Disturbing News on Pharma's Lack of Post-Marketing Review

According to a recently released report from Rep. Ed Markey ((D)Mass.), most pharma companies using FDA’s “accelerated approval” process (for drugs for patients with life-threatening illnesses) have failed to perform the legally-required post-marketing studies after their drugs have begun being marketed to physicians and consumers. Half of the companies have not even begun the required studies, even though on average they’ve been marketing the approved drugs for more than a year. The FDA has failed to respond to this situation. Markey’s report, courtesy of National Health Lawyers Assoc., is at: http://www.healthlawyers.org/hlh/docs/Markey_fdarpt.pdf

Thanks for this informative update go to Steve Latham, Professor of Law and Director, Center for Health Law & Policy, Quinnipiac University School of Law, Lecturer in Business Ethics and Law Yale School of Management.  [bm]