Decision Misprision

  • by: |
  • 06/28/2013

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

Per the Supreme Court’s recent 5-4 decision 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, Mr. Justice Alito opines that state law cannot trump federal laws regarding prescription medicines whose design has been approved by the Food and Drug Administration. So, the obvious first question is, why doesn’t Federal Preemption hold for innovator products. Will the Court revisit Wyeth v. Levine? Not likely.

And then there’s the more important question – that of patient safety. While there is no language in the Supreme Court decision on either bioequivalence or therapeutic interchangeability, the unintended consequence of their decision is that many payers and physicians, now that the burden of potential legal entanglements has been lifted, will now consider generics as “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, etc.

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.

It’s one of our nation’s most important and yet invisible problems. How to educate the various relevant publics on “bioequivalence?” Not that we were trying very hard before – but as we approach the reality of both small molecule patent expiry and biosimilars, the issue becomes less and less academic and more and more practical.

For example, how will the Court’s decision impact the INN 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 healthcare justice – and the Supreme Court’s decision is going to be a barrier to achieving justice for all.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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