Product Specific Advisory Committee Meeting s

Tomorrow’s Federal Register is scheduled to carry a notice of a joint meeting of the Cardiovascular and Renal Drugs Advisory Committee with the Drug Safety and Risk Management Advisory Committee to be held on September 11, 2007.  The committees will discuss risks and benefits of Epogen, Procrit and Aranesp in the treatment of anemia for patients with chronic renal failure.

Next week, on July 30, there will also be a going meeting of the Endocrinologic and Metabolic Drugs Advisory Committee with the Drug Safety and Risk Management Advisory Committee to discuss the cardiovascular ischemic/thrombotic risks of the thiazolidinediones, with focus on rosiglitazone, as presented by FDA and GlaxoSmithKline.

The following day, on July 31, there will be a joint meeting of the Drug Safety Risk Management Advisory Committee, this time with the Gastrointestinal Drugs Advisory Committee – to discuss TYSABRI (natalizumab) biologic license application (BLA) 125104/33, Biogen Idec, Inc., for the
proposed indication of inducing and maintaining sustained response and remission, and eliminating corticosteroid use in patients with moderately to severely active Crohn’s disease with inflammation. 

Finally, on August 1, there will be a joint meeting of the Drug Safety and Risk Management Advisory Committee with the Dermatologic and Ophthalmic Drugs Advisory Committee to be briefed on
iPLEDGE, the risk management program for isotretinoin products. Presentations will provide updates on risk management activities for isotretinoin since the full implementation of iPLEDGE.

I think if I were a member of the Drug Safety and Risk Management Advisory Committee I would do two things – (1) ask for a raise, and (2) clear my calendar.  There is every indication that these joint meetings are going to become increasingly common as the ratio of risk to benefit continues to become so focused on the risk side.  And, while there is no real indication of what role the newly forming risk communication advisory committee is going to fill vis a vis the Drug Safety and Risk Management Advisory Committee (which has at least one risk communications specialist on it), but we may be looking at a day shortly where we have a joint meeting of three committees as opposed to two.  The meeting rooms are going to have to get much larger…

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