American Society for Bioethics and Humanities – Call for Proposals

The 2013 ASBH Call for Proposals is now open. Details regarding the call can be found on the ASBH homepage  www.asbh.org). There you will find a link to the abstract submission site as well as a PDF containing the submission guidelines, including instructions for the Student Paper Competition. Abstracts will be accepted until 4:00 pm (CST), March 4, 2013.

Introducing Anup Malani

We’re pleased to introduce and welcome Professor Anup Malani, who will be guest blogging with Bill of Health for the month of January.  Anup is the Lee and Brena Freeman Professor of Law at the University of Chicago. He is also a Professor at the University of Chicago Pritzker School of Medicine, a University Fellow at Resources for the Future, Washington, D.C.; a Faculty Research Fellow at the National Bureau of Economic Research; and an editor of the Journal of Law and Economics and the Forum for Health Economics and Policy.

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Regulatory Concepts in the News, Part I: FDA Efficacy Standards for Old Drugs

By Patrick O’Leary

While reading some of the great articles from the health section of the New York Times over the holidays it struck me that such articles, in their need to be concise and accessible, often give only passing treatment to regulatory concepts that can be fundamental to the story. Accordingly, I thought it might be useful to write a series of posts digging down a bit deeper into some of the regulatory foundations of health stories that percolate up to public attention through the news. In this post I’ll begin by looking at an interesting point relating to drug efficacy standards raised by an article about a newly expensive (but decades-old) drug.

In Andrew Pollack’s “Questcor Finds Profits, at $28,000 a Vial” we read that a drug called Acthar, first approved by the FDA in 1952 and used primarily to treat rare infantile spasms, has in recent years become a very expensive and (for it’s maker) lucrative treatment for conditions ranging from multiple sclerosis to rheumatologic conditions. The article is worth a read for its thoughtful discussion of drug pricing, but it also makes passing reference to a some important regulatory concepts that bear further examination. One issue that particularly stood out to me was Pollack’s statement that Questcor, Acthar’s manufacturer, has been able to market the drug for a variety of uses “without being required to prove that the drug actually works” because it was “essentially grandfathered” into an anachronistic efficacy standard by being “approved for use in 1952, before the [FDA] required clinical trials . . . .” On first read, that sounds fairly alarming, so I thought it might be worthwhile to unpack the law around such “grandfathered” drugs a little. While it is true that FDA did not require proof of effectiveness for new drugs until lawmakers included this requirement in the Drug Amendments of 1962, it isn’t the case that pre-1962 drugs simply get a free pass on proving effectiveness. The truth, as one might expect, is somewhat more complicated. Continue reading