
1:23:57indicated that there's a good
1:24:00possibility that uh things like the
1:24:02ecigarette May uh be a step in between
1:24:06uh smoking the the smoked tobacco and
1:24:09moving away from using the product at
1:24:12all yes of course if they're making
1:24:14smoking cessation claims then they would
1:24:16be subject to to regulation as a as a
1:24:19drug and subject to regulation in a
1:24:22different part of FDA so um you know I
1:24:25think the concern is whether or not they
1:24:26become a Gateway product to allow young
1:24:30people to then begin smoking cigarettes
1:24:32and I think the science is just not
1:24:33there yet to know yes ma'am I appreciate
1:24:35that and I hope that the uh the sener
1:24:37will get to work and get it done thank
1:24:38you so much and I yeld back gentleman's
1:24:40time has expired the chair now
1:24:42recognizes gentleman from Illinois Mr
1:24:43shimkus five minutes for your questions
1:24:45please thank you Mr chairman um if I get
1:24:47the staffer to
1:24:50move Mike Bill Rock
1:24:57got billus oh yeah well anyway your
1:24:59staffer get him to move
1:25:02thanks Mike's dad that's his dad former
1:25:05me Committee Member it's easy
1:25:07mistake so um welcome and actually I'm
1:25:11following a lot of Morgan's comments a
1:25:12lot of comments other other folks have
1:25:14made um but I want to I want to start
1:25:17with I was going to flip the questions
1:25:20around but you ended up with this whole
1:25:21um if if there's a statement of smoking
1:25:26cessation claims that goes into
1:25:29another pot or another area of
1:25:32Regulation versus just a tobacco use
1:25:36product is that correct that's my
1:25:38understanding yes and um because of
1:25:42another uh former colleague uh not Mike
1:25:45B rockus but Steve buer when we passed
1:25:48this bill in 2009 kept trying to address
1:25:52these issues of um uh
1:25:55nicotine
1:25:57gum uh
1:25:59snoo and now you could make some debate
1:26:03about ecigarettes
1:26:05that um that yes do provide uh nicotine
1:26:11to the individual
1:26:13consumer but you could also argue
1:26:15especially with e cigarettes that in the
1:26:17vaporized form versus a burning form and
1:26:20all those issues there may be some
1:26:25health benefits over a burned tobacco
1:26:30product is is kind of the the the debate
1:26:34and I don't I so in this process we need
1:26:39to get the
1:26:40FDA to to move uh in in the direction of
1:26:46make evaluating this right shouldn't FDA
1:26:50in essence be like the referee on the
1:26:52court and and making judgments well I
1:26:56think that the the statute gives them
1:26:58that Authority and that responsibility
1:27:01um and that they're they've announced
1:27:03that they um intend to deem additional
1:27:06tobacco products um and as I understand
1:27:09it virtually all additional tobacco
1:27:11products as subject to their
1:27:13regulation and so intent de deem I guess
1:27:17that's part of the reason why we're here
1:27:18right how long does it take to have an
1:27:21intent to
1:27:22deem then how long should it well
1:27:26um Ru making as I'm sure you're aware is
1:27:30typically a years long process um they
1:27:32first announced their intent to deem in
1:27:362010 but it was not clear whether they
1:27:39at that time intended to deem all
1:27:41products at once or uh product after
1:27:44product individually um my understanding
1:27:47is that they now have made a determin a
1:27:49determination to deem multiple products
1:27:51at one time um and so therefore needed
1:27:54to develop the information to support
1:27:56that Ru making
1:27:58um we had other work that had examined
1:28:01rule making at FDA that had a range of
1:28:03one year to 14 years so this is still in
1:28:06that range yeah but the importance of
1:28:08the intent to deem is to fully Ed to
1:28:12provide information to the consuming
1:28:14public the adult consuming public
1:28:16correct well yes and to and to make
1:28:19determinations about um the the safety
1:28:23and and controls that might be required
1:28:25for different types of products because
1:28:27they should be using science and
1:28:29evidence in this decision-making process
1:28:31correct and that that is what they are
1:28:34um saying that they are trying to
1:28:36develop is the scientific base to
1:28:39understand the risks posed by different
1:28:41types of tobacco products and we would
1:28:42hope they would do that sooner rather
1:28:44than later for all of us involved I I
1:28:47would think that would be the argument
1:28:48and then on the the my time's running
1:28:50short but also following up on on
1:28:52Morgan's um comment's um uh technology
1:28:57and and moving rapidly bureaucracy does
1:28:59not we fight that issue across the board
1:29:02in the Telecom world and you talked
1:29:03about apps but what about uh is the uh
1:29:06the fda's ability to keep up with the
1:29:09Innovation and Science and product
1:29:11technology uh for the center for tobacco
1:29:15Pro uh products have you seen that
1:29:17that's lagging also well I think it's
1:29:20too soon to say whether it's lagging I
1:29:22think they've just been mounting it in
1:29:24the last several years and so um you
1:29:27know I think that's what frustrates a
1:29:28lot of us here and I know people uh
1:29:31there is a role for government but in
1:29:33the private sector you can't mount
1:29:35something three years you you you would
1:29:38never you would never have a product
1:29:40you'd never have a return on investment
1:29:42and and your oppon your uh your
1:29:44competitors would move right past you so
1:29:46uh we would we would wish that they
1:29:47would move expeditiously and thank you
1:29:49Mr chairman I yield back gentleman
1:29:51yields back chair now recognizes the uh
1:29:54that being all the members of the
1:29:55subcommittee chair now recognizes Mr
1:29:57bakus five minutes for questions
1:30:00please yeah yeah either one I can get M
1:30:02either one in short notice if you want
1:30:04him thank you but I am a member of the
1:30:06subcommittee as well but the uh turning
1:30:08to thank you very much for appearing
1:30:10today I appreciate it very much doctor
1:30:12turning to Staffing levels at the center
1:30:14for tobacco products how many FTE are
1:30:16currently in the various offices uh my
1:30:20understanding is that they currently
1:30:21have a total of about 511 staff and the
1:30:25figures that I have are that the office
1:30:27of science which is this the office that
1:30:29makes the decisions on product reviews
1:30:32um they have 194 staff and that um the
1:30:37office of Health Communications has 44
1:30:40staff and the office of enforcement
1:30:42compliance and enforcement um has 116
1:30:45staff thank you do most of these
1:30:47employees have previously exper
1:30:49experienced regulating tobacco products
1:30:51and other government agencies uh no
1:30:54because tobacco products weren't
1:30:55regulated um previously and so uh they
1:30:58may have experience in regulating
1:31:01products but not necessarily tobacco
1:31:03products they did bring in a number of
1:31:05scientists who had done research on
1:31:07tobacco products but not for purposes of
1:31:09Regulation thank you uh next question
1:31:12has FDA implemented the small business
1:31:14Provisions included in the statute uh
1:31:17including the establishment or the
1:31:18office to assist small tobacco
1:31:20manufacturers for the provis ision of
1:31:22technical assistance and has the agency
1:31:25issued any small business guidance you
1:31:27know I'm not certain um we can get back
1:31:29to you on that I know that they have had
1:31:32some um some implementation in that area
1:31:35but we did hear concerns from
1:31:37manufacturers um that that was an issue
1:31:39for them in terms of um being able to
1:31:41get the information that they needed
1:31:43you're not sure about the uh small
1:31:45business guidance I'm just not sure I I
1:31:47don't think that I that we looked at it
1:31:49explicitly okay you you'll get back to
1:31:51me yes we will thank you very much
1:31:53anybody like some time here thank you
1:31:55I'll go back Mr chairman gentlemen
1:31:57yields back um that concludes questions
1:32:01by the members of the subcommittee I
1:32:04would remind all members they have 10
1:32:05business days to submit questions for
1:32:07the record and ask the witness to
1:32:09respond to the questions promptly
1:32:12members should submit their questions by
1:32:13the close of business on Tuesday April
1:32:1622nd without objection the subcommittee
1:32:19is adjourned to thank the
1:32:20witness
1:32:28for

About this transcript

This page contains the full transcript of Hearing on "Examining the Implementation of the Tobacco Control Act" by Energy & Commerce Democrats, generated from the public captions YouTube serves with the video. The transcript has 15,377 words across 2,334 segments, with the original timestamps preserved so you can click any line to jump to that moment in the embedded player.

What you can do with it

Use the transcript to take notes, quote the speaker, build a study guide, generate a summary with ChatGPT or Claude via the YouTube Summary tool, or export it as a timed subtitle file with YouTube to SRT. You can also re-open it in the transcriber to translate the transcript into 100+ languages.

Free YouTube transcript tool

YouTube2Text is a free YouTube transcript generator — no signup, no daily limit. Paste any YouTube link and get the full transcript instantly, with timestamps, click-to-jump, translation to 100+ languages, AI prompts for ChatGPT, Claude, and Gemini, and exports to TXT, SRT, VTT, or Markdown.