Bart Stupak, a Michigan Democrat and a member of the House Energy and Commerce committee, tomorrow plans to offer an amendment to the House drug safety bill that would create joint authority for the Office of New Drugs and the Office of Suveilance and Epidemiology, according to sources.

The effort mirrors a recommendation by the Institute of Medicine and comes as the House moves closer to reauthorizing PDUFA, but without an independent office of drug safety. The idea is to strengthen the role of the OSE in the approval process, which should translate into greater post-marketing oversight. Here are the talking points:

Amendment Summary:
• The Stupak amendment would provide equality between the Office of Surveillance and Epidemiology and the Office of New Drugs to ensure drug safety is adequately represented at the FDA.

Background:
• The recent Institute of Medicine report on drug safety recommend joint post-marketing decision making between two offices within the FDA – the Office of Surveillance and Epidemiology and the Office of New Drugs (IOM recommendation 3.4).
• The joint decision making would give the Office of Surveillance and Epidemiology sign-off on actions taken as opposed to their present role of mere consultants to the Office of New Drugs in a post-market environment.

• This post-marketing decision making includes labeling changes, requiring additional post-marketing studies, and restrictions on distribution and use of drugs.
• By strengthening and formalizing the Office of Surveillance and Epidemiology’s role in the approval process, we are strengthening post-market safety.
• The Stupak amendment, which is in the IOM’s recommendations, is intended to ensure drug safety concerns are addressed in a timely manner.