NEJM & Drug Safety

Two editorials in this week’s NEJM on FDA matters:

• Bruce M. Psaty, M.D., Ph.D., and Sheila P. Burke, M.P.A., R.N., Protecting the Health of the Public — Institute of Medicine Recommendations on Drug Safety [free PDF linked from here].  Though Psaty does not disclose it in the article, he has served as plaintiffs’ expert counsel in many pharmaceutical products cases, including the Baycol litigation (in which I served as defense counsel).  I’m not sure if he’s involved in the Vioxx litigation discussed in the article.
• Gregory D. Curfman, M.D., Stephen Morrissey, Ph.D., and Jeffrey M. Drazen, M.D., Blueprint for a Stronger Food and Drug Administration [free PDF linked from here].

On a quick read, both seem generally pleased with the IOM recommendations regarding FDA reforms and seek greater flexibility than the binary approved/disapproved options the FDA currently possesses — i.e., greater post-approval powers.