[House Hearing, 113 Congress]
[From the U.S. Government Publishing Office]
EXAMINING CONCERNS REGARDING FDA'S
PROPOSED CHANGES TO GENERIC DRUG
LABELING
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON HEALTH
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED THIRTEENTH CONGRESS
SECOND SESSION
__________
APRIL 1, 2014
__________
Serial No. 113-132
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
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COMMITTEE ON ENERGY AND COMMERCE
FRED UPTON, Michigan
Chairman
RALPH M. HALL, Texas HENRY A. WAXMAN, California
JOE BARTON, Texas Ranking Member
Chairman Emeritus JOHN D. DINGELL, Michigan
ED WHITFIELD, Kentucky Chairman Emeritus
JOHN SHIMKUS, Illinois FRANK PALLONE, Jr., New Jersey
JOSEPH R. PITTS, Pennsylvania BOBBY L. RUSH, Illinois
GREG WALDEN, Oregon ANNA G. ESHOO, California
LEE TERRY, Nebraska ELIOT L. ENGEL, New York
MIKE ROGERS, Michigan GENE GREEN, Texas
TIM MURPHY, Pennsylvania DIANA DeGETTE, Colorado
MICHAEL C. BURGESS, Texas LOIS CAPPS, California
MARSHA BLACKBURN, Tennessee MICHAEL F. DOYLE, Pennsylvania
Vice Chairman JANICE D. SCHAKOWSKY, Illinois
PHIL GINGREY, Georgia JIM MATHESON, Utah
STEVE SCALISE, Louisiana G.K. BUTTERFIELD, North Carolina
ROBERT E. LATTA, Ohio JOHN BARROW, Georgia
CATHY McMORRIS RODGERS, Washington DORIS O. MATSUI, California
GREGG HARPER, Mississippi DONNA M. CHRISTENSEN, Virgin
LEONARD LANCE, New Jersey Islands
BILL CASSIDY, Louisiana KATHY CASTOR, Florida
BRETT GUTHRIE, Kentucky JOHN P. SARBANES, Maryland
PETE OLSON, Texas JERRY McNERNEY, California
DAVID B. McKINLEY, West Virginia BRUCE L. BRALEY, Iowa
CORY GARDNER, Colorado PETER WELCH, Vermont
MIKE POMPEO, Kansas BEN RAY LUJAN, New Mexico
ADAM KINZINGER, Illinois PAUL TONKO, New York
H. MORGAN GRIFFITH, Virginia JOHN A. YARMUTH, Kentucky
GUS M. BILIRAKIS, Florida
BILL JOHNSON, Missouri
BILLY LONG, Missouri
RENEE L. ELLMERS, North Carolina
(II)
Subcommittee on Health
JOSEPH R. PITTS, Pennsylvania
Chairman
MICHAEL C. BURGESS, Texas FRANK PALLONE, Jr., New Jersey
Vice Chairman Ranking Member
ED WHITFIELD, Kentucky JOHN D. DINGELL, Michigan
JOHN SHIMKUS, Illinois ELIOT L. ENGEL, New York
MIKE ROGERS, Michigan LOIS CAPPS, California
TIM MURPHY, Pennsylvania JANICE D. SCHAKOWSKY, Illinois
MARSHA BLACKBURN, Tennessee JIM MATHESON, Utah
PHIL GINGREY, Georgia GENE GREEN, Texas
CATHY McMORRIS RODGERS, Washington G.K. BUTTERFIELD, North Carolina
LEONARD LANCE, New Jersey JOHN BARROW, Georgia
BILL CASSIDY, Louisiana DONNA M. CHRISTENSEN, Virgin
BRETT GUTHRIE, Kentucky Islands
H. MORGAN GRIFFITH, Virginia KATHY CASTOR, Florida
GUS M. BILIRAKIS, Florida JOHN P. SARBANES, Maryland
RENEE L. ELLMERS, North Carolina HENRY A. WAXMAN, California (ex
JOE BARTON, Texas officio)
FRED UPTON, Michigan (ex officio)
(III)
C O N T E N T S
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Page
Hon. Joseph R. Pitts, a Representative in Congress from the
Commonwealth of Pennsylvania, opening statement................ 1
Prepared statement........................................... 2
Hon. Frank Pallone, Jr., a Representative in Congress from the
State of New Jersey, opening statement......................... 4
Hon. Henry A. Waxman, a Representative in Congress from the State
of California, opening statement............................... 5
Hon. Fred Upton, a Representative in Congress from the State of
Michigan, prepared statement................................... 6
Witnesses
Janet Woodcock, M.D., Director, Center for Drug Evaluation and
Research, U.S. Food and Drug Administration.................... 7
Prepared statement........................................... 9
Answers to submitted questions............................... 128
Michael D. Shumsky, Partner, Kirkland & Ellis, LLP............... 41
Prepared statement........................................... 43
Ralph G. Neas, President and CEO, Generic Pharmaceutical
Association.................................................... 48
Prepared statement........................................... 51
Answers to submitted questions............................... 139
Allison M. Zieve, General Counsel, Public Citizen................ 66
Prepared statement........................................... 68
Submitted Material
Material submitted by Mr. Pitts.................................. 85
EXAMINING CONCERNS REGARDING FDA'S PROPOSED CHANGES TO GENERIC DRUG
LABELING
----------
TUESDAY, APRIL 1, 2014
House of Representatives,
Subcommittee on Health,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 3:01 p.m., in
room 2322 of the Rayburn House Office Building, Hon. Joseph
Pitts (chairman of the subcommittee) presiding.
Members present: Representatives Pitts, Burgess, Shimkus,
Gingrey, Lance, Guthrie, Bilirakis, Pallone, Green, Barrow,
Christensen, Sarbanes, and Waxman (ex officio).
Also present: Representative Braley.
Staff present: Clay Alspach, Chief Counsel, Health; Noelle
Clemente, Press Secretary; Paul Edattel, Professional Staff
Member, Health; Sydne Harwick, Legislative Clerk; Robert Horne,
Professional Staff Member, Health; Carly McWilliams,
Professional Staff Member, Health; Chris Sarley, Policy
Coordinator, Environment & Economy; Heidi Stirrup, Health
Policy Coordinator; John Stone, Counsel, Health; Tom Wilbur,
Digital Media Advisor; Ziky Ababiya, Democratic Staff
Assistant; Eric Flamm, Democratic FDA Detailee; Karen
Lightfoot, Democratic Communications Director and Senior Policy
Advisor; and Karen Nelson, Democratic Deputy Committee Staff
Director for Health.
OPENING STATEMENT OF HON. JOSEPH R. PITTS, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA
Mr. Pitts. The subcommittee will come to order. The chair
will recognize himself for an opening statement.
One of the great successes in healthcare in the past 30
years has been the introduction and widespread use of generic
drugs, saving patients and taxpayers trillions of dollars.
Today, nearly 85 percent of drugs dispensed in the U.S. are
generics. This success has been possible because consumers and
prescribers have confidence that generic drugs approved by the
FDA are the ``same'' as their brand name counterparts, not only
in terms of their chemical composition, but also with respect
to their safety and effectiveness.
This principle of ``sameness'' is the backbone of the 1984
Hatch-Waxman Act, which provided the pathway for generic drugs
to come to market. A generic product has the same benefits and
risk as the brand name drug and, therefore, the same labeling
is required. Ever since enactment, FDA has logically held that
this is an ongoing requirement that extends beyond the date of
approval. However, on November 13, 2013, the FDA issued a
proposed rule that would allow manufacturers of generic drugs
to unilaterally change their safety-related labeling, deviating
from the brand. Both FDA's legal and policy rationale for this
change is dubious at best.
Currently, a generic can only change its label when the
branded drug does so and FDA approves the change. In that case,
all generics are then required to adopt the same new labeling
in a timely manner. This system does not obviate the need for
generics to bring new safety-related information to the agency
as soon as possible.
Ostensibly, the proposed change is designed to help speed
newly acquired safety information about drugs to the consumer.
However, FDA has not explained how this rule would actually
improve communication of drug safety information to prescribers
and patients other than establishing a Web site on which they
will post the various labeling proposals.
The only outcome I see if the rule is enacted is mass
confusion. The FDA-approved labeling would essentially become
just one in a crowd. The proposed rule undermines the
``sameness'' requirement in Hatch-Waxman and will result in
situations where multiple FDA-approved, therapeutically
equivalent products will have different safety-related labeling
prior to the FDA determining whether such changes are even
necessary or appropriately tailored.
Not only is the proposed rule in direct conflict with the
plain language of the statute, but it directly contradicts
numerous FDA statements and assertions over the years that
consistent drug labeling is necessary if consumers and
prescribers are to have confidence that generic drugs are as
safe and effective as the reference brand name product.
Finally, FDA has admitted that the proposed changes will
open generic manufacturers up to greater liability under state
tort lawsuits. The added cost of litigation will also cause
generic prices to rise exponentially.
I thank all of our witnesses for being here today to
discuss these important issues. I look forward to your
testimony, and I yield the remainder of my time to Dr. Burgess.
[The prepared statement of Mr. Pitts follows:]
Prepared statement of Hon. Joseph R. Pitts
The subcommittee will come to order.
The Chair will recognize himself for an opening statement.
One of the great successes in health care in the past 30
years has been the introduction and widespread use of generic
drugs, saving patients and taxpayers trillions of dollars.
Today, nearly 85% of drugs dispensed in the U.S. are
generics.
This success has been possible because consumers and
prescribers have confidence that generic drugs are approved by
the FDA as the ``same'' as their brand name counterparts-not
only in terms of their chemical composition, but also with
respect to their safety and effectiveness.
This principle of ``sameness'' is the backbone of the 1984
Hatch-Waxman Act, which provided the pathway for generic drugs
to come to market. A generic product has the same benefits and
risks as the brand name drug and, therefore, the same labeling
is required. Ever since enactment, FDA has logically held that
this is an ongoing requirement that extends beyond the date of
approval.
However, on November 13, 2013, the FDA issued a proposed
rule that would allow manufacturers of generic drugs to
unilaterally change their safety-related labeling, deviating
from the brand. Both FDA's legal and policy rationale for this
change is dubious at best.
Currently, a generic can only change its label when the
branded drug does so and FDA approves the change. In that case,
all generics are then required to adopt the same new labeling
in a timely manner. This system does not obviate the need for
generics to bring new safety-related information to the agency
as soon as possible.
Ostensibly, the proposed change is designed to help speed
newly acquired safety information about drugs to the consumer.
However, FDA has not explained how this rule would actually
improve communication of drug safety information to prescribers
and patients other than establishing a Web site on which they
will post the various labeling proposals.
The only outcome I see if the rule is enacted is mass
confusion. The FDA-approved labeling would essentially become
just one in a crowd.
The proposed rule undermines the ``sameness'' requirement
in Hatch-Waxman, and will result in situations where multiple
FDA-approved, therapeutically equivalent products will have
different safety-related labeling prior to the FDA determining
whether such changes are even necessary or appropriately
tailored.
Not only is the proposed rule in direct conflict with the
plain language of the statute, but it directly contradicts
numerous FDA statements and assertions over the years that
consistent drug labeling is necessary if consumers and
prescribers are to have confidence that generic drugs are as
safe and effective as the reference brand name product.
Finally, FDA has admitted that the proposed changes will
open generic manufacturers up to greater liability under state
tort lawsuits. The added costs of litigation will also cause
generic prices to rise exponentially.
I thank all of our witnesses for being here today to
discuss these important issues, and I look forward to your
testimony.
Thank you, and I yield the remainder of my time to --------
----------------------------------.
Mr. Burgess. Thank you, Mr. Chairman. And again, Dr.
Woodcock, thank you for joining us this afternoon.
For the past 30 years since the passage of the Hatch-Waxman
amendments to the Food, Drug, and Cosmetic Act, a framework
based on sameness between generic and brand name labeling has
existed. Those amendments to the Food, Drug, and Cosmetic Act
successfully created a safe and effective means by which safety
information is relayed to the public. The Food and Drug
Administration's proposed rule has the potential to upend three
decades of stability, and unfortunately, upend the stability in
a process that is working and working well. Allowing generic
manufacturers to update safety labels unilaterally will lead to
a fragmented system where confusion will abound. Multiple
versions of important safety information existing for the same
drug will result in confusion for patients and providers alike.
As a doctor, when I prescribe a drug, brand or generic, I
want to know what the indications and risks are, I want to know
that a generic is truly a generic with the same indications and
the same side effects of the brand. If I am not sure, then why
not just prescribe the brand drug and never mind about the cost
savings?
Mr. Chairman, if patients and doctors don't have the
certainty the benefits of utilizing generics, including cost
savings could very well be at risk. Confusion extending to
patients and pharmacists will accomplish nothing and could lead
to an increase in issues with prescribing medication and the
overall health of our beneficiaries. This appears to be the
latest in a string of proposed rules in which the
Administration is seeking a solution for a problem that simply
does not exist. Safety is paramount.
I thank the chairman for holding the hearing and I will
yield back the balance of my time.
Mr. Pitts. The chair thanks the gentleman and recognizes
the ranking member, Mr. Pallone, 5 minutes for an opening
statement.
OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF NEW JERSEY
Mr. Pallone. Thank you, Chairman Pitts, for having this
hearing.
The issue regarding generic drug labeling and its impact on
patient safety is an important one and merits a thoughtful
discussion. Hatch-Waxman is a true success story, one of the
many that my colleague, Mr. Waxman, has been part of in his
great career here. And because of this groundbreaking law
passed 30 years ago, the drug market has transformed.
Today, more than 80 percent of all drugs dispensed are
generic drugs. In fact, for 45 percent of generics sold, no
branded product is currently on the market. So I think we all
agree that this is a good thing for patients and payers.
But despite this reality, the FDA's regulation over the way
in which generic drugs are labeled has remained unchanged, and
I believe that in order for consumers and doctors to have
confidence in the drugs that they take and prescribe, the FDA
should facilitate a process which ensures that the
responsibilities upon drug manufacturers reflect the current
marketplace.
Last November, FDA proposed a regulation that would allow
makers of generic drugs to update safety labels independently
without waiting for FDA approval to reflect new information on
safety issues. This is identical to the process that brand name
drugs use to communicate safety issues as timely as possible.
This proposal is also the result of a troubling decision by the
Supreme Court in 2011 that generic drug manufacturers cannot be
held liable under state tort law for an inadequate labeling,
and therefore, patients who have been injured by inadequately
labeled drugs have no recourse in court.
Being able to hold manufacturers accountable for
maintaining adequate labeling through the court system is an
important added layer of a consumer protection. And what you
will hear directly from the law's author is that Congress never
intended to give generic drug companies immunity from
liability. In fact, prior to 2011, they did not get immunity.
And so I appreciate that FDA's proposal would address this
interest. I agree that something needs to be done.
Today, we will hear from critics about the consequences of
the proposed regulation, in particular, that it will lead to
over-warning, higher generic drug prices, and the potential for
some companies to even stop making certain drug products. These
are bold claims so I am interested in better understanding the
basis for their views.
I believe the FDA has taken a critical step forward for
patient safety but I do have questions about FDA's approach.
One issue in particular is that of sameness. Hatch-Waxman
established the important principle of sameness for generic
drugs relative to their branded counterparts and this principle
is significant in many ways, not the least of which is to
ensure consumer confidence that generic drugs are just as safe
and efficacious as brand name drugs. So I am interested in
learning more about FDA's consideration of the sameness
principle, in particular, how such temporary differences in
labeling as a result of this proposal may impinge on the
benefits afforded by sameness.
And, Mr. Chairman, this is a proposed rule, like with all
other regulations, FDA will and should take a serious look at
the many comments that they are sure to receive. But I want to
make no mistake about it; I do support their efforts. In
today's marketplace, consumers must have confidence in the
generic drug industry and I look forward to our witnesses'
testimony and I thank them for their participation.
And I would yield back at this time.
Mr. Pitts. The chair thanks the gentleman and now
recognizes the ranking member of the full committee, Mr.
Waxman, for 5 minutes for an opening statement.
OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA
Mr. Waxman. Thank you, Mr. Chairman.
Ordinarily, you would go to your side of the aisle? Oh, I
see. OK.
It has been 30 years since enactment of the Hatch-Waxman
generic drug law. This law has been a tremendous success if I
don't say so myself. Over 80 percent of prescriptions in the
United States are generic. Consumers and payers have saved over
$1 trillion over the last decade alone.
Today, we are looking at one aspect of this law, and in
particular, in light of the proposed rule by the Food and Drug
Administration, to give generic drug manufacturers the same
rights and responsibilities as brand name drug manufacturers to
temporarily update safety information in their labeling without
waiting for FDA approval.
The proposed rule, if finalized in its current form, would
be an important step forward for patient safety. It would
remove obstacles to getting new safety information about drugs
to doctors and patients at the earliest possible time. It would
also restore the added incentive provided by state tort
liability for generic manufacturers to comply with their
obligations to conduct robust post-market monitoring and to
keep their drug labels accurate and up-to-date. And it would
restore the ability of patients harmed by taking an
inadequately labeled generic drug to pursue redress through the
courts just as they were able to do before the Pliva v. Mensing
Supreme Court decision in June 2011.
Now, critics of the proposed rule have argued that it will
lead to over-warning. They have argued that it will result in
higher generic drug prices. They have argued that it will drive
generic drug companies out of business or cause them to stop
making certain products. And they have argued that it conflicts
with the sameness required in the Hatch-Waxman Act.
I don't believe those claims. We have heard the exact same
claims about over-warning and drug company economic distress 6
years ago when the Supreme Court decided in Wyeth v. Levine
cases. The Court ruled that the FDA regulation did not shield
drug manufacturers from state failure-to-warn tort liability,
but since then, we have not seen any of these dire predictions
come to pass.
When we enacted the Hatch-Waxman bill in 1984, we did not
give generic drug companies immunity from liability. In fact,
the industry did not get immunity until 2011 when this Pliva
case was decided. The tremendous growth of generic drugs from
'84 to 2011 proved that the generic drug industry can flourish
without immunity from state liability.
The one issue for which I do have some limited sympathy is
that of sameness. Sameness is fundamental to Hatch-Waxman.
Generic drugs are the same as their brand counterparts. They
are proved based on demonstration that they are chemically the
same and have the same effects in the body. And because they
are the same, they are required to have the same labeling as
the brand at the time of approval.
It is also important that the labels remain the same
thereafter. But this does not mean that there can be no
differences. There can be differences for brief periods of time
when labeling updates need to be made, just as there can be
because of differences in inactive ingredients or indications.
In fact, the existing regulatory policy under which brands may
update their safety labeling without waiting for FDA approval
also results in temporary differences between the brand and
generic label. These temporary differences occur during the
time between when the brand makes its label change and the time
when FDA approves it and then the generic manufacturer actually
makes conforming changes. Few would argue that the current
process violates the sameness requirements.
FDA has tried in its proposal to minimize these differences
to the extent possible. Experience will tell us whether the
mechanics of the process FDA has proposed will need to be
improved. If refinements are needed, I hope the FDA will make
them. But I applaud FDA for releasing this proposal now and
urge the agency to finalize it quickly after reviewing and
taking into account all the comments. I believe the rule will
result in even greater consumer trust and confidence in the
generic industry, trust and confidence that I am very proud to
share.
I thank the chairman for holding this hearing. I look
forward to the testimony of the witnesses. I yield back the
time.
Mr. Pitts. The chair thanks the gentleman.
All the other members' opening statements will be made part
of the record.
[The prepared statement of Mr. Upton follows:]
Prepared statement of Hon. Fred Upton
In a bicameral letter sent earlier this year, my colleagues
and I raised important questions and concerns regarding the
Food and Drug Administration's recent proposed rule on generic
drug labeling, and today I hope we can learn more about the
agency's rationale. There are significant concerns regarding
the legal basis for the proposed rule and its consequences on
patients and providers.
First, there is the question of whether FDA has the
authority to even make this proposal. Since the passage of the
Hatch-Waxman Act three decades ago, the agency has adamantly
asserted that a generic drug must have the same labeling as the
brand-name product and that this ongoing requirement is based
in statute. In 2011, the Supreme Court agreed. With this
proposed rule, FDA is taking a different view of the statute.
If the law does actually need to be changed for whatever
reason, the authority to do so belongs to Congress.
Second, we want to find out why the FDA proposed this rule
and who was involved in the decision-making process. FDA stated
in the proposal that the generic market has matured and that
manufacturers no longer have sufficient incentives to conduct
post-market surveillance, evaluation, and reporting. They cited
the need to get new safety-related information to patients
faster and that allowing generic companies to change their
labeling prior to FDA-approval would ensure that such companies
actively participated in the process. Yet in their response to
our letter from January, FDA cited no evidence that generics
are not actively participating already and no evidence that
there are public health concerns justifying such a fundamental
shift in well-established policy. The agency made very
contradictory statements in its brief to the Supreme Court just
three years ago. What changed?
Finally, and most importantly, we need to understand how
this proposal would impact patients and providers both in terms
of confusing warnings and raising the costs of generic drugs.
Generic drugmakers like Perrigo in southwest Michigan provide
medicines that countless Americans depend on. In fact, more
than 80 percent of prescriptions are currently filled with
generic drugs. But the FDA's proposed rule could drive the
costs up for the drug manufacturers, patients, and the
government.
Simply, this proposed rule reverses years of successful
practice and is built on questionable legal terms.
I look forward to hearing from FDA and understanding the
need for and rationale behind this proposed rule. I yield the
remainder of my time to ----------------------------.
Mr. Pitts. We have two panels before us today, and on our
first panel we have Dr. Janet Woodcock, Director of the Center
for Drug Evaluation and Research, U.S. Food and Drug
Administration.
Thank you for coming today, Dr. Woodcock. Your written
testimony will be made part of the record and you will have 5
minutes to summarize your testimony.
So at this time, the chair recognizes Dr. Woodcock for 5
minutes for an opening statement.
STATEMENT OF JANET WOODCOCK, M.D., DIRECTOR, CENTER FOR DRUG
EVALUATION AND RESEARCH, U.S. FOOD AND DRUG ADMINISTRATION
Dr. Woodcock. Thank you, Mr. Chairman, and members of the
subcommittee.
I am Janet Woodcock, Director of the FDA's Center for Drug
Evaluation and Research. And I appreciate the opportunity to
testify.
I am happy to discuss FDA's proposed rule that would
provide generic drug makers with the same opportunity as brand
drug makers to update their labels when they have new safety
information. They would also be able to distribute the revised
label before FDA reviewed it by submitting a Changes Being
Effected supplement. It is known as a CBE supplement. This
would be dissemination of new drug safety information to health
professionals and patients.
Now, this is a proposed rule. The comment period closed
about 2 weeks ago and we are now reviewing comments. While I am
free to discuss the proposal, I am not able to discuss what we
may or may not do further.
FDA-approved generic drugs are copies of brand drugs. They
have the same safety and effectiveness as brand drugs for their
approved indications. They are held to the same quality
standards as brand drugs, and generic drug makers right now
have the same obligation to monitor their drug safety as the
brand drug makers do. But currently, only the brand drug makers
can update their label with new safety information and
distribute the revised label before FDA reviews the change.
They do this by submitting a CBE supplement. Generic drug
makers must wait to change their labels until the FDA approves
the brand name change.
In today's world when over 80 percent of all U S.
prescription drugs dispensed are generics and brand drug makers
may drop out of the market after generics are approved, FDA
believes it is time to provide generic drug makers with the
means to promptly update their labels. In fact, for over 400
drugs, the only marketed drugs are generics and we expect that
this number will increase over time.
The proposed rule, if finalized, would allow the generic
drug makers to use the same process that brand drug makers use
to update their safety information. It would ensure that all
manufacturers marketing the drug, other generics as well as the
brand, would be promptly advised of the new safety information.
And we also propose to establish a dedicated web page where
FDA would post information about these proposed changes
submitted in CBE supplements for all drug and biological
products so that healthcare providers and patients could have
access to this information while FDA is reviewing it.
FDA would make an approval decision on the proposed change
for the generic drug and the corresponding brand drug at the
same time so that after FDA approved a change, the brand and
generic drugs would all have the same FDA-approved label. After
FDA approves a label change for the brand drug, the proposed
rule would set up a 30-day time frame in which the generic drug
makers would submit conforming changes to their label. Right
now, the situation is FDA currently advises generic drug makers
to update their drug labels at the very earliest time possible
after a change to the innovator, and the time in which they
actually do update that varies quite a bit.
So in light of that range of time frames where generic drug
makers currently submit supplements, the proposed procedures
would likely minimize the current variation between brand and
generic labels that is in existence right now and would cause I
think less confusion because there are no time frames
stipulated by FDA and there are often considerable delays
before all the generic drug labels are dated. Therefore, any
confusion that might be caused by different labels would be
reduced by this proposal.
In conclusion, I want to emphasize that this proposed rule,
if finalized, is intended to improve the communication of
important drug safety information to both prescribers and
patients.
Thank you and I look forward to answering questions.
[The prepared statement of Dr. Woodcock follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Pitts. The chair thanks the gentlelady and I will begin
the questioning and recognize myself 5 minutes for that
purpose.
Dr. Woodcock, in 2011 in a brief submitted to the Supreme
Court in Pliva v. Mensing, FDA argued on the merits, and both
the majority and dissenting opinions agreed that a generic
manufacturer could not unilaterally change its labeling without
violating the plain language of Hatch-Waxman. FDA has taken
this position for more than 20 years over the course of various
administrations.
FDA argued in the 2011 brief that generics do however have
a duty to provide adequate warnings and that they discharged
this duty by promptly contacting the agency about new safety
information so that FDA can make an informed decision about any
labeling changes the agency determines are warranted.
Without citing any evidence in the proposed rule or in the
agency's response to the bicameral letter we sent in January,
FDA now speculates that generic companies will stop meeting
their post-market requirements under the law. Despite all their
previous assertions to the contrary and despite the fact that
they took the exact opposite position in 2011, FDA is now
claiming that the Hatch-Waxman Act does not in fact preclude a
generic company from unilaterally changing their labeling to
strengthen warnings, that they should now be able to do so
because the market has matured.
Dr. Woodcock, the market has not matured all that much
since 2011. What really prompted the FDA's decision to
fundamentally change its position on these matters and what
role did plaintiffs' lawyers play in the process?
Dr. Woodcock. What prompted FDA to look into this rule was
partly by the court ruling that pointed out a disparity in the
obligations between the generics and the innovator drugs. And
in today's world, a world where the generics are more than 80
percent of all prescriptions dispensed to patients in this
country, we feel the standards should be the same, the
standards for manufacturing, the standards for safety and
efficacy, the standards for overseeing safety, and the
standards for reporting to FDA. So we wanted to have a level
playing field, have the same standards, and correct this
inconsistency.
Mr. Pitts. Now, in February of 2013 while FDA was drafting
this proposed rule, agency officials met with several
plaintiffs' lawyers, including at least one representative from
the American Association for Justice, also known as the
Association of Trial Lawyers of America. In fact, according to
FDA's public calendar, one of the agency participants in this
meeting was Daniel Siegelman from the office of the
Commissioner, who is himself a former prominent member of trial
bar. Would you please provide the Committee with the minutes
from this February 2013 meeting?
Dr. Woodcock. We will get back to you with what we have.
Mr. Pitts. Would you commit to working with the Committee
to provide any other communications between agency officials,
including Mr. Siegelman and representatives of the American
Association for Justice relating to the proposed rule or other
approaches that were considered?
Dr. Woodcock. Certainly.
Mr. Pitts. Now, I am going to read a statement from a
separate brief submitted to the Supreme Court by Ranking Member
Waxman and ask you to comment. ``It is clear that a generic and
a brand name label must be the same and that a generic firm
cannot unilaterally change its label. To permit individual
generic drug labels to differ significantly from their brand
name counterparts, particularly with respect to safety
information, would thwart the sameness goal reflected in the
Hatch-Waxman amendments.'' Dr. Woodcock, did the agency agree
with this statement in 2011 and does the agency agree with this
statement today?
Dr. Woodcock. All right. Certainly with all due respect to
Mr. Waxman, who has obviously authored the legislation, I would
like to dispel the notion that the labels are the same now with
respect to safety information.
We have looked at this and it is not just the CBE-0, but
when we, say, do a class labeling, say, for the NSAIDs, we put
a box warning in, some major safety change is put into drug
labels, there is a time frame that can be considerable under
which the generics submit conforming labeling. And during that
time frame, those labels are different.
And in fact, I would submit to you from a practical point
of view as I administer the program, these drug labels are
dynamic and may change up to maybe 10 years, 15 years. I think
our latest is 38 years after a drug has been on the market, we
are still discovering safety information. That needs to get
onto the label as quickly as possible. The generic copies may
take quite a long time, months, perhaps a year or so before
they make conforming changes to their label. And then of course
that takes much longer to get out there in circulation because
the print nature of the package insert.
So, while in principle they are the same, because of the
dynamic nature, they are not literally and exactly the same
right now. And the proposed rule, if it were enacted, would
actually narrow down that time, that disparity, that temporary
difference. And after FDA would approve, maybe we would not put
the safety label in or maybe we would decide that the safety
update goes on a drug label, then all the manufacturers of that
drug would have to change and the generics would have 30 days
in which to do that.
Mr. Pitts. The chair thanks the gentlelady and now
recognizes the ranking member, Mr. Pallone, 5 minutes for
questions.
Mr. Pallone. Thank you, Mr. Chairman.
Dr. Woodcock, Mr. Neas, who is here today representing the
generic drug makers, argues that FDA should focus on assuring
patient safety and not on preemption of state tort law. I agree
with the FDA that state tort law complements FDA oversight and
enhances patient safety. My reading of the FDA proposed rule is
that its primary purpose is to realign FDA post-market safety
monitoring and labeling requirements with the realities of the
current marketplace and increase the speed at which new drug
safety information gets to doctors and patients.
So I just wanted to ask you initially is that a fair
reading of the purpose of the proposed rule and if you wanted
to comment on that?
Dr. Woodcock. That is correct. With over 80 percent, as we
have all said, of drugs taken by Americans today being generic
drugs and many of the generic drugs not having an innovator
copy on the market, the goal is to make sure that the whole
system is searching for safety problems and promptly updating
labels when they are found.
Mr. Pallone. So another criticism made by Mr. Neas is that
requiring generic manufacturers to make unilateral labeling
changes will lead to a flood of unnecessary and different
labeling changes and confuse doctors and patients. And he also
claims that companies will exaggerate the risks of their drugs
leaving patients to avoid taking needed medications.
I know that in the lead up to the Wyeth vs. Levine case,
brand drug companies made similar predictions of over-warning
if the Supreme Court were to rule again preemption, as it did.
So I guess, couple things. First, has FDA found that drug
companies commonly over-warn?
Dr. Woodcock. Well, we have existing precautions against
that. Our regulations that we passed a few years ago called the
physician labeling rule, which modernized the drug package
insert, has specific caveats about doing such things and
requires certain levels of evidence before you just put
warnings in the label. Many of you may not have looked at a
drug label, but long ago, they were what we called the laundry
list. There were just long lists of things that might happen to
you. And the modern drug label has eliminated much of that
because it is not informative.
Mr. Pallone. Did the FDA see a worrisome increase in over-
warning after Wyeth v. Levine?
Dr. Woodcock. Not to my knowledge.
Mr. Pallone. And the FDA believes that this concern about
the over-warning, do you think that is warranted?
Dr. Woodcock. I think it is important to stress that these
warnings are temporary. They are put up there because something
has been discovered and the company feels there is a reasonable
link to the drug. Then after that occurs, right now with the
innovator, we take a look at that and we gather up whatever
evidence there might be and we may have studies or other things
that are brought to bear. And then FDA makes a decision about
whether that is actually going to be approved FDA labeling or
not. And the same would be true here with this proposal.
Mr. Pallone. All right. Let me ask you about the Mensing
decision. Were generic drug companies subject to failure-to-
warn liability before Mensing?
Dr. Woodcock. Well, first of all, may I remind everyone I
am not a lawyer; I am a physician. But I understand that for
many years prior to the Mensing decision, the generic drug
manufacturers were generally considered to be potentially
liable for failing to warn of important drug safety
information. And during that time, they grew to about 75
percent of the U.S. retail prescription market. In other words,
the industry thrived during that time.
Mr. Pallone. So is it fair to assume that finalizing the
FDA rule essentially will bring the generic industry's
liability situation back to something similar to what they
faced before the Mensing decision in 2011?
Dr. Woodcock. I think that is a reasonable assumption that
I would again argue that I am not very qualified to opine on
that.
Mr. Pallone. I mean because we have all heard that--well, I
guess the GPhA commissioned a study looking into the economic
impact of the FDA rule, and it concluded that finalizing the
FDA rule will lead to new liability protection costs for the
generic drug industry of about $4 billion a year, and yet the
cost attributable to the FDA rule sound like they may be, you
know, really not different from the liability cost the industry
faced prior to Mensing. So, I don't. I am questioning the value
of the study. You don't have any comment?
Dr. Woodcock. It requires a lot of assumptions to make
those conclusions.
Mr. Pallone. All right. Thank you, Mr. Chairman.
Mr. Pitts. The chair thanks the gentleman and now
recognizes the gentleman from Florida, Mr. Bilirakis, 5 minutes
for questions.
Mr. Bilirakis. Thank you, Mr. Chairman. Thank you, Dr.
Woodcock. I appreciate it very much. Thanks for your testimony.
First question, depending on the drug, there could be a
dozen generic products for the same brand drug. From a public
health stand point, don't you believe that the multiple
different versions of labeling will lead to confusion among
doctors?
Dr. Woodcock. Well, in fact, the state is now when FDA
makes a label change to the innovator, there will be multiple
different versions because the generic drugs will be changing.
We have seen the drug makers will change their label over a
period of time. Some would change their label to conform very
rapidly; others may take a year or so. So that is the current
situation.
Mr. Bilirakis. OK. Next question: the FDA frequently issues
guidance documents better informing industry of FDA's
expectations. How many guidance documents has FDA issued
related to updating of generic drug labeling in the past
decade? Can you give me that information?
Dr. Woodcock. I can't but I could get back to you on it.
Mr. Bilirakis. Please do.
Isn't it true that the FDA currently has the regulatory
authority to set specific time frames within which a generic
company must update their labeling to conform to the brand name
equivalent, and doesn't FDA have the authority to take
regulatory action against any company that doesn't comply with
the agency's requirements?
Dr. Woodcock. For the second part of your question, do we
have the ability to take action? Yes, I believe we do. And for
the first part of your question, that is part of this rule. The
proposed rule stipulates a time frame in which the generics
would have to conform. So we do have that ability. We show that
by proposing this rule.
Mr. Bilirakis. OK. If FDA feels as though it is not getting
adequate post-market safety information from companies----
Dr. Woodcock. Yes.
Mr. Bilirakis [continuing]. As required under the law,
isn't it the agency's responsibility to better enforce these
requirements to ensure that it does?
Dr. Woodcock. Well, I think that is a more complicated
question. It is a very complicated question. This proposed rule
is about giving companies the ability to rapidly change their
label and communicate information that they have found, all
right. Generic drug companies do not frequently submit new
safety information to the FDA.
What we usually audit companies for is their required
apparatus that they have to monitor for safety and to report to
us to make sure that they operate those functions. For example,
for a generic drug where there was no innovator on the market
anymore, we would really like to know that the generic drug
companies were out there watching and seeing what is happening
with their drug and telling us if they come across any new
safety problems.
Mr. Bilirakis. OK. Thank you.
I yield back, Mr. Chairman. Thank you.
Mr. Pitts. The chair thanks the gentleman and now yields to
the ranking member of the full committee, Mr. Waxman, 5 minutes
for questions.
Mr. Waxman. Thank you, Mr. Chairman.
I feel like I am in a Woody Allen movie when they asked
about Marshall McLuhan and the man in the back of the line said
I am Marshall McLuhan and everything you said is absolutely
wrong. Well, I am Henry Waxman from the Hatch-Waxman and I am
here to set the record straight.
I submitted a brief to the Supreme Court and I stated
generic and brand name labels must be the same because, after
all, the generic drug has to be the same as the brand name drug
so the warning labels have to be the same. But that was in the
context of the existing FDA regulation that said the brand name
companies could change their label if they know something more
that they ought to tell the consumer, but the generic companies
could not change their label and they couldn't act
unilaterally.
So I was making the point that even within that context,
generic manufacturers should be subject to the state failure-
to-warn tort liability. That was my argument. The Court didn't
accept it. The Court said you have FDA regulations and what we
were arguing was not consistent with them. Now you are
proposing a new regulation.
My amicus also contained the statement that to permit
generic labels to differ significantly from their brand
counterparts, particularly with respect to safety information,
would thwart the sameness goal reflected by the Hatch-Waxman
Act. So I still believe that to be true. However, I don't think
allowing a temporary period of time in which the labels may be
different thwarts the sameness goals.
For example, you have existing regulations called CBE-0,
and that allows the brand name company, when they learn some
problem, to change their label even if FDA doesn't approve it.
FDA may later approve it. They have to send it to FDA, but they
can act on their own unilaterally. That would mean the warning
label would be different than on the generic drug, isn't that
right, Dr. Woodcock?
Dr. Woodcock. That is correct. And also the generics may
take various amounts of time even when FDA has approved a label
change to conform their own label.
Mr. Waxman. So we have a period in time I would like to be
kept at a minimum before the labels are the same but there is a
difference in time, and no one would argue that that violates
the Hatch-Waxman Act.
Dr. Woodcock. Yes.
Mr. Waxman. Sameness in labeling is important but also
finding out about new problems is important. You mentioned an
example to Mr. Bilirakis. What if the generic was based on a
brand that is no longer on the market?
Dr. Woodcock. Yes.
Mr. Waxman. Would we prohibit a generic that learns about
problems from doing anything to warn the public about these
problems? I think that was one of the issues that you had in
mind in proposing this new regulation, isn't that right?
Dr. Woodcock. That is correct. And increasingly, the
innovator companies are concentrating on innovation----
Mr. Waxman. Yes.
Dr. Woodcock [continuing]. And dropping their drug or
withdrawing it from the market or even withdrawing their
application after the drug goes generic because they can't
compete or they don't want to compete in that space.
Mr. Waxman. Yes.
Dr. Woodcock. And so there the generics are responsible.
They must stand behind that drug because there is no one else
watching the safety of that medication other than, of course,
the FDA.
Mr. Waxman. The FDA but the generic manufacturers which may
be the only manufacturers of the drug are more likely to hear
about the problems for which they need to warn the public and
hopefully they will give that to FDA. But they are the ones
that are making the drug that could be harmful unless people
understand the warnings that should go with it, isn't that
right?
Dr. Woodcock. That is correct. And most of the reports we
get--we get about 1 million reports a year about drug safety
problems and about 80 percent of those are from the
manufacturers.
Mr. Waxman. Yes. OK.
So I think there needs to be sameness in labeling. I think
that is critical, but equally important is ensuring the
patients know they will have the same right to access courts
whether they are injured by taking a generic drug as they would
if they took a brand drug. We don't want to scare consumers to
think, oh, if I take a generic, I may be taking something that
is not as safe. That has always been the brand name industry's
claim, that it is not the same; it is not as safe. But of
course if they are the same and the warnings are the same, then
the consumers should relax. And we want to get to that same
labeling.
Mr. Neas and Mr. Shumsky claimed that the proposed rule
fundamentally violates the sameness principle and that it
undermines the statutory and regulatory framework for approving
and overseeing generic drugs. How do you respond to that, Dr.
Woodcock? There are differences that occur now between brand
and generics. When brands use their existing CBE-0 process to
update their safety labeling, what you would be doing is giving
the generic that same opportunity. Do you think that this is
going to mean that we are going to have less sameness in drug
labeling?
Dr. Woodcock. I believe the portions of the rule that call
for the webpage and then call for all the labels to be
conformed within 30 days will result in less differences among
brand and generic labels in the future if this rule were to be
made final.
Mr. Waxman. That is a good objective.
Thank you, Mr. Chairman.
Mr. Pitts. The chair thanks the gentleman and now
recognizes the gentleman from New Jersey, Mr. Lance, 5 minutes
for questions.
Mr. Lance. Thank you, Mr. Chairman. And good afternoon, Dr.
Woodcock.
This is a very complicated topic. As I understand the
recent Supreme Court decisions, there is a question legally as
to whether the proposed rule complies with those decisions. I
certainly want the public to be as safe as possible, and at the
same time, I don't want the public to be confused. Do you see
any potential of a conflict between safety, which we all
desire, and confusion among the public on this issue?
Dr. Woodcock. Well, as we have been talking about a little
bit, I believe if the proposed rule were implemented, it would
reduce confusion caused by differing labels because there would
be more conformity of labels.
Mr. Lance. As I read the underlying statute, it appears to
me to be clear and it is my own opinion that what is proposed
may go beyond what is currently in the underlying statute. And
obviously, agencies try to administer underlying statutory law
to the best of your ability given your responsibilities in the
executive branch. Would it have been better for the agency to
come to us here to Congress to ask for an amendment if you
thought that you needed to move forward in the way you are
apparently moving forward?
Dr. Woodcock. It is hard for me to speculate on that. I am
not a lawyer. I would say that----
Mr. Lance. That speaks well of you. Some of us are lawyers.
Dr. Woodcock. Well, I don't, opine as a lawyer. I am not
one. However, I will say that we have been administering this
program a long time. The generic drug labels are actually
different in many areas, some of which have been stipulated by
Congress. For example, pediatric----
Mr. Lance. Yes.
Dr. Woodcock [continuing]. Exclusivity and et cetera, et
cetera. And they are different in their safety information due
to the time frame often it takes and due to the fact that the
generic industry does not often update their label in a timely
manner.
Mr. Lance. Thank you. I would hope that on issues like this
the executive branch and the legislative branch could work
together and often where you stand on an important issue of
public policy is based upon where you sit and sitting in the
legislative branch of government and having reviewed the
underlying statute and certainly having a great respect for
those who wrote the statute, including Mr. Waxman, I tend to
view the opinion of Mr. Shumsky and others as how I would read
the underlying statute. I realize it is extremely complicated.
But I would prefer if the executive branch and the various
agencies might come to us if an amendment would clarify the
situation and certainly statutory law from my perspective
serving in the Congress is the bedrock by which agencies
proceed, recognizing as I do that the safety and health of the
American people is preeminent.
Thank you, Mr. Chairman, and I yield back the balance of my
time.
Mr. Pitts. The chair thanks the gentleman and at this time
recognizes the gentlelady from Virgin Islands, Dr. Christensen,
for 5 minutes for questions.
Mrs. Christensen. Thank you, Mr. Chairman. Welcome back,
Dr. Woodcock.
Dr. Woodcock, FDA describes both the existing and the
proposed CBE-0 processes as an exercise of enforcement
discretion, and that sounds like either the agency is
deliberately flouting the will of Congress or the law is so
badly written that FDA can only make it work by ignoring parts
of it. Yet I know that FDA uses enforcement discretion in many
areas of regulation with good effect.
Could you put your use of enforcement discretion in the CBE
regulations into context? Could you explain how the agency uses
it elsewhere and its oversight of drugs or other FDA-related
products and why you have chosen to use it in this instance to
allow drug manufacturers to rapidly update their safety
information?
Dr. Woodcock. Well, first of all, I understand that
originally when the CBE-0 regs were written, that was how it
was described a long time ago. Maybe I was in high school. But
I think that what I understand from our lawyers now is that we
regard this as--the statute of course sets the framework, as
has just been pointed out, that regulations are implementing of
that framework. We regard this as implementing, interpreting
part of the statute. So I am not sure we regard this in today's
legal world as enforcement discretion.
But we do use enforcement discretion in many areas. For
example, one of the most poignant is probably our dealing with
the shortage issues where we are getting products from around
the world for critical medical needs that are being not met for
our population. After we verify that they are correctly
manufactured and of high quality, we will have them imported
into the United States.
Mrs. Christensen. Thank you. Well, whether it is
enforcement or not, I think the whole process seems consistent
with one of the overriding purposes of the food and drug law,
to protect patient safety.
Also in his testimony, Mr. Neas notes that generic
manufacturers only have access to information about their
individual products saying that FDA is the only entity with
access to all safety information and is the only body in a
position to decide whether a labeling change is warranted. How
do you respond to those points?
Dr. Woodcock. Well, what we are talking about here is sort
of early notification. That can be done now by the innovator to
change their label in advance of an FDA decision. And what we
are proposing is that the generic industry should be able to
change their label in advance of an FDA decision. After we get
a safety signal and, we may evaluate it through our Sentinel
system, we may do a literature search, seek data from other
sources, and generally deliberate and finally make a final
decision. You know, should this be a box warning? Should it be
a precaution? Is it a contraindication or is it just another
warning? Or maybe, as was raised earlier, it isn't adequately
linked and should not be on the label.
Mrs. Christensen. Yes.
Dr. Woodcock. Once we make that decision, we then are
proposing here that we tell everyone all at once you should
change your label to conform to the FDA decision.
So, yes, FDA would weigh in at the end of the day on this
but what we will do now, and as a clinician you are aware of
this, and it is frustrating somewhat but FDA will put out
safety information that says we are looking at this.
Mrs. Christensen. Yes.
Dr. Woodcock. We just don't know what it means yet. But
people became very unhappy that we weren't notifying them that
we were evaluating this issue, so if it is an important safety
issue, we actually put out a drug safety alert and say we are
evaluating this. We don't know what the truth is yet, but we
will keep you informed and let you know when we have made a
decision.
Mrs. Christensen. Thank you. And I agree basically. And as
the proposal notes, not only do generic drugs now comprise over
80 percent of drugs sold but they constitute 94 percent of the
market for those drugs for which generics are available. So
many of them may not have a preponderance on the market. Some
are likely to have much more than the brand. And as the rule
makes clear, FDA continues to reserve for itself the final
decision regarding proper labeling.
Thank you, Dr. Woodcock.
Dr. Woodcock. Thank you.
Mr. Pitts. The gentlelady yields back.
The chair recognizes the gentleman from Illinois, Mr.
Shimkus, for 5 minutes for questions.
Mr. Shimkus. Thank you, Mr. Chairman. Welcome, Dr.
Woodcock. Good to see you again.
In proposing significant changes to prescription drug
labeling requirements in December 2000, FDA, under the Clinton
Administration, found ``the use of labeling and product
liability and medical malpractice lawsuits, together with
increasing litigation cost has caused manufacturers to become
more cautious and include virtually all known adverse event
information regardless of its importance or plausibility
relationship to the drug.'' Do you agree with this statement or
is this no longer a concern of the agency?
Dr. Woodcock. That was the practitioners' labeling rule,
the label modernization that you are talking about. And in
there we put in some standards that prevent putting in the
label events that are not really causally linked where we don't
see a causal association. So we were basically putting people
on notice that we did not think that those types of events,
that laundry list, should get into a drug label. And the
modernized drug labels do not have that feature.
Mr. Shimkus. So it is no longer a concern of the agency?
Dr. Woodcock. It is always a concern but we have put in
safeguards to make sure the modernized labels----
Mr. Shimkus. OK.
Dr. Woodcock [continuing]. Don't contain that.
Mr. Shimkus. All right. Before proposing the 2000 rule, the
FDA held multiple focus groups and conducted a national survey
of healthcare providers. Prior to issuing the proposed rule in
November of 2013, did the FDA discuss these changes with
physicians?
Dr. Woodcock. Yes. Well, the physicians were part of the
focus groups. We had a public----
Mr. Shimkus. No, I am talking about this current rule that
you are proposing.
Dr. Woodcock. Oh, this one. Oh, I am sorry. No.
Mr. Shimkus. Did the FDA meet with any pharmacists to hear
their thoughts?
Dr. Woodcock. No, not to my knowledge.
Mr. Shimkus. Did you meet with any of the branded drug
companies?
Dr. Woodcock. Not to my knowledge.
Mr. Shimkus. What about the generic drug companies?
Dr. Woodcock. Not to my knowledge. I did not.
Mr. Shimkus. Did the FDA meet with the trial lawyers?
Dr. Woodcock. My understanding is that this is the case.
However----
Mr. Shimkus. So in 2000 you met with all these groups?
Dr. Woodcock. That is correct.
Mr. Shimkus. So you didn't meet with physicians, you didn't
meet with pharmacists, you didn't meet with branded drug
companies, you did not meet with generic drug companies, but
you met with the trial lawyers?
Dr. Woodcock. Well, after the----
Mr. Shimkus. I think you have already testified it is yes.
Dr. Woodcock. After the court decision I sat down with the
staff at the Center for Drug Evaluation and Research and we
went over options for dealing with this disparity in the
treatment of the two groups. And we went ahead and drafted this
rule. I was not aware----
Mr. Shimkus. So let me get back. So the answer is yes?
Dr. Woodcock. My understanding is----
Mr. Shimkus. You can just say it. Come on. Get it out.
Dr. Woodcock. Part of the agency did meet with the trial
lawyers, yes.
Mr. Shimkus. Thank you. Because in your responses earlier,
you talked about how innovator drugs, right----
Dr. Woodcock. Yes.
Mr. Shimkus [continuing]. Who may not be in the market
anymore and you have the generic drug----
Dr. Woodcock. Yes.
Mr. Shimkus [continuing]. But it is funny you are using
that as an explanation but you didn't discuss this with
innovator drugs and you didn't discuss this change with the
generics. So even in your answers to our questions today, you
are using what you would think would be support from and
inclusive process of an evaluation of a new rule without
talking to these two groups.
So let me ask you this question. What role did the trial
lawyers play in complying in the development of this new rule?
Dr. Woodcock. To my knowledge, none, because, as I said----
Mr. Shimkus. Wait, wait. You met with them, you changed the
rule, and you are saying they had no role in developing this
new rule?
Dr. Woodcock. Right. I was trying to explain that.
Mr. Shimkus. I know. I am trying to believe it.
Dr. Woodcock. Well, I am explaining factually what
happened, all right. The Center for Drugs, I asked our staff
here at the Center for Drugs to look at this finding which
pointed out we did not have a level playing field of sameness
between the innovators and the generic drug firms. They
developed a list of options. We picked the option we wanted to
pursue and it was really a matter of feasibility and execution
and we developed that rule. The personnel in the Center for
Drugs did not meet with the trial lawyers----
Mr. Shimkus. And you understand why we have questions about
this rule if you met with just the trial lawyers and you didn't
meet with any of the folks that are involved in this sector?
Dr. Woodcock. Certainly.
Mr. Shimkus. All right. Thank you. I yield back my time.
Mr. Pitts. The chair thanks----
Mr. Waxman. Mr. Chairman, I ask unanimous consent that the
gentleman be given an additional minute so I can ask him to
yield to me.
Mr. Pitts. Do you want to have me recognize Mr. Sarbanes?
Mr. Shimkus. No, the ranking member is asking for unanimous
consent for me to be given another additional minute so I can
then yield to the ranking member.
Mr. Pitts. All right. The chair recognizes the gentleman
for one minute.
Mr. Shimkus. I would be happy to. And I would then yield to
Mr. Waxman.
Mr. Waxman. Whoever you met with before is interesting but
don't you now have to have comments from everybody with a
proposed rule and take those comments into consideration?
Dr. Woodcock. Certainly. The folks we met with before were
about parts of the label that would really impact them and this
is more of a procedural issue. But we put together a procedure.
We instantiated it in this proposed rule and we have received
over 100 comments from a wide range of groups and we will be
evaluating those comments.
Mr. Waxman. Thank you.
Mr. Shimkus. And reclaiming the rest of the minute, I
understand that now you are going to receive comments. However,
historically, you met with everyone involved in this sector.
You now issue a new proposed rule with only meeting with the
trial lawyers. I think that raises cause of concern and the
reason why many of these questions are going to for what
purpose and there is a question on intent.
And I yield back my time.
Mr. Pitts. The chair thanks the gentleman and now
recognizes the gentleman from Maryland, Mr. Sarbanes, for 5
minutes for questions.
Mr. Sarbanes. Thank you, Mr. Chairman. Thank you, Dr.
Woodcock. You are one of the best witnesses we get up here and
I appreciate your testimony.
I am sort of baffled at what the objection could be to the
proposed rule and looking forward to the second panel to
elucidate that for me. It seems eminently reasonable what you
are trying to do. I think that it strikes exactly the right
balance that we would want to see between the objectives,
aspirations, and the success of the Hatch-Waxman Act and then
having to deal with practical obstacles that that framework
encounters over time. So it makes a lot of sense what is being
proposed.
And Congressman Waxman got right to the point I was going
to make which is I gather now that comments have been in as of
2 weeks ago, right?
Dr. Woodcock. Yes.
Mr. Sarbanes. And those include a lot of perspective from
consumer groups out there, people that are concerned about
safety issues, presumably, isn't that the case?
Dr. Woodcock. Yes, there are comments from consumers,
consumer groups.
Mr. Sarbanes. It seems to me this notion that if a trial
lawyer has a positive opinion of the proposal, that somehow
that should taint, undermine, or eliminate the concerns that
the broad public has about seeing this kind of proposal. In
fact, my view would be that they are largely reflecting the
opinions and perspective of the broad public and those people
who could be potentially damaged if you don't have a proper
framework in place. So it is good to hear that those comments
include organizations that would represent that kind of
perspective on safety. And we look forward to seeing how the
rule will roll out from here.
I was curious before the Mensing case, before this decision
that appeared to protect or did protect the generic
manufacturers from failure-to-warn cases at the state level,
which was only a couple of years ago. Before that, as industry
was developing, presumably they were getting more engaged in
monitoring based on the exposure and liability that they
properly had vis-a-vis the public and consumers. Would that be
accurate to say?
Dr. Woodcock. Yes. And as far as sameness, they have the
same requirements for monitoring the recipients of their drug
or any reports that they get of problems with their drug and
reporting those to the FDA so that is the same as for the
innovator industry.
Mr. Sarbanes. You mentioned that you think probably there
are some assumptions and the projection that this will result
in a $4 billion hit to the generic drug industry as a result of
having this liability there. I will be interested to hear
testimony that backs those kinds of assumptions up because I am
skeptical of them, as I think you are, and certainly
Congressman Waxman has indicated his skepticism about that.
I am a very intrigued by your testimony that not only does
the proposed rule not add to the sameness problem----
Dr. Woodcock. Yes.
Mr. Sarbanes [continuing]. That has been discussed but in
fact it would help to remedy----
Dr. Woodcock. Yes.
Mr. Sarbanes [continuing]. Some of the problems that there
has been with sameness because there hasn't been in place the
kind of timelines that would push the generic manufacturers to
come in to conformity on a more expedited basis.
Dr. Woodcock. That is correct.
Mr. Sarbanes. So you have sameness issues now that are kind
of initiated from the innovator brand side of the equation. You
may now get situations where the sameness, you know, that sort
of glitch gets initiated from the generic side. But all told,
what you are proposing, as I understand it, is a structure that
will lead to more sameness, to use that sort of odd phrase,
than less. And so that will be actually an improvement over the
current situation, is that correct?
Dr. Woodcock. That is correct. We would anticipate that the
amount of disparities between the generic label and innovator
label will decrease with this proposal because it will put in a
30-day clock for conformance to the labels.
Mr. Sarbanes. Terrific. Thank you very much, and I yield
back.
Mr. Pitts. The chair thanks the gentleman. Because we have
a just heard there may be some confusion over various views on
this proposed rule, let me take this time to request unanimous
consent to insert the following documents into the record: AARP
letter to Commissioner Hamburg dated March 13, 2014; ``The
FDA's Proposed Generic Drug Labeling Rule: An Economic
Assessment'' by Alex Brill, February 5, 2014; a letter from FDA
to Congressman Kevin Yoder, January 29, 2014; March 6, 2014,
letter from 24 members of the Pharmaceutical Supply Chain to
Commissioner Hamburg; of the labels on generics drugs, ``The
FDA Should Take the Lead on Making Drug Warning Labels
Consistent,'' LA Times, article, March 12, 2014; committee
letter to Commissioner Hamburg regarding the proposed change to
generic drug labeling policy dated January 22, 2014; and the
FDA's response dated February 26, 2014; a letter dated March
14, 2014, to Commissioner Hamburg from Minority Health Groups;
and finally, a letter dated March 13, 2014, to Commissioner
Hamburg from Patient Advocates.
Without objection, so ordered.
[The information appears at the conclusion of the hearing.]
Mr. Pitts. The chair now recognizes the gentleman from
Kentucky, Mr. Guthrie, 5 minutes for questions.
Mr. Guthrie. Thank you, Mr. Chairman.
Thank you for coming, Dr. Woodcock.
A lot of discussion on the topic of changes being effected
involves generic drugs. It occurs to me that CBE is also an
important policy issue in the context of biosimilars. What is
the current legal status of CBE with respect to biosimilars and
would the proposed rule change the current legal status of CBE
with respect to biosimilars? And I know that biosimilars,
though none have been approved by the FDA yet, but when they
are, will they have CBE or not?
Dr. Woodcock. This rule does not pertain to that because
those would be under the Public Health Service Act and they are
not considered generics like the generics are. So that is a
separate issue.
Mr. Guthrie. Completely separate, thank you.
In your testimony throughout the day, you stated four or
five times that this rule would address the need for outdated
generic labels to be updated. While that may be so, that was
not the basis for why the FDA issued the proposal. In fact, I
have been told that the goal was not even addressed in the
proposed rule. What is the agency's stated rationale for
proposing this rule change and if updating outdated generic
labels is really the goal, can't you address those
administratively or with better enforcement?
Dr. Woodcock. Well, the goal of this, at least my goal and
the Center for Drugs' goal was to update what we felt was a
disparate playing field for the brand industry and the generic
industry where the generic industry has really grown up to be
taking care of much of the healthcare of your constituents in
this country. The drugs they get at their pharmacy are generic
drugs. And so that was the goal from my point of view.
We are looking at updating old labels and this isn't just a
fault of the generic industry; it is a fault of the innovator
industry, too. Drug labels need to be modernized and the
modernization effort that was talked about earlier only went
back to, I think, 2003.
Mr. Guthrie. Yes.
Dr. Woodcock. And so we are looking at updating globally
the drug labels in general.
Mr. Guthrie. Is your FDA pilot project Sentinel, is that
focused on that? Is that what that is, the Sentinel system?
Dr. Woodcock. Sentinel system is using electronic health
records to learn and look at safety signals that we get. So
that is what Sentinel is about. We have electronic health
records of 150 million people and we can look in there and find
out what happens when they took a drug and find out whether a
side effect is real. We are doing a different pilot on
modernizing drug labels that have become out-of-date.
Mr. Guthrie. OK. And I have one last question. Ranking
Member Waxman discussed the brief he filed with the Supreme
Court in 2011. My understanding of that brief a different
approach than the one ultimately included in FDA's rule
proposed was raised. I believe the brief suggests that FDA
should formalize the process by which a generic manufacturer
could provide the FDA with any new information they obtained
regarding safety hazards associated with their products and
that they could be held liable if they failed to do so. Why
does the FDA feel that that was an inadequate approach and why
you have to go this direction?
Dr. Woodcock. I am sorry but I am unfamiliar with what
mechanism that they were supposed to update their labels.
Mr. Guthrie. Yes. I have a quote from the brief. ``Provide
the FDA with any new information they obtain regarding safety
hazards associated with their products.''
Dr. Woodcock. Yes, well, generics have always supposed to
have been able to do that. So this is simply a mechanism. This
is really a procedural rule that allows a procedure that was
always available to innovator to be made allowed to be
available to generics as well.
Mr. Guthrie. OK. Thank you. I yield back.
Mr. Pitts. The chair thanks the gentleman and now
recognizes the gentleman from Texas, Mr. Green, for 5 minutes
for questions.
Mr. Green. Thank you, Mr. Chairman. And I am glad you are
here, Dr. Woodcock.
I think the three main criticisms of the proposed rule is
that it would restore tort liability to generic manufacturers,
which I don't know if that was the intent but one criticism if
the proposed rule restores the tort liability, which critics
argue would lead to warning and significant higher generic drug
rates.
Two, the rule undermines the sameness principle that
generic and brand name drugs have to be the same, including
their labeling and therefore undermines the entire Hatch-Waxman
justification.
And three, the rule would lead to a multitude of different
labels confusing doctors and patients and undermining
confidence in generic drugs.
Frankly, I don't mind if somebody is producing a drug, they
ought to have some responsibility for it so I don't have that
big a concern about the tort liability. But the other two I do
have some concern about. It undermines the sameness principle
that Hatch-Waxman did and also the multitude of labeling.
Dr. Woodcock. Well, as I explained earlier, right now,
there are different versions of the label because the innovator
will change their label. Even after FDA approves that label, it
takes some time, for some cases a year, maybe 2 years for some
of the generics, not all of them, to change their label. So
there are differences out there between the innovator and
generic labels that are disparities now. And this proposal that
we have would reduce the time of confusion if you want to call
it confusion.
Mr. Green. OK. But then the sameness principle issue that
was brought up?
Dr. Woodcock. I feel that the sameness applies and if you
are a consumer or patient I think that you would want to know
that the drug is the same as far as its chemical composition,
as far as its pharmacology, and as far as the manufacturers
standing behind that drug, all right, and doing the safety
surveillance and the monitoring and keeping their label up-to-
date no matter whether they are innovator or a generic
manufacturer.
The sameness as a literal point of view that labels need to
be exactly the same, they are not exactly the same and there
are a number of reasons, for example, the pediatric
exclusivity, there may be certain constituents that are
slightly different that is allowed. There may be other
carveouts to the label due to new indications that the
innovator has that the generic doesn't have. And there are
these differences due to the safety changes in other label
updates that actually the generics don't necessarily update in
a timely manner.
Mr. Green. Well, Mr. Chairman, I think consumers actually
do look at labeling, too, not just physicians obviously, for
the prescription.
Dr. Woodcock. Yes.
Mr. Green. And I will give you an example. Zyrtec is
something that has been successful but now it has lost its
exclusivity and there is a generic available for it that I
noticed still has the same compounds as Zyrtec. So consumers
also look at it other than physicians.
And I yield back my time.
Mr. Pitts. The chair thanks the gentleman and now
recognizes the gentleman from Georgia, Dr. Gingrey, 5 minutes
for questions.
Mr. Gingrey. Mr. Chairman, thank you. And, Dr. Woodcock,
good to see you.
What is wrong with the current process that the FDA has
defended as being necessary to bring orderly change to the
labeling when it is warranted? What is wrong with the current--
--
Dr. Woodcock. As the universe has changed and time has
changed, the generic industry is now in charge of much of the
healthcare. It delivers most of the dispensed prescriptions in
the United States.
Mr. Gingrey. Well, I know the doctor from the Virgin
Islands mentioned that a little earlier, that maybe 85 percent
of the drugs that are dispensed today are generic. Is that what
you are getting at?
Dr. Woodcock. Yes. And, in fact, in that situation those
manufacturers who are marketing those drugs, they need to be
monitoring those drugs for safety. The people who market the
drugs will get the reports, all right?
Mr. Gingrey. Let me ask you this just a yes-or-no answer.
The approach the FDA now proposes will result in an orderly
process that gets evidence-based appropriately tailored
labeling changes to prescribers in the best possible manner.
Dr. Woodcock. Yes.
Mr. Gingrey. It does, right? In this proposed rule--and,
listen, I just came from another committee hearing where I was
praising the trial attorneys, but this proposed rule sure seems
to me to be led by the trial attorneys. I am following up on
what the gentleman from Illinois, Mr. Shimkus, said. And as a
physician like me, I hope that you would disagree with this
implication that the FDA trusts the trial bar to be the chief
stewards of public health policy.
Dr. Woodcock. The impetus behind this rule was to have a
level playing field in a situation where now the generic
manufacturers make most of the drugs that your constituents
take. And that they have the same opportunity to react to the
reports that they get of safety problems and rapidly modify the
labels and bring them to FDA's attention. There are about 420
drugs right now that have no innovator on the market and so it
will only be the generic manufacturers to whom those reports
would come or to the FDA directly.
Mr. Gingrey. Under the proposed rule, I understand that
generic innovator--now, innovator is the same as the brand----
Dr. Woodcock. Yes, sorry.
Mr. Gingrey [continuing]. The original drug that the
company brought. I understand that generic and innovator
companies could propose labeling changes through the CBE
process and that the agency would post all of these suggested
changes on your Web site on the FDA Web site before you would
approve them. That is correct, isn't it?
Dr. Woodcock. Yes.
Mr. Gingrey. And for multi-sourced drugs, those that are
the exact same, they are made by both the innovator and the
generic companies, isn't it possible that each manufacturer
could have different warnings posted for the same risk?
Dr. Woodcock. It is possible, but of course that would
enable us to move very quickly. We get these now from
innovators and they do a CBE-0 or we may hear from
practitioners, we may have it reported to us, we may get it
from the literature. We quickly evaluate those and we put out
an FDA drug safety alert. I am sure you are familiar with
these. Sometimes we say we are just looking at this issue. We
don't know the answer yet.
Mr. Gingrey. Yes.
Dr. Woodcock. So we are an actor in this as well but we
need to be made aware of what the manufacturers know.
Mr. Gingrey. Yes. Well, it seems like to me it would be
confusing for doctors and patients, let's say, to go online,
up-to-date WebMD, you pick it, and find different warnings and
contraindications for the exact same drug. I don't see how that
benefits public health when that happens.
Dr. Woodcock. Well, right now, of course there are drug
safety controversies, as you know. And there is much on the
blogosphere, on WebMD and everything else about different
reported papers with this cardiovascular risk, this risk.
Generally, FDA will put out a safety alert and say we are
evaluating this issue. Here is what we know so far. Here is
what we don't know. We will let you know when we have
definitive information. When we do, then we would require all
the manufacturers have the same label when we had----
Mr. Gingrey. Well, that is good news in my concluding 10
seconds because I was going to ask isn't it the FDA's job to
referee these disputes and make class-wide labeling changes?
Dr. Woodcock. Yes, it is, and we do that. Yes.
Mr. Gingrey. Mr. Chairman, I yield back.
Mr. Pitts. The chair thanks the gentleman. That concludes
the questions of the Health Subcommittee members who are here.
I am sure they will have written questions that they will
submit.
But at this time I would like to seek unanimous consent to
permit the gentleman, Mr. Braley from Iowa, to ask questions.
And without objection, so ordered.
The chair recognizes Mr. Braley 5 minutes for questions.
Mr. Braley. Thank you, Mr. Chairman. I really appreciate
the Committee's indulgence in allowing me to be part of the
hearing.
I want to follow up with a question, Dr. Woodcock, that Mr.
Shimkus raised about input from physicians or physician groups.
Dr. Woodcock. Yes.
Mr. Braley. We heard from Mr. Waxman about the friend-of-
the-court brief he filed in the Mensing case. Were you aware
that the American Medical Association, the largest physician
organization in the country, also filed a friend-of-the-court
brief in that case?
Dr. Woodcock. No.
Mr. Braley. OK. Assume for the moment that they did and
that one of the concerns they raised with the Supreme Court was
the ethical dilemma that physicians face when they are
confronted with inconsistent rules to protect their patients
who receive brand name drugs----
Dr. Woodcock. Yes.
Mr. Braley [continuing]. As opposed to rules that protect
their patients who purchase generic drugs.
Dr. Woodcock. Yes.
Mr. Braley. Is that the type of concern from healthcare
providers that would be relevant to the agency in deciding
whether or not to go forward with this rule?
Dr. Woodcock. Well, we just several weeks ago closed the
comment period and we got over 100 comments, some of them
fairly voluminous, so I hope we have received input from a
large number of sectors on this, including obviously the
clinical community.
Mr. Braley. Mr. Lance raised concerns about similarly
situated consumers being treated the same, but wouldn't that be
an example raised by a physician group, the largest in the
country, that would show how these different consumers of
medications can be treated differently and that could raise
concerns?
Dr. Woodcock. Well, I will say that certainly one of our
issues is that the entities that are supplying medicine for a
large number of patients in this country should stand behind
their medicines.
Mr. Braley. One of the things that came up was Sentinel
systems in your testimony, and this is a common word that is
used in trying to promote patient safety throughout the
healthcare delivery system, correct?
Dr. Woodcock. Yes.
Mr. Braley. In fact, the Joint Commission on Accreditation
of Healthcare Organizations uses a Sentinel event system that
requires any adverse event to be reported and then followed up
so you get to the root cause of what caused the problem and
develop an action plan to correct it. Are you familiar with
that concept generally?
Dr. Woodcock. Yes, I am very familiar with it.
Mr. Braley. So, don't generic manufacturers of drugs have
the same safety incentives as a matter of public health to warn
consumers as brand name manufacturers?
Dr. Woodcock. Well, I would certainly hope so. They have
the same regulatory requirements to be monitoring for the
impact of their drug and to find out if any new safety event
happened and to report it to the FDA.
Mr. Braley. And one of the concerns about this proposed
rule that I would think conservatives would be very happy about
is that it promotes personal responsibility and not shifting
the burden to take care of patients to taxpayers through
publicly funded healthcare systems. Isn't that true?
Dr. Woodcock. Not being a lawyer, it is difficult for me to
comment on that.
Mr. Braley. If we don't have a remedy for people harmed by
generic drugs and they have to go on Medicare and Medicaid, we
end up paying for it as taxpayers, don't we?
Dr. Woodcock. That would apparently be the case sometimes.
Mr. Waxman. Would the gentleman yield to me?
Mr. Braley. I only have a few more minutes.
Mr. Waxman. I know. I wanted to take it.
Mr. Braley. One of the things that we know is there have
been concerns raised about the cost of the proposed rule and we
have heard testimony that 80 percent of the medications being
dispensed are generics. The federal agency that is focused on
promoting public health as part of the National Academy of
Sciences is the Institute of Medicine----
Dr. Woodcock. Yes.
Mr. Braley [continuing]. And they have spent a lot of time
studying this whole problem with preventable medical errors and
especially medication errors. And this is a book they released
in 2007 called Preventing Medication Errors.
Dr. Woodcock. Right.
Mr. Braley. And in here they write that in 2000, a study
estimated that the cost of drug-related illnesses and deaths in
the ambulatory setting in the United States was $177.4 billion.
Dr. Woodcock. Yes.
Mr. Braley. That is a lot of money.
Dr. Woodcock. Absolutely.
Mr. Braley. So if 80 percent of that marketplace is generic
drugs and we would be talking about $140 billion cost
associated with not reducing this problem and promoting patient
safety. Isn't that true?
Dr. Woodcock. Well, I am very familiar with that book. I
think that put in a lot of different safety problems together
when they made those estimates. However, I would say that it is
imperative that everyone monitor safety drugs in the outpatient
and the ambulatory setting and that we improve our outcomes
with patients.
Mr. Braley. Well, with my 5 seconds left I just want to
mention Sophie Howe of Ames, Iowa, a young college student who
was harmed by a generic drug and ended up having a lot of added
cost associated with that, including payment of her student
loans that were accelerated when she had to drop out of school
because of her medical complications. And I think it is the
human faces behind this problem that we should be thinking
about.
Thank you.
Dr. Woodcock. Thank you.
Mr. Braley. I yield back.
Mr. Pitts. The chair thanks the gentleman. That concludes
the questions.
At this time, we will have written questions that we will
provide to you if you can please respond to those.
Thank you very much----
Dr. Woodcock. Thank you.
Mr. Pitts [continuing]. Dr. Woodcock, for your testimony
and for your patience today.
Before I call the second panel, I ask unanimous consent to
recognize the ranking member of the full committee, Mr. Waxman,
for 5 minutes for a statement.
Mr. Waxman. Thank you very much, Mr. Chairman.
I know this is extraordinary to allow this but I am not
going to be able to be here for the testimony of the next
panel.
But I did want to comment on the fact that there is a
disconnect at this hearing because people are talking about
whether the label is going to be the same, how long it will
take to be the same and whether the doctors are for this or not
for it. I just want to point out what is really going on at
this hearing.
The Supreme Court decision said that a generic drug
manufacturer cannot be held liable under state law to warn
people about the dangers of a drug that they manufacture that
they know about because they can't put it in the label because
under the law they cannot change their label unless the FDA
changes the label for the brand and the generic company.
So in my brief to the Court I said, look, if they can't
change their label, then they ought to be held liable under
state law for the failure to let FDA know that there is a
problem for which they ought to give some notice to the public.
It seems reasonable to me but the Court on a 5-to-4 basis said
no. The only thing that would make them liable is if they
failed to warn by a label change. And they can't make that
label change, and therefore, the generic drug industry could
open their champagne and drink to the success that they are
never going to be held liable for. And that is great if you are
never going to be held liable for them perhaps but it is not
great for the consumers.
The FDA has looked at this issue and said, well, wait a
minute. We have a requirement that brand name companies warn
the consumer and they can even change their label, and then
while we are considering whether or not we are going to impose
that label requirement on everybody, they could go forward with
it. But the generic drug companies can't do that.
Now, FDA is not looking at it from a legal liability. They
are just looking at it from patient safety. It doesn't make
sense that if a generic company discovers there is a problem,
not to have them warn people, just as it is required by the
brand name company. So they are changing the rules to be sure
the consumer is protected, but in the process, it could and
most likely would reverse the Supreme Court decision and make
the generic companies liable for failure to warn people if they
have the ability to warn them in a new label, just as the brand
name companies have.
So while we are talking about all these other issues, we
are missing what is really at stake here. We are going to hear
that, I think, in this next panel because Mr. Neas and others
are going to argue this is going to cost billions of dollars in
liability that they hadn't had to worry about in the past. But
I would submit that that doesn't make sense. Before the Supreme
Court case, they were liable and they had to anticipate that,
but they didn't have billions of dollars as a result of that
vulnerability of liability. They were able to manage that
reasonably well. And to expect, notwithstanding a report that
we are going to hear about, which I very much doubt its
validity, we are going to hear that, no, this is a big matter.
This is going to be a huge liability for them.
Well, whether it will or will not, they should be held to
the same standards in order to protect the public, and I hope
they are liable if they do something wrong by not warning
people in a label change. Because if they have information that
their drug, as they learn now, could harm people, they ought to
make that label change. Certainly, the brand name companies
have to do it.
So I wanted this chance to make this statement now because
I am not going to be able to be here to do it through
questions.
I just must say, Mr. Neas, you have got a report. I just
don't see it possibly being valid and it will be held up to
some further questioning by this panel. But I can't see how it
is valid. It seems to me highly inflated. It is like all the
people that come in here and we want to regulate them, they say
this will drive us out of business. And then when the
regulations go into effect, they do it for a fraction of the
cost. So I just think that people ought to put in perspective
what this hearing is really all about.
And as I have now straightened everybody out about what is
significant, I am going to leave you. Thank you, Mr. Chairman.
Mr. Pitts. The chair thanks the gentleman.
Now, we will have our second panel. Please come to the
witness table and I will introduce them in the order that they
will speak.
On our second panel today we have Mr. Michael Shumsky,
partner, Kirkland & Ellis; Mr. Ralph Neas, President and CEO of
the Generic Pharmaceutical Association; and Ms. Allison Zieve,
General Counsel, Public Citizen.
Thank you all for coming. Your written testimony will be
made part of the record. You will each have 5 minutes to
summarize your testimony.
And at this point the chair recognizes Mr. Shumsky, 5
minutes for his opening statement.
STATEMENTS OF MICHAEL D. SHUMSKY, PARTNER, KIRKLAND & ELLIS,
LLP; RALPH G. NEAS, PRESIDENT AND CEO, GENERIC PHARMACEUTICAL
ASSOCIATION; AND ALLISON M. ZIEVE, GENERAL COUNSEL, PUBLIC
CITIZEN
STATEMENT OF MICHAEL D. SHUMSKY
Mr. Shumsky. Chairman Pitts, Ranking Member Pallone, and
members of the subcommittee, thank you so much for inviting me
to testify today. Though I filed administrative comments on
these issues for a number of clients as part of my law
practice, I would like to make clear at the outset that I am
testifying today in my personal capacity and that the views I
express are solely my own.
Over the past 30 years, the Hatch-Waxman Act has generated
trillions of dollars in cost savings. And that phenomenal
success stems from a simple but brilliant insight. Because two
drugs with the same chemical and biological properties will
have the same safety profile, FDA can safely approve generic
versions of a previously approved drug without requiring new
independent clinical trials
And it is precisely because two drug products with the same
chemical and same biological properties will have the same
safety profile that the statute naturally requires that generic
drug labeling be ``the same as the labeling approved for'' that
product's brand name equivalent. In a single word, sameness is
both the statute's animating principle and the driving force of
its success.
FDA now wants to permit generic drug warnings that are
``inconsistent with the labeling for the RLD.'' That is the
brand name equivalent. The agency has no power to do so. In our
system of separated powers, the executive branch is bound by
the laws this Congress passes. Indeed, as the Supreme Court
explained the very same year Congress patched Hatch-Waxman,
``if the intent of Congress is clear, that is the end of the
matter for the agency must give effect to the unambiguously
expressed intent of Congress.'' By this standard, FDA's
proposal is indefensible. It pays no heed to Hatch-Waxman's
plain language which explicitly requires generic labeling to be
``the same as the labeling approved for'' the brand name
equivalent. And indeed, the statute further bars FDA from even
approving a generic drug for sale in interstate commerce if its
labeling is not ``the same as'' the approved labeling for the
brand name drug.
The proposal also ignores FDA's lengthy track record on
this issue. Indeed, FDA has repeatedly recognized the generic
labeling must be the same as the FDA-approved branded labeling
at all times. It did so during the first Bush Administration,
during the Clinton Administration, during the second Bush
Administration and in its Supreme Court brief in the Mensing
case earlier in this Administration.
And finally, FDA's proposal conflicts with the Supreme
Court's recognition in both Mensing and in Bartlett that it is
this Congress' statute, not merely FDA's regulations, that bars
generics from using different warnings on their products. As
the Court put the point very clearly in Bartlett, ``Congress'
decision to regulate the manufacture and sale of generic drugs
in a way that reduces their cost to patients but leaves generic
drug manufacturers incapable of modifying their warnings.'' In
other words, Hatch-Waxman represents, as the Court said,
''Congress' decision,'' not the FDA's.
I firmly believe that Hatch-Waxman's sameness requirement
is supported by sound public policy and that FDA's rulemaking
proposal threatens to harm the public health, but those issues
are beyond the scope of my testimony today.
I also understand that the Court's recent decisions in this
area are controversial, but as the Court recognized in Mensing
and Bartlett, FDA has no power to adopt this proposal until
this Congress changes Hatch-Waxman's core principle, the
sameness requirement that has made that law one of the most
successful pieces of legislation ever passed.
I have one minute left and I do want to highlight one thing
and it was I think a very telling and very important exchange
between Dr. Christensen on the one hand and Dr. Woodcock on the
other. Dr. Christensen asked Dr. Woodcock about the origins of
FDA's CBE proposal, and as she made clear, that proposal
originated as an exercise in the FDA's view of enforcement
discretion, meaning that the agency would not enforce the law
as Congress wrote it. She then said, however, over time, FDA
has changed its mind and now they interpret that to flow from
the statute itself as opposed to the agency's disregard for the
statute.
Let me translate that answer so that there is no mistaking
what it was. FDA has ignored the law so long that the law has
changed. That is a fundamental reordering of our Democratic
process and a direct threat to the separation of powers. And I
want to thank Chairman Pitts for holding this hearing so that
we can explore those very important issues about the nature of
our constitutional republic.
[The prepared statement of Mr. Shumsky follows:]
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Mr. Pitts. The chair thanks the gentleman and recognizes
the gentleman, Mr. Neas, 5 minutes for an opening statement.
STATEMENT OF RALPH G. NEAS
Mr. Neas. Good afternoon, Chairman Pitts, Ranking Member
Pallone, and members of the subcommittee. Thank you for
inviting me to testify on the FDA's proposed changes to generic
drug labeling. I am Ralph G. Neas, President and CEO of the
Generic Pharmaceutical Association.
This year we commemorate the 30th anniversary of the Hatch-
Waxman Act, which by any measure has been one of our most
effective laws ever passed. This remarkable law initially
projected to save maybe a few million dollars a year has saved
the U.S. healthcare system more than $1.2 trillion over the
past decade, $217 billion in 2012 alone.
The quality and affordability of generic medicines is vital
to public health and the sustainability of the healthcare
system. The very heart and soul of the Hatch-Waxman Act is the
sameness principle under which generic manufacturers must prove
to the FDA that their version of a drug contains the same
active ingredient as the brand product, is identical in
strength, dosage form, and route of administration, and
importantly for today's discussion, has the same labeling.
These requirements give consumers, doctors, and pharmacists
confidence in the safety and effectiveness of generic
medicines.
The top priority for generic manufacturers is assuring
patient safety for the hundreds of millions of people who rely
on our products to live healthier and longer lives. The
company's proactively participate with FDA to ensure the
timeliness, accuracy, and completeness of drug safety labeling
in accordance with all current regulations. These manufacturers
report all serious and unexpected adverse events to the FDA
within 15 days. All others report it quarterly or annually. The
generic industry takes these responsibilities seriously.
Unfortunately, the FDA's proposed rule would substantially
undermine the enormously successful Hatch-Waxman Act and put
both patient safety and healthcare savings at risk by directing
generic manufacturers to make unilateral labeling changes
without prior FDA approval. The rule creates a system whereby
multiple different labels, including different warnings, can
simultaneously exist in the marketplace for the same drug with
the same active ingredient.
Generic manufacturers only have access to the scientific
and medical evidence for their individual products representing
a fraction of the total market. They do not have access to the
clinical trial data and other proprietary information of the
brand manufacturer or current information and data from other
generic manufacturers. Only the FDA has access to all the data
and information. A generic manufacturer that unilaterally
changes its label therefore does so with incomplete
information.
It is difficult to overstate the negative implications of
the proposed rule on patient safety and on consumer access to
affordable medicines. Allowing for multiple different drug
labels in the market for the same product would upend 30 years
of law and regulation and create substantial confusion for
everyone in the healthcare system. Uniform safety information
provides certainty for patients and providers that they can
rely on consistent information and inform their decisions in
medical conversations.
Identical labels also underscore the critical point that
once generic medicines are approved by the FDA, they are proven
scientifically equal to the brand medicine in terms of safety,
efficacy, and quality. The risk of over-warning and the flood
of unnecessary labeling changes is substantial. Multiple
versions of critical safety information would inaccurately
imply therapeutic differences between the generic drug and
brand drug that do not exist. The exaggeration of risk and
inclusion of unsubstantiated warnings will cause provider
confusion and discourage the use of beneficial treatments.
In addition to seriously jeopardizing patient safety, the
proposed rule would also burden consumers, businesses, and
state and federal governments with billions of dollars in
increased prescription drug costs. A recent economic analysis
found that the proposed rule would conservatively add $4
billion annually to the Nation's already high healthcare cost,
including $1.5 billion in Medicare and other government
programs.
It should be no surprise that 19 organizations representing
those populations that most rely on access to affordable
generic drugs and representatives from virtually every sector
of the pharmaceutical supply chain, most importantly
pharmacists and pharmacy organizations representing more than
100,000 pharmacists and 45,000 pharmacies, have submitted
letters to the FDA raising their significant concerns that the
proposed rule could jeopardize patient access and patient
safety.
Unfortunately, neither the FDA nor the Office of Management
and Budget conducted a robust cost-benefit analysis as OMB is
required to do to examine the economic implications of this
rule in increased healthcare costs.
I am here today with a simple message. We can do better.
GPhA fully supports a streamlined, efficient, and transparent
process for timely submission in updating their safety
information for generic drugs for healthcare providers and the
public. A key element of any new system must include timely FDA
review of all available clinical data and safety signals,
including the nonpublic data of the NDA holder.
Underlying this process should be one bedrock principle:
Generic drug labels must be FDA-approved; it must be based on
scientific evidence. Such a system would advance our shared
goals of protecting the public health and improving patient
safety. Congress should ensure that the FDA has sufficient
resources to do so. We would welcome the opportunity to work
with others in the healthcare system in a multi-stakeholder
collaboration on this matter. The FDA should hear from patient
advocates, pharmacists, physicians, payers, not just trial
lawyers, and others in the supply chain who could offer
expertise, experience, and perspective.
The sustainability of our healthcare system depends on the
continued access to affordable generic medicines. We will work
hard to make sure that any changes to labeling rules and
regulations protect patient safety, align with federal law, and
do not hinder patient access to more affordable generic
medicines.
Thank you, Mr. Chairman.
[The prepared statement of Mr. Neas follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Pitts. The chair thanks the gentleman and now
recognizes Ms. Zieve 5 minutes for an opening statement.
STATEMENT OF ALLISON M. ZIEVE
Ms. Zieve. Thank you, Mr. Chairman.
I am general counsel of Public Citizen and director of
Public Citizen Litigation Group. Our office submitted the
citizen petition that the FDA granted in part by issuing the
proposed rule that we are discussing today.
Since 1984, despite considerable changes in the market, FDA
regulation of generic labeling has remained substantially
unchanged. Since 1985, at the request of Pharma and other
specific brand name manufacturers, the FDA has allowed the
brands to make safety-related labeling changes without prior
approval. The concerns that motivated the FDA to adopt these
changes being affected or CBE option 30 years ago--the need to
promptly inform patients and physicians and the interest and
efficiency and resource management--apply equally today.
FDA continues to lack the resources to be the primary
instigator of post-approval labeling changes and cannot timely
pre-approve every safety update. Therefore, today, with
generics comprising such a large percentage of all
prescriptions filled, to fulfill the goal of timely labeling
updates to physicians and patients, the CBE process must be
available to generic manufacturers as well.
The majority of labeling changes are initiated by
manufacturers, not by the FDA, and based on publicly available
adverse event reports and medical literature. The brand name
manufacturer drops to a small percentage of the market very
quickly after generics enter the market and often stop selling
the drug altogether. More than 400 unique drugs fall into this
category. In these instances, if generic manufacturers are not
actively monitoring and proposing safety updates, no
manufacturer is doing so at all. But at the same time, it is
undisputed that critical safety information may come to light
after entry of the generic onto the market and after exit of
the brand-name product.
The concern that the proposal will result in confusing or
inconsistent labeling is unwarranted, I think, based on
unfounded worst-case scenarios and belied by current practice.
For the past 30 years brand labeling has been different from
generic for months, or as Dr. Woodcock testified, up to a year
even in some cases after the brand updates the labeling. We
have seen no evidence of confusion.
And despite this sameness concern of Hatch-Waxman,
variations of labeling are built into current regulations and
have been for 30 years such as the listing of different
formulations or a different indication. Sameness has never been
a literal requirement of the law.
Yet again, physicians and pharmacists have not complained
of confusion. In fact, the National Physicians Alliance
submitted a comment to the FDA 2 weeks ago saying that
confusion is not their concern. Their concern is updated safety
information.
Finally, the manufacturers have argued, and I think this is
the real objection, that the proposed rule, if finalized, will
expose them to liability for failure to warn. They argue that
the proposed rule will increase the cost of generic drugs and
insurers may refuse to insure them and that some manufacturers
may even decline to enter the market. But both recent history
and current reality prove these theories wrong. Until 2011,
generic drug manufacturers faced the same liability risk that
they would under the revised rule because until the Court's
decision in Pliva v. Mensing, generic companies could be and
sometimes were sued for failure to warn and many cases were
resolved favorably to the patient. Even today, some lawsuits,
although far fewer, are brought in cases where the generic has
failed to make a required update. So the proposal would not
create a new cost but one borne and managed very well by the
industry until just 30 years ago and still borne fully today by
brand name manufacturers.
It is important to keep in mind--I think this has gotten
lost today--that lawsuits for failure to warn, when
meritorious, occur because a patient suffered injury due to the
lack of an adequate warning. Thus, the many lawsuits about
metoclopramide, for example, people took a drug for reflux and
developed the neurological disease tardive dyskinesia, which is
often permanent. Adverse event reports and studies documented
this problem for years but the brand name company did not
revise the labeling and the generics said nothing.
Of course, the manufacturer is not responsible every time a
patient is injured but sometimes the manufacturers, including
generic manufacturers, turn a blind eye and the current system
allows the generic manufacturers to do this. The result is more
injury and more cost because immunizing a company from
liability does not make the patient's costs go away. They are
carried by the patients, the health insurance, and taxpayers.
For this reason, by giving generic manufacturers the tools and
incentives to update safety labeling, the proposed rule will be
to a cost savings, savings in medical care for the patients who
will not be injured because they and their physicians are armed
with updated information about safety risks.
Thank you.
[The prepared statement of Ms. Zieve follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
[The supplemental information provided with Ms. Zieve's
statement is available at http://docs.house.gov/meetings/if/
if14/20140401/101823/hhrg-113-if14-wstate-zievea-20140401.pdf.]
Mr. Pitts. The chair thanks the gentlelady. I will begin
questioning. I recognize myself for 5 minutes for that purpose.
Mr. Shumsky, in responding to the bicameral letter sent to
the agency in January, FDA decided not to answer the question
whether the other sameness requirements included in Sections
505(j) of the Food, Drug, and Cosmetic Act extended beyond the
date of approval. Now that FDA has taken the position that the
statute does not in fact require sameness in labeling after the
date of approval, could it now be argued that the sameness
requirements for strength, dosage, route of administration only
apply at the time of approval as well? Is this not an absurd
result?
Mr. Shumsky. Mr. Chairman, thank you for the question. And
I think it really hits the nail on the head. It does
demonstrate the real absurdity of FDA's proposal because once
you take the position that sameness doesn't mean the same for
labeling, there is no principle basis for saying that sameness
does mean the same for strength, dosage, route of
administration, or any of the other requirements in the
statute.
Mr. Pitts. Can you please explain why FDA cannot make this
change without congressional action?
Mr. Shumsky. Sure. There are several reasons, all of which
were recognized by the Supreme Court originally in its Mensing
decision in 2011 and then its Bartlett decision just this past
term, in 2013.
The central statutory provision at issue here is Section
505(j) of the original statute, which specifically says the
generic product labeling must be the same as the labeling
approved for the brand name drug. There are a couple of other
provisions in the statute that are equally relevant. One
requires the secretary, which is the secretary of HHS whose
vested authority and the Commissioner of food and drugs when it
comes to drug approval determinations, it requires the
secretary to reject an abbreviated new application, that is a
generic drug application, where its labeling is not the same as
the branded drug.
And finally, there is a more recent provision of the
statute which specifically says that there are certain limited
exceptions to the sameness requirement. And we have heard about
a couple of them where an inactive ingredient in a product like
its coating is different than the brand manufacturer, there are
some specific exceptions. None of those exceptions apply to
warning or safety-related information and there is a further
provision of the statute which says that for certain
permissible exceptions, differences between generic and branded
labeling will not be considered misbranded if certain criteria
are met, but that language in the statute specifically
excludes--in other words, it says ``but not changes to the
warning section of the labeling,'' which I think represents
Congress' explicit recognition that a generic drug which bore
different warnings than its branded drug would be misbranded.
Mr. Pitts. Now, some have stated that the proposed rule
would simply return the legal landscape for generic drug
manufacturers with respect to failure-to-warn cases to where it
existed prior to 2011. Therefore, generic manufacturers would
assume the same type of liability they had before the Supreme
Court's decision. Is this an accurate assessment?
Mr. Shumsky. I don't believe that it is, Mr. Chairman.
Prior to 2011, no federal court of appeals had held the generic
drug manufacturers could be held liable for failure to warn. To
the contrary, one court had addressed that question. In 2008,
the Third Circuit Court of Appeals, which is based in
Philadelphia, ruled that state failure-to-warn lawsuits
targeting generic drug products were preempted. And prior to
the Supreme Court's 2009 decision in Wyeth, that was the
definitive word in the federal judiciary, in the federal court
system on generic liability. Two decisions came after Wyeth,
which did expose generic drug manufacturers to liability, one
of them was called Mensing out of the Eighth Circuit, the other
was called Demahy out of the Fifth Circuit. And as we all know,
the Supreme Court promptly reversed both those decisions.
Mr. Pitts. I have one more question I want to ask.
Currently, there is a period where the brand and generic drug
labeling differs. Usually, this occurs when a brand makes a
labeling change on their end and the generic drug manufacturer
has to make conforming changes. How is this scenario envisioned
under the proposed rule different in nature and scope from what
currently takes place?
Mr. Shumsky. Sure. It is a totally different situation.
Start with the language of the statute, which says the generic
drug has to have the same labeling that FDA has approved for
the brand. And so there will be a period of time where a brand
manufacturer executes one of these CBE-0 changes. FDA then has
to consider it and approve it before a generic can implement
it. This proposed rule has nothing to do with that scenario.
This rule says a generic on its own acting unilaterally can go
out, decide it doesn't think that the branded warning is good
enough anymore and put a warning onto its product that the
brand hasn't considered and that the FDA hasn't reviewed. It is
an apples-and-oranges situation.
Mr. Pitts. The chair thanks the gentleman. My time is
expired. The chair now recognizes the ranking member, Mr.
Pallone, 5 minutes for questions.
Mr. Pallone. Thank you, Mr. Chairman.
I wanted to ask Ms. Zieve. Today, we have heard a lot about
liability and I think it will be important to begin our
questions of this panel about the role it plays in this
context. So for the benefit of our members, could you describe
for us the role that tort liability plays regarding product
safety generally, and more specifically, in promoting the
safety of drugs and other FDA-regulated products? And could you
describe some of the kinds of harm that have been the subject
of failure-to-warn lawsuits?
Ms. Zieve. Thank you, Mr. Pallone.
I will start by quoting to you from what the Supreme Court
has said about state failure-to-warn suits in the drug context.
The Court wrote ``state tort suits uncover unknown drug hazards
and provide incentives for drug manufacturers to disclose
safety risks promptly. They also serve a distinct compensatory
function that may motivate injured persons to come forward with
information. Failure-to-warn actions in particular enforce the
FDA's premise that manufacturers, not the FDA, their primary
responsibility for their drug labeling at all times.''
I think one sort of prominent example of some of the public
health benefits beyond for the individual plaintiff comes
through the Vioxx cases where a tremendous amount of
information came to light only because of the personal injury
suits, information that not even FDA had, and it really helped
to move that process forward and eventually to get a very
dangerous drug off the market and find out what had happened in
that case.
There are unfortunately a number of examples of drugs,
branded and generic, that have caused serious safety problems.
Unfortunately, only, according to one study, about half of
serious problems are discovered in the first 7 years after new
drug is on the market. So even after the generic comes on the
market, we are still finding new safety risks.
I mentioned metoclopramide, which was marketed under the
brand name Reglan, in my opening remarks. Another example is
Accutane. This one is sort of particularly heartbreaking
because the patients who were injured were teenagers. They took
the drug for acne. It is purely aesthetic, right, but it is
very important to the teenagers. They take this, and
unfortunately, it can cause bowel disease that requires in some
cases surgery and it can really change their lives permanently
and in devastating ways.
And there was information for years and adverse event
reports and medical literature that this drug could cause this
serious problem and the brand name did nothing. And again, the
FDA does not have primary responsibility for labeling updates.
It can't. It doesn't have the resources. That is the premise of
the Food, Drug, and Cosmetic Act and of the regulations. But
the brand name manufacturer said nothing and the generics said
nothing because they don't have to.
When the FDA finally ordered a labeling change for Accutane
to warn of this serious problem, the brand promptly removed it
from the market. So today, this is a drug that has had serious
risks added throughout its I think it is 20 or 30 years now on
the market and the only products of Accutane sold today are the
generic so nobody has responsibility for that labeling today.
Mr. Pallone. And let me get to my second question. In my
opening statement I mentioned that I am sympathetic to the
questions surrounding sameness, which is the guiding principle
in Hatch-Waxman. How do you respond to the claim that the FDA
proposed rule fundamentally violates this sameness principal
and will undermine the statutory and regulatory framework for
approving and overseeing generic drugs?
Ms. Zieve. Well, I am glad you didn't say sameness
requirement because, as I mentioned, sameness has never been a
requirement. The FDA regulations have a section that lists
exceptions to sameness and these have been uncontroversial. The
most relevant one is actually during the period after a brand
makes a CBE change. The difference between the status quo today
and after what I hope will be the FDA finalization of the rule
is that that period of difference, that temporary deviation,
may be instigated by the generics just like today it is
instigated by the brands. And the FDA has fashioned the rule to
make sure that this temporary exception actually works a little
more efficiently than it works today.
Mr. Pallone. All right. I don't know if I have enough time.
I think I don't have enough time for my next question now, Mr.
Chairman. Thanks.
Mr. Pitts. The chair thanks the gentleman and now
recognizes the gentleman from New Jersey, Mr. Lance, 5 minutes
for questions.
Mr. Lance. Thank you, Mr. Chairman.
Ms. Zieve, were you an amicus in either the Mensing or the
Bartlett cases or a litigant in some way?
Ms. Zieve. My office filed an amicus brief in Mensing----
Mr. Lance. In Mensing.
Ms. Zieve [continuing]. And filed an amicus brief in
Bartlett, I believe on behalf of Mr. Waxman.
Mr. Lance. Thank you. And are you in agreement with the
Mensing and the Bartlett decisions?
Ms. Zieve. No, I think that they are wrong as a matter of
legal jurisprudence as well as policy.
Mr. Lance. I see. And certainly we can debate policy but
you believe the Supreme Court was wrong in both the Mensing and
Bartlett decisions?
Ms. Zieve. Right, I do, but I also think it is important,
particularly in Mensing today that the Supreme Court look to
the FDA's regulations and defer to the FDA's view of those
regulations in deciding that failure-to-warn suits were
preempted. The Court didn't hold that Hatch-Waxman required
that result but said specifically it was going to defer to the
FDA's view about its own regulations.
Mr. Lance. Thank you.
Mr. Shumsky, your view on Mensing and Bartlett?
Mr. Shumsky. I represented the petitioners in both of those
lawsuits and I think the Supreme Court did a fabulous job.
Mr. Lance. Thank you. Thank you. And this is a situation
where the question was litigated to the Supreme Court and the
Court made its decision. As I stated to Dr. Hamburg and I think
very often in these matters where you stand on issues of public
policy is based upon where you sit, if we want to modify the
underlying statute, Mr. Shumsky, do you believe we should ask
Congress to do that through our statutory power?
Mr. Shumsky. I certainly believe that if Congress is of the
mind that the public policy here needs to be altered to enable
the kind of liability the Mensing and Bartlett decisions----
Mr. Lance. Yes.
Mr. Shumsky [continuing]. Rejected, that Congress needs to
act to change the statute to do that. I remain firmly of the
belief that FDA has no authority on its own to do that.
Mr. Lance. Yes.
Mr. Shumsky. And I would say I think there are very sound
policy reasons underlying the Mensing and Bartlett decisions
which would counsel against those changes.
Mr. Lance. And your testimony would indicate that in the
Administration of President Bush, senior President Bush,
President Clinton, the junior President Bush, and President
Obama, at least at the beginning of his tenure in office, your
view was the view that was prevailing in the administrative
agency. Have I got that right?
Mr. Shumsky. Yes, Congressman, that is correct.
Mr. Lance. Thank you. Why in your opinion has there been a
change at the agency regarding this matter?
Mr. Shumsky. I can't speculate on what has prompted them to
turn around after 30 years of taking the position that these
labeling changes are impermissible.
Mr. Lance. And, Mr. Neas, do you have an opinion on that?
Mr. Neas. It would be speculative. All we have, however,
right now is that the FDA after, as Mike said, 30 years of
enforcing the law in a certain manner under several different
Democratic and Republican administrations made a change, and
that change was precisely what the trial lawyers and Public
Citizen recommended in 2011 and 2013, and they are the only
ones I believe who met with the FDA and think that is a
problem.
Mr. Lance. I am sorry, Ms. Zieve. You are welcome to
comment.
Ms. Zieve. Sorry. We didn't meet with FDA for what it is
worth.
Mr. Neas. Just the trial lawyers.
Mr. Lance. The trial lawyers, thank you. They have a
perfect right to meet with the FDA.
Mr. Neas. Absolutely.
Mr. Lance. Let me be on the record as saying that.
If the rule is finalized, will it likely be a matter of
litigation?
Mr. Neas. If the rule is finalized?
Mr. Lance. In its current form.
Mr. Neas. My guess is there is a strong likelihood that it
could be the subject of litigation from a variety of different
perspectives and constituencies.
Mr. Lance. And, Ms. Zieve, what is your opinion on that? If
the rule is finalized as it has been written, do you believe
this is likely to be litigated?
Ms. Zieve. Well, I would like to answer that in two ways. I
think given what the industry has been saying, it is likely
that they are going to want to litigate because they have been
saying that they will. But I also think that the rule is
perfectly permissible under the Food, Drug, and Cosmetic Act,
including the Hatch-Waxman amendments to that act.
Mr. Lance. Yes, thank you. I realize your opinion but you
believe it will be litigated is my question. You think it will
be litigated?
Ms. Zieve. Well, I believe that the industry has said that
they are going to litigate it.
Mr. Lance. Yes.
And, Mr. Shumsky, do you believe there will be litigation?
Mr. Shumsky. It has certainly been discussed but no final
decision has been made to the best of my knowledge.
Mr. Lance. Thank you, Mr. Chairman.
Mr. Pitts. The chair thanks the gentleman and now
recognizes the gentleman from Maryland, Mr. Sarbanes, 5 minutes
for questions.
Mr. Sarbanes. Thank you, Mr. Chairman. I thank the
panelists.
I think this is the least absurd proposal to come forward
from the FDA I have ever seen. I just wanted to mention that.
I gather there are three basic objections to this rule or
critiques of it. One is the increased costs that it represents
and I am not convinced that the report that is forecasting
those increased costs is based on valid assumptions. But let's
assume that there will be increased cost. As an objection to
the rule that should be the basis for not going forward, that
is a dog that just doesn't hunt because the American public
would say it is worth some additional cost in the system to
make sure that we are protected. And frankly, the cost that
will be saved to whatever industry is involved, as well as in
terms of potential damage and harm to individuals and families
and patients out there, the cost that will be saved make it
worth that investment if you want to look at it in those terms.
So I don't think the economic argument is going to carry the
day here and I noticed that neither of you lead with that
argument, Mr. Shumsky or Mr. Neas, probably because of that
reason.
The second objection is the notion that it will create
confusion and I read the letter that the pharmacists, among
others, submitted to Dr. Hamburg that you cited, Mr. Neas, and
they don't outright advocate against this rule. They advise
caution and they say the FDA and others need to fully explore
the potential unintended consequences that the rule may have on
patient access and national healthcare costs, et cetera. And I
think that that is exactly what FDA is doing. They are trying
to consider what the potential consequences here would be. They
are also going to great lengths in the rule to actually reduce
the potential for confusion and even reduce it from where it
stands now, as I understand it. So I see that as progress.
That then leaves the argument about kind of the statutory
interpretation. I don't buy that either because if you
subscribe completely to the notion that this sameness principle
has to have total integrity, then you would also have to take
the position that the brand name manufacturers should not be
permitted to put these interim labels on their products as a
matter of safety because for some period of time you would be
violating a very strict and literal interpretation of the
sameness concept because you would have a situation where you
would have some drugs that are identical to other drugs that
have different labeling on them.
It seems to me it is a very reasonable position for the
agency to have taken up until now that sameness ought to be
interpreted in context of public safety, and that is why you
have had a situation where innovators and brand-name
manufacturers have been putting these interim labels on their
products even though that for some period of time makes them
different from the generic manufacturing labeling because there
is an understanding that we are doing the best we can here to
protect the public and we have to interpret sameness in the
context.
And I think bringing that same perspective and lens, as the
agency is now trying to do by making it sensible for the
generic manufacturers to also make this change in their
labeling for some small period of time, is a perfectly sensible
thing to do. And so I guess there are no questions in that.
That is just my observation of the matter.
But I continue to support fully the proposal that has been
made. I think it is very, very reasonable and I don't think it
represents overreaching of the enforcement or interpretive
discretion and authority that the FDA has.
And with that, I yield back.
Mr. Pitts. The chair thanks the gentleman and now
recognizes Mr. Braley 5 minutes for questions.
Mr. Braley. Thank you, Mr. Chairman.
Mr. Shumsky, in your opening remarks, you made clear that
your testimony here today was in your personal capacity. Do you
remember that?
Mr. Shumsky. Yes, sir.
Mr. Braley. Have you or one of your family members ever
been harmed by a generic drug?
Mr. Shumsky. I have experienced side effects associated
with generic drugs. I am not sure I would characterize that or
any of my family's experiences as being harmed.
Mr. Braley. All right. Have you in your professional
capacity ever represented a client who claimed to have been
harmed by a generic drug?
Mr. Shumsky. No, sir.
Mr. Braley. You have represented generic drug manufacturers
in front of the Supreme Court, is that correct?
Mr. Shumsky. That is correct.
Mr. Braley. And were you here in my earlier comments when I
talked about a young woman from Ames, Iowa, who had taken a
generic drug and had a really bad outcome?
Mr. Shumsky. I was, Mr. Congressman.
Mr. Braley. OK. This is her picture. Her name is Sophie
Howe, and she began having some of the same problems with a
complexion medication that we heard mentioned earlier here
today, ended up having multiple pulmonary emboli, was
hospitalized with that, and had significant complications. At
the time she was a college student at Iowa State University,
and because of the complications of her injury, she was forced
to drop out of school. She had student loans that were paid for
and insured by the Federal Government that became due, and that
caused her to drop out of a community college program in order
to work full-time to pay off her student loans.
So when you walk into the Supreme Court building across the
street, you will see a sign up above that says ``Equal Justice
under Law,'' but the actual result of the Mensing decision is
to tell those claimants like Sophie Howe you have equal justice
under the law if you pay more for brand name drugs because she
has no remedy under the Court's decision, does she?
Mr. Shumsky. Not against the manufacturer of the generic
drug product, no.
Mr. Braley. Now, Mr. Neas, I want you to know that I am
glad that generic drugs are helping American patients by giving
them access to affordable medications where and when they need
them. And I also believe it is just as important that the
medications on the market are safe and that patients and
providers are aware of any possible threat to their health. In
this Mensing case we have been talking about, were you aware
that there was a friend-of-the-court brief filed by 43 state
attorneys general talking about the cost-shifting result of not
providing this remedy?
Mr. Neas. I do know that the state attorneys general took a
certain decision, sure, as they do.
Mr. Braley. In their brief they noted, ``Costs should not
be shifted to taxpayer-funded healthcare programs. This implied
preemption would put added pressure on state and federal
budgets. Not only would it be a significant incentive for
ensuring the safe use of prescription drugs be eliminated, but
injuries to consumers would go uncompensated by the wrongdoer,
and much of the resulting increase in healthcare costs would be
borne by state-funded programs.''
And, Mr. Chairman, I would ask unanimous consent for
recognition that the brief was filed by the attorneys general
from the States have Minnesota, Louisiana, Alabama, Alaska,
Arizona, Arkansas, California, Colorado, Connecticut, Delaware,
Hawaii, Idaho, Illinois, Indiana, Iowa, Kentucky, Maine,
Maryland, Massachusetts, Mississippi, Missouri, Montana,
Nebraska, Nevada, New Hampshire, New Mexico, New York, North
Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode
Island, South Carolina, South Dakota, Tennessee, Utah, Vermont,
Washington, West Virginia, Wisconsin, Wyoming, and the District
of Columbia.
Mr. Pitts. Without objection, so ordered.
Mr. Braley. Ms. Zieve, when we are talking about this cost-
shifting, are you aware that the same companies that are
generic drug manufacturers were held accountable before the
Mensing decision either through settlements or through claims
in court for failure-to-warn claims?
Ms. Zieve. Yes, I am aware that there were hundreds of
suits and at least in a few years leading up to Mensing that
there were a large number of settlements that are confidential
at the manufacturer's request.
Mr. Braley. After the Mensing decision, are you aware of
any instance where an insurer for one of those generic drug
manufacturers rebated portions of premiums that had been paid
based on a potential assumption of liability for failure-to-
warn claims among generic manufacturers?
Ms. Zieve. I am not aware of that. I am also not aware of
any decrease in the cost of generics to consumers because of
the elimination of liability.
Mr. Braley. Thank you, Mr. Chairman. I yield back.
Mr. Pitts. The chair thanks the gentleman. That concludes
the questions of the Members.
The ranking member has a unanimous consent request. He will
be recognized for that purpose.
Mr. Pallone. Thank you, Mr. Chairman.
I ask unanimous consent that the Committee include in the
record the following: a comment letter to the FDA on the rule
by 41 Members of Congress, including myself and Mr. Waxman; New
York Times editorial in support of the FDA rule; comment
letters to FDA on the rule, well, three, one including the
patient and consumer groups and the Consumer Union; the state
attorneys general from 30 States, and from an attorney, Brandon
Bogle.
Mr. Pitts. Without objection, so ordered.
[The information appears at the conclusion of the hearing.]
Mr. Pitts. That concludes the questions from the Members
who are present. We have another hearing going on and I am sure
other Members will have questions. We will send those to you in
writing. We ask that you please respond promptly.
I remind Members that they have 10 business days to submit
questions for the record and I ask the witnesses to respond
promptly. Members should submit their questions by the close of
business on Tuesday, April 15.
Thank you very much for your testimony today. It has been a
very informative hearing.
And without objection, the subcommittee is adjourned.
[Whereupon, at 5:13 p.m., the subcommittee was adjourned.]
[Material submitted for inclusion in the record follows:]
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