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Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

Our Comment in Support of the FDA’s Proposed Rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985)

Posted in Generic Drugs, Preemption
Janice L. Weiner
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave.
Bldg. 51, Room 6304
Silver Spring, MD 20993-0002

 

Dear Ms. Weiner,

We are grateful for the opportunity to submit comments in support of the Food and Drug Administration’s (FDA) proposed rule entitled, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985).

Currently, a generic drug’s design and warning label must identically match that of the name-brand version of the drug. In turn, generic manufacturers are prohibited from making any material changes to the drug’s design or warning label. As a result, generic manufacturers cannot be sued for providing consumers with unsafe medications.

It is outrageous that a generic drug manufacturer can know that a warning label is inadequate, sell the drug anyway, and escape all liability. We believe that the proposed rule, which holds both generic and brand-name manufacturers responsible for informing the public about known risks of their medications, will promote health, safety, and equality.

 The Fourteenth Amendment Supports the Proposed Rule

The Equal Protection Clause of the Fourteenth Amendment to the United States Constitution prohibits states from discriminating between the “poor” and the “rich.” A state can no more discriminate on account of financial status than on account of religion, race, or color. See Griffin v. Illinois, 351 U.S. 12, 17, 76 S. Ct. 585, 590, 100 L. Ed. 891 (1956). See also  U.S.C.A.Const. Amend. 14; S.H.A.Ill.Const. art. 2, § 19.

“Courts have confronted, in diverse settings, the ‘age-old problem’ of [p]roviding equal justice for poor and rich, weak and powerful alike.” M.L.B. v. S.L.J., 519 U.S. 102, 110, 117 S. Ct. 555, 560, 136 L. Ed. 2d 473 (1996) quoting Griffin v. Illinois, 351 U.S. 12, 16, 76 S.Ct. 585, 589, 100 L.Ed. 891 (1956). We think the pharmaceutical industry is the newest “diverse setting” where this “age-old problem” must be resolved; and we are grateful that the proposed rule seeks to do just that.

The current law, which holds manufacturers of generic drugs to a lesser legal standard than their brand-name counterparts, essentially discriminates between the poor and the rich. After all, the only difference between brand-name drugs and their generic equivalents is price. Generic brands are often significantly less expensive than their brand-name counterparts.

In fact, generic drugs were originally made in an effort to ensure that effective and safe drugs were widely and inexpensively available to citizens who could not otherwise afford medications. Thus, people who are less financially well-off are the ones who were, and are, specifically intended to purchase generic drugs. In other words, poor people buy generic brands.

If someone takes a brand-name medication and develops a disease as a result of taking the brand-name medication, she can sue the company that manufactured the drug. Those who can afford the brand-name drug in the first place are the ones—and only ones—who are allowed to be compensated for injuries sustained from ingesting an unsafe drug.

On the other hand, if a financially less-fortunate individual goes to the pharmacy and inevitably opts for the cheaper generic version of the drug, and develops the same disease or adverse side effect, she cannot sue the generic manufacturer. Instead, she is left to incur medical expenses for the harm she suffers as a result of consuming the unsafe drug, even though she is just as innocent as the financially well-off consumer.

It is heartbreaking that the very people who cannot afford brand-name drugs in the first place are singled out and deprived of the right to be justly compensated. The result is that “rich” people are protected under the current federal law, while “poor” people are not. The proposed rule, by contrast, which protects consumers of brand-name drugs as well as consumers of generic equivalents, works to conform to the Equal Protection Clause of the Fourteenth Amendment.

 The Proposed Rule Will Save Courts Time and Resources

 We had mixed feelings with regard to a recent order issued by a Federal District Judge in Illinois in the case of Dolin v. Smithkline Beecham Corporation d/b/a Glaxosmithkline, which found that, under Illinois law, a brand-name manufacturer owes a duty to consumers of generic versions of its drugs. The ruling was as good as anyone could hope for under the current law.

The plaintiff in the case is a woman whose husband committed suicide after taking a medication called, paroxetine, which is manufactured by Mylan, Inc. Paroxetine is the generic version of the brand-name drug, Paxil, which is owned and manufactured by GlaxoSmithKline (“GSK”). The plaintiff brought a wrongful death action against both GSK and Mylan.

The Judge had no choice but to find that Mylan could not be held liable, because federal law preempts claims against manufacturers of generic versions of brand-name drugs. However, creatively, the Judge found that the brand-name manufacturer could be held liable even though it was not the company that actually manufactured the pill that resulted in the plaintiff’s husband’s fatality.

We are pleased because at least the Judge found that the plaintiff could be compensated by one of the negligent companies. However, we believe that the Judge had to go around his hand just to get to his thumb. The Judge issued an intricate 26 page opinion, exploring vague precedent to “get around” the law that states generic manufacturers cannot be sued. It seems a great deal of the court’s time and resources were wasted as a result.

We believe that the proposed rule, which holds both generic and brand-name manufacturers responsible for informing the public about known risks of their medications, will save the courts time and resources because judges will have a clear, set standard.

Conclusion

Thank you again for the opportunity to submit comments in support of the Food and Drug Administration’s (FDA) proposed rule entitled, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985). As explained above, in addition to saving the courts valuable time and resources, we believe the new rule will promote health, safety, and equality in our society.