[Congressional Record Volume 158, Number 56 (Wednesday, April 18, 2012)]
[Senate]
[Pages S2497-S2500]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
By Mr. LEAHY (for himself, Mr. Franken, Mr. Coons, Mr.
Whitehouse, Mr. Bingaman, Mr. Brown of Ohio, and Mr.
Blumenthal):
S. 2295. A bill to permit manufacturers of generic drugs to provide
additional warnings with respect to such drugs in the same manner that
the Food and Drug Administration allows brand names to do so; to the
Committee on Health, Education, Labor, and Pensions.
Mr. LEAHY. Mr. President, today, I am introducing legislation that
will protect American consumers by improving the labeling on
prescription drugs to promote consumer safety. This important bill will
ensure that all drug manufacturers can update the warning labels for
their products so that the information provided to doctors and
consumers is as accurate and up-to-date as possible. It is a
straightforward measure that has the support of patient groups and
consumer advocates. I am pleased that Senators Franken, Coons,
Whitehouse, Bingaman, Brown of Ohio, and Blumenthal
[[Page S2498]]
have joined me as original cosponsors of the bill.
The Patient Safety and Generic Labeling Improvement Act will promote
consumer safety by ensuring that generic drug companies can improve the
warning information for their products in the same way that brand
manufacturers can under existing law. This ability is especially
important given the large role that generics play in the market for
prescription drugs. The Department of Health and Human Services reports
that generic drugs now make up 75 percent of the market for
pharmaceuticals. Studies show that when a generic version of a drug is
available, 90 percent of prescriptions are filled with the generic
version of the drug. The large role that generics play in the market
gives them important insight into side effects experienced by their
customers. The Patient Safety and Generic Labeling Improvement Act will
allow generic manufacturers to act on this information, by authorizing
them to improve their labels to provide accurate and up-to-date
warnings to consumers.
A recent Supreme Court decision, Pliva v. Mensing, created the need
for this important legislation. In the Mensing case, a narrow 5 4
majority on the Court held that a Minnesota woman, Gladys Mensing,
could not recover for debilitating injuries she received from a
mislabeled drug that was intended to treat her diabetes symptoms.
Despite evidence that long-term use of the drug could cause a severe
neurological condition known as tardive dyskinesia, the manufacturer's
label did not expressly warn against long-term use until years after
Ms. Mensing began taking the drug. She developed the condition, losing
control of muscles in her face, arms and legs.
Ms. Mensing's injuries are life-changing and irreversible. The
Supreme Court held that she cannot be compensated for the drug
company's failures because of a technicality in the law. That
technicality arose because Ms. Mensing's pharmacy had filled her
prescription with the generic version of the drug. The Supreme Court
held that, unlike brand name companies, generic manufacturers cannot be
held liable for inadequate labeling, because they cannot change the
labels on their products independently. Generic manufacturers should
have the ability to participate fully in the labeling process, but they
are unable to do so. More important to injured consumers, there is no
remedy for them. The generic manufacturers can use this Supreme Court
decision and the quirk in the labeling laws to avoid any
accountability, even if they fail to inform the FDA that a label is
inadequate.
The Mensing decision creates a troubling inconsistency in the law
governing prescription drugs. If a consumer takes the brand-name
version of drug, she can sue the manufacturer for inadequate warnings.
If the pharmacy happens to give her the generic version, as happened to
Ms. Mensing, she is unable to seek compensation for her injuries. The
result is a two-track system that penalizes consumers of generic drugs
even though many consumers have no control over which drug they take,
because their health insurance plan or state laws require them to take
generics if they are available.
In an editorial published last month, The New York Times criticized
the inconsistency of this outcome, writing: ``Same drug. Same
devastating health consequences. Opposite results. This injustice will
affect more people as generics, which already dominate the market,
expand even more under the pressure to control health care costs.''
Even Justice Thomas, writing for the majority in Mensing, acknowledged
the inconsistent outcome, writing: ``[I]t is not the Court's task to
decide whether the statutory scheme established by Congress is unusual
or even bizarre.'' Writing in dissent, Justice Sotomayor accurately
warned of ``absurd consequences'' that will flow from the
``happenstance'' of whether a prescription was filled with a brand-name
or generic drug.
I agree that having different rules for patients who take generic and
brand-name drugs makes little sense, and raises significant policy
concerns. It is also troubling that generic manufacturers cannot update
their safety labels in the same way that brand manufacturers can. In
today's world, where generic drugs make up 75 percent of the
prescription drug market, all manufacturers should be able to improve
the warning information they provide to doctors and consumers. The
Patient Safety and Generic Labeling Improvement Act will achieve this
goal.
This legislation is not intended to overburden the makers of generic
drugs. Instead, it authorizes generic drug manufacturers to act upon
drug safety information that they already gather pursuant to existing
regulation. The FDA requires generic manufacturers to monitor,
investigate and report adverse side effects experienced by users of
their drug. Generics already must submit an annual report to the FDA
summarizing new information that ``might affect the safety,
effectiveness or labeling of a drug product'', including a
``description of actions they have taken or intend to take as a result
of this new information''. When brand-name manufacturers exit the
market--as is often the case after generics are introduced--generics
may be the only manufacturers who gather this information.
The Patient Safety and Generic Labeling Improvement Act authorizes
generics to act on the information they gather to improve the labeling
on their product in the same way that brand-owners may do under
existing law. It creates an exception to the general requirement that
the labeling of a generic drug must be the same as the labeling of its
brand-name or listed equivalent, and instead allows generic
manufacturers to initiate a labeling change where that process is
available to brand-name manufacturers. Under the law, a generic
manufacturer would be able to use the ``Changes Being Effected''
process that permits manufacturers to implement a labeling change while
the change is simultaneously reviewed by the FDA. When a labeling
change is made under this provision, the FDA would be authorized to
order conforming changes across equivalent drugs to ensure consistent
labeling among products.
This legislation has the support of public interest groups and
advocates, including the AARP, Public Citizen, the Alliance for
Justice, and numerous consumer groups.
I have long worked to ensure that safe, affordable generic drugs are
available to American consumers. Earlier this Congress, I introduced
legislation to facilitate the importation of low-cost generic drugs
from Canada, a measure that will increase competition and help drive
down the prices of prescription drugs. We all benefit from the
availability of safe, affordable medication to help reduce the
overwhelming costs of healthcare.
The legislation I am introducing today will promote accountability
and ensure that all drug makers can take appropriate steps to enhance
warnings given to doctors and consumers. I hope that other Senators
will join me and my cosponsors in supporting this important
legislation.
Mr. President, I ask unanimous consent that the text of the bill and
letters of support be printed in the Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:
S. 2295
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Patient Safety and Generic
Labeling Improvement Act''.
SEC. 2. WARNING LABELING WITH RESPECT TO GENERIC DRUGS.
Section 505(j) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355(j)) is amended by adding at the end the
following:
``(11)(A) Notwithstanding any other provision of this Act,
the holder of an approved application under this subsection
may change the labeling of a drug so approved in the same
manner authorized by regulation for the holder of an approved
new drug application under subsection (b).
``(B) In the event of a labeling change made under
subparagraph (A), the Secretary may order conforming changes
to the labeling of the equivalent listed drug and each drug
approved under this subsection that corresponds to such
listed drug.''.
____
AARP,
March 30, 2012.
Hon. Patrick J. Leahy,
U.S. Senate,
Washington, DC.
Dear Senator Leahy: AARP is pleased to endorse your
legislation, the Patient Safety
[[Page S2499]]
and Generic Labeling Improvement Act, to address the issue of
whether generic drug manufacturers have a duty to include new
warnings about potentially serious side effects on their
labels as they become known. Your bill would accomplish this
by giving generic drug makers the same ability to update
their labeling as currently exists for manufacturers of brand
name drugs.
AARP believes generic drugs are one of the safest and most
effective ways for consumers to lower their prescription drug
costs, and we encourage our members to use generic drugs
whenever possible. However, AARP is concerned that, unlike
brand name drug manufacturers, generic drug manufacturers
cannot be held liable for inadequate drug warning labels due
to their inability to directly update their labels under
current law.
As noted in an AARP Foundation amicus brief submitted in
Pliva v. Mensing, AARP believes that holding generic drug
makers to a lower standard will effectively punish consumers
for choosing generic drugs and send the message that generics
are less trustworthy than name brand drugs--directly counter
to the intent of the Hatch-Waxman Act. We are encouraged by
your bill and hope it will serve to not only ensure patients
have adequate legal protections, but also prompt improvements
to the FDA process for updating warning labels when new
information about potentially harmful side effects comes to
light.
We thank you for your leadership in this area, and we look
forward to working with you and your colleagues on both sides
of the aisle to advance the Patient Safety and Generic
Labeling Improvement Act. If you have any further questions,
please feel free to call me or have your staff contact KJ
Hertz of our Government Affairs staff at 202 434 3770.
Sincerely,
Joyce A. Rogers,
Senior Vice President, Government Affairs.
____
April 17, 2012.
Hon. Patrick Leahy,
U.S. Senate,
Washington, DC.
Dear Chairman Leahy: We write to express our strong support
for the Patient Safety and Generic Labeling Improvement Act,
which would promote consumer safety by ensuring that generic
drug companies can improve the warning information for their
products in the same way that brand manufacturers can under
existing law.
By authorizing generic manufacturers to improve their
labels using the same ``Changes Being Effected'' process that
is currently available to brand-name manufacturers, this
legislation will help protect millions of Americans. The
Department of Health and Human Services reports that generic
drugs now make up 75 percent of the market for
pharmaceuticals, and studies show that when a generic version
of a drug is available 90 percent of prescriptions are filled
with the generic.
This much-needed legislation responds to the Supreme
Court's 2011 decision in PLIVA v. Mensing, in which the Court
held 5 4 that a Minnesota woman, Gladys Mensing, could not
recover damages for debilitating injuries she received from a
drug with an inadequate warning label simply because her
prescription was filled with the generic version of the drug,
rather than with the brand-name drug. The Court previously
held in Wyeth v. Levine (2009) that federal law does not
preempt failure-to-warn claims against brand-name drug
manufacturers. The Mensing decision thus created an arbitrary
distinction whereby a court's ruling on whether or not a
consumer can obtain relief turns solely on the happenstance
of whether his or her prescription was filled with a brand-
name or generic drug.
This troubling and unfair inconsistency in the law is
exacerbated by the fact that many consumers have little
control over which version of a drug they are given. Many
brand-name manufacturers exit the market after generics are
introduced. Moreover, many state laws and health insurance
plans require consumers to be given generics if they are
available.
Given the inherent unfairness of the current law and the
ongoing harm to millions of Americans, the Senate should pass
this legislation without delay.
Sincerely,
Alliance for Justice, Consumer Action, Consumer
Federation of America, Consumers Union, Consumer
Watchdog, National Association of Consumer Advocates,
and US PIRG.
____
Public Citizen,
Washington, DC, April 18, 2012.
Re Letter in support of Patient Safety and Generic Labeling
Improvement Act
Hon. Patrick Leahy, Chairman,
U.S. Senate, Committee on the Judiciary,
Washington, DC.
Dear Chairman Leahy: Public Citizen, a nonprofit consumer
advocacy organization with 250,000 members and supporters
nationwide, writes to applaud your introduction of
legislation that would give generic drug manufacturers the
authority to revise labeling for their products when they
become aware of risks that are not adequately disclosed. This
bill would fill a gaping hole in drug regulation that poses a
threat to patients' health and safety.
Your legislation reflects the concerns voiced by Public
Citizen in a citizen petition that we submitted to the Food
and Drug Administration in August 2011. As we explained in
the petition, the generic drug market has grown exponentially
in the past 25 years, and generic drugs now constitute a
majority of the prescription drugs sold in the United States.
The growth of generic drug sales reflects the fact that
generics offer equally effective but more affordable
alternatives to their brand-name counterparts. The regulatory
system, however, has not adjusted to the marketplace.
Under current law, a generic drug manufacturer is not
authorized to revise product labeling when it becomes aware
of inadequacies in the labeling. Specifically, FDA
regulations provide that, unlike brand-name manufacturers,
generic drug manufacturers are not permitted to initiate
labeling revisions to strengthen warnings, contraindications,
or precautions. As a result, the millions of patients who use
generic drugs may not have access to up-to-date information
on safety and proper use. And generic drug manufacturers lack
incentive to monitor and ensure the safety of their products,
even when the generic versions represent a majority of the
market for a particular drug. Your legislation would correct
this problem.
Your bill would also correct an illogical inconsistency in
the accountability that generic and brand-name drug
manufacturers have to patients. In a 2011 decision, PLIVA v.
Mensing, the Supreme Court relied on FDA regulations to hold
that a consumer injured by a generic drug with inadequate
warnings cannot seek compensation under state law for failure
to warn. By contrast, in a 2008 decision, Wyeth v. Levine,
the Court had held that manufacturers of prescription drugs
could be held accountable to patients for harm their drugs
caused. The Justices in Mensing itself noted that this
inconsistency ``makes little sense,'' with four Justices
calling it ``absurd.''
As the Supreme Court has noted, ``the FDA has limited
resources to monitor the 11,000 drugs on the market, and
manufacturers have superior access to information about their
drugs, especially in the postmarketing phase as new risks
emerge.'' Under your bill, generic drug manufacturers, who
already have access to relevant safety information, would be
able to revise their labeling as new information comes to
light, thereby making their products safer for patients.
For these reasons, Public Citizen strongly supports your
intent to fill the regulatory gap in generic drug safety. We
look forward to working with you to pass this important
legislation.
Sincerely,
Allison M. Zieve,
Director,
Public Citizen Litigation Group.
Sidney M. Wolfe, MD,
Director,
Public Citizen Health Research Group.
____
[From the New York Times, Mar. 23, 2012]
A Bizarre Outcome on Generic Drugs
Dozens of suits against drug companies have been dismissed
in federal and state courts because of a decision by the
Supreme Court last year that makes it virtually impossible to
sue generic manufacturers for failing to provide adequate
warning of a prescription drug's dangers. This outrageous
denial of a patient's right to recover fair damages makes it
imperative that Congress or the Food and Drug Administration
fashion a remedy.
This situation is particularly bizarre because patients
using the brand-name drug can sue when those using the
generic form of the drug cannot, as explained by Katie Thomas
in The Times on Wednesday. In 2008, the Supreme Court ruled
that a Vermont woman who had her hand and forearm amputated
because of gangrene after being injected with a brand name
antinausea drug could sue the manufacturer for inadequate
warning of the risks; she won $6.8 million from Wyeth.
In 2011, the court ruled that similar failure-to-warn suits
could not be brought against makers of generic drugs. As a
result, an Indiana woman who was also forced to have her hand
amputated because of gangrene after being injected with a
generic version of the same antinausea drug had her case
dismissed.
Same drug. Same devastating health consequences. Opposite
results. This injustice will affect more people as generics,
which already dominate the market, expand even more under the
pressure to control health care costs.
The Supreme Court's disparate rulings hinge on the ability
of the drug makers to change a warning label if they detect
new evidence of dangers. In 2008, the court found that brand-
name manufacturers had the unilateral power to change
warnings through various mechanisms even before asking the
Food and Drug Administration for a formal change.
Then, in 2011, the court found that, under the F.D.A.'s
interpretation of a 1984 law, known as the Hatch-Waxman
amendments to the Food, Drug and Cosmetic Act, the generic
versions must carry warning labels identical to those of the
brand-name drug. The goal was to minimize confusion and
dispel any doubt that a generic was therapeutically
equivalent to the brand-name drug. Generic makers can't
change the warnings but can propose a change to the F.D.A.,
which can then bring about a revision of the brand-name label
to trigger a corresponding change in the generic label. The
court ruled that because the generic makers do not control
the
[[Page S2500]]
labeling, they cannot be sued under state law for inadequate
warnings.
Justice Clarence Thomas, writing for the majority in 2011,
acknowledged that the distinction ``makes little sense'' in
the eyes of consumers, and Justice Sonia Sotomayor, writing
the dissent, predicted ``absurd consequences'' depending on
the ``happenstance'' of whether a prescription was filled
with a brand-name or generic drug.
Congress should fix the disparity by amending the law to
make it clear--as Representative Henry Waxman, a co-author of
the statute contends--that the act did not intend to preempt
all failure-to-warn claims. Alternatively, the F.D.A. should
fix the liability problem by amending its regulations to
allow generic manufacturers to change the warning labels.
Generic drugs have rapidly expanded their reach, and, by
one estimate, from one-third to one-half of all generic drugs
no longer have a brand-name competitor. The regulatory system
needs to hold generic companies, many of them large
multinationals, accountable for labels on the products they
sell.
Mr. FRANKEN. Mr. President, Gladys Mensing lives in Owatonna, MN. She
loves being around people. That is a good thing when one has a family
as big as Gladys does. She is the loving mother of 8 children, with 15
grandchildren and 12 great-grandchildren.
Gladys, as I said, is from Owatonna. It is in southeastern Minnesota.
A few weeks ago, I received some old family videos that showed her
playing with her grandkids. Gladys used to work as a waitress and as an
apartment manager, but what she truly enjoys is a good game of bingo.
In 2001, Gladys's doctor gave her a prescription for a medication
known as MCP to treat a digestive tract condition. Gladys did what I
would have done--she took her prescription to the pharmacy, got it
filled, and started taking her medicine per her doctor's orders.
Meanwhile, however, evidence was mounting linking MCP to neurological
disorders. Within a few years, Gladys began experiencing problems. She
lost control of her face, tongue, and legs. It is very hard to
understand Gladys when she speaks now. Her son says people sometimes
give Gladys strange looks when she goes out in public. Gladys used to
be very strong and independent. Now her family has to help her bathe
and walk.
Gladys wanted to hold the drug manufacturer accountable for what
happened to her. She believed the warning label that came with her
prescription was inadequate; that it did not sufficiently disclose the
risks of taking MCP. So Gladys, a bingo-playing grandma from rural
Minnesota, decided to stand up for her rights.
Gladys took her fight all the way to the U.S. Supreme Court, but that
is where things took a bizarre turn. In Minnesota, as in many other
States, the law requires drug manufacturers to warn patients of the
known--the known--dangers associated with their products. Manufacturers
that do not follow the law are held accountable to the patients who are
harmed as a result--people such as Gladys.
But the Supreme Court--in a 5-to-4 decision--said those laws do not
apply to generic drugs such as the medicine Gladys was taking. Rather,
the Court said Federal regulations actually prohibit generic drug
manufacturers from updating their labels--prohibit generic drug
manufacturers from updating their labels--and it said the Federal
regulations prohibiting label changes trump Minnesota's patient
protection laws, which require full disclosure of potential risks. So
under that ruling, even if a generic drug company wanted to provide
better warnings of risks to consumers, it cannot.
Generic drugs are, for all intents and purposes, the same as brand-
name drugs. They have the same active ingredients. They are used for
the same purposes and, yes, in most cases, they should have the same
labels. That is why current FDA regulations require generic drug labels
to match brand-name drug labels. But it does not make sense to prohibit
generic drug makers from updating their labels to accurately reflect
new side effects or risks that have come to light. Yet that is the
current state of the law.
So the Court dismissed Gladys's case just because she was taking a
generic drug. Let me say that again. Because Gladys was taking the
generic version of her medicine, she was unable to vindicate her rights
under Minnesota law. If Gladys had suffered the same injuries from the
brand-name version of the same pill containing the same warning, she
would have had her day in court.
Since the Supreme Court dismissed Gladys's case last June, lower
courts have dismissed dozens of similar cases because, as a recent
article in the New York Times aptly said, ``What once seemed like a
trivial detail--whether to take a generic or brand-name drug--has
become the deciding factor in whether a patient can seek legal recourse
from a drug company.''
That does not make any sense. Justice Thomas, who wrote the Supreme
Court's decision in Gladys's case, admitted as much. He wrote this:
We recognize that from the perspective of Mensing . . .
[this decision] makes little sense.
I agree with him on this point. I would like to think he would agree
with me on this: Prescription drugs should be safe and their labels
should be adequate.
So Senators Leahy, Bingaman, Brown, Whitehouse, Coons, Blumenthal,
and I are introducing a bill that would guarantee just that. Our bill,
the Patient Safety and Generic Labeling Improvement Act, would allow
generic drug makers to update their warnings--allow them to update
their warnings--to accurately reflect the known risks associated with
their drugs. That is it. It would not require them to do so. It just
lets them do what other drug manufacturers already are allowed to do.
Our bill says that millions of Americans who are taking generic drugs
are entitled to the same protections as people who take brand-name
drugs, and it says people such as Gladys Mensing are entitled to their
day in court when manufacturers fail to disclose risks.
I thank Senator Leahy for his leadership on this issue and urge my
colleagues to join with us in supporting this commonsense fix.
______