Decision Misprision

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It seems that lately, when it comes to health care policy, we are living in the land of unintended consequences. A recent Supreme Court ruling is a set back to addressing quality concerns in generic drugs.

This article published with permission from The Burrill Report.

It seems that lately, when it comes to health care policy, we are living in the land of unintended consequences.

After the U.S. Supreme Court’s recent 5-4 decision in Mutual Pharmaceutical Co. v. Bartlett established that makers of generic drugs cannot be sued under state law for adverse reactions to their products, the one-eyed man is measuring the throne room.

Writing for the majority, Justice Samuel Alito argued that state law cannot trump federal laws regarding prescription medicines whose design has been approved by the U.S. Food and Drug Administration. The obvious first question is: why doesn’t federal preemption hold for innovator products?

And then there’s the more important question of patient safety. While there is no language in the Bartlett decision on either bioequivalence or therapeutic interchangeability, the unintended consequence of the court’s decision is that many payers and physicians — now that the burden of potential legal entanglements has been lifted — will now consider generics “the same” as their innovator forefathers and prescribe accordingly.

And since the Supremes made no special mention of Narrow Therapeutic Index, well, Katie un-bar the door for anti-seizure meds, anti-depressants and more. That’s not good.

The court’s decision also undermines the urgency of educating payers, physicians and patients on the subject of generic drug quality — and this goes further than just excipient changes.

How to educate the various relevant publics on bioequivalence is one of our nation’s most important and yet invisible problems. Not that we were trying very hard before, but as we approach the reality of both small molecule patent expirations and biosimilars, the issue becomes less and less academic and more and more practical. For example, how will the court’s decision impact the International Nonproprietary Naming debate?

The court’s decision has thrown yet another cloak of invisibility over the urgent need for quality maximization.

William Gladstone famously said that “Justice delayed is justice denied.” Well, getting the right medicine to the right patient at the right time (as good a definition as any of “personalized medicine”) is health care justice — and the Supreme Court’s decision is going to be a barrier to achieving justice for all.

Peter J. Pitts, a former FDA Associate Commissioner, is President of the Center for Medicine in the Public Interest