The Unapproved Drugs Conundrum

In recent years there have been a few high profile situations in which the price of a medicine has jumped sharply and suddenly, after decades of availability at a much lower price.  In some of these cases — like the case of gout treatment colchicine, which went from 10 cents to five dollars per pill in 2011 — the sudden price increase relates to FDA’s “unapproved drugs initiative.”  This refers to the agency’s approach to removing unapproved new drugs from the U.S. marketplace.

This blog entry explains the back story and the public policy conundrum that merits some attention.

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The Logical Outgrowth Doctrine and FDA’s Intended Use Revisions

Cross-Posted on Notice & Comment

In January FDA published a controversial revision to its regulations defining a product’s “intended use” that, among other things, has raised an interesting logical outgrowth question. “Intended use” is an important concept in FDA law because a product’s intended use—judged by the “objective intent of the persons legally responsible for the [product’s] labeling”—can be crucial to determining whether a product is a drug or device subject to FDA oversight at all, and whether an FDA-authorized drug or device is in compliance with FDA requirements. (Readers can find more about “intended use” generally, and the background behind the current controversy, here). Because “intended use” is so important in the FDA world, it should come as no surprise that stakeholders that disagree with the revised definition in the January final rule—which has yet to go into effect—have lodged both procedural and substantive arguments against the revision (see, e.g., here and here).

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NASEM Report on Pain Management and the Opioid Epidemic

Disclosure: I served as a consultant to the Committee on Pain Management and Regulatory Strategies to Address Prescription Opioid Abuse.

Last year, FDA asked the National Academies of Sciences, Engineering, and Medicine (NASEM) to appoint a committee to study the role of opioids in pain management and the opioid epidemic, and, among other things, to provide the agency with recommendations on the options available to it to address the epidemic. Today that committee’s report was released.  As noted above, I served as a consultant to the committee—and I will let the report speak for itself. But there is a lot in the report that may be of interest to the FDA law and policy crowd, and I look forward to hearing reactions to the report and the recommendations included in it.

Could FDA Enforce the “Requirement” to Provide the Biosimilar Marketing Application ?

I am writing again about the Supreme Court’s June 12 ruling that Amgen was not entitled to a federal injunction ordering Sandoz to share its biosimilar marketing application and manufacturing information.  The Court’s opinion refers ten times to providing those materials as “required” or a “requirement” (Slip Op. at 2, 4, 7, 9, 10, 13, 13, 14, 15, and 15).  What does this mean, as a practical matter?

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