Risky Business

J0382660Last week, the FDA announced the formation of a new Risk Communications Advisory Committee that will differ from the existing Drug Safety and Risk Management Advisory Committee, presumably by focusing solely on communication of risk.

Yesterday and today, the FDA has been holding a public hearing on MedGuides – a risk management tool that is prescribed by FDA for certain drugs.  A MedGuide is an FDA-approved written patient information that may have serious and significant health concerns. The agency is seeking "information and views from interested persons on specific issues associated with the development, distribution, comprehensibility, and accessibility of Medication Guides…"  The FDA Web site also maintains a list of drugs with MedGuides

One June 25 and 26, the FDA will hold yet another public workshop, this time on "Implementation of Risk Minimization Action Plans (RiskMAPs) to Support Quality Use of Pharmaceuticals: Opportunities and Challenges.”  It would seem that people who are interested in getting on the Risk Communications Advisory Committee might do well to attend, as well as all those who are thinking of the new role that RiskMAPs may play in the future, especially given this language in the Federal Register Notice – "This meeting is an initial step that is part of FDA’s commitment to monitor the
performance of RiskMAPs consistent with the goal articulated in the proposed PDUFA IV agreement to undertake regular follow up of these plans."

All of this, meanwhile, is leading up to the July 30 Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee with the Drug Safety and Risk Management Advisory Committee to talk about Avandia and diabetes medications. 

As Sergeant Phil Esterhaus used to say on Hill Street Blues – "Let’s be careful out there."

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