[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.
                                 ______