Speed, safety equally important for FDA

The Wall Street Journal is reminding the FDA that it’s not just there to protect the public, but also to get new treatments into doctor’s hands. Phamacyclics CEO Richard Miller decries current FDA policies aimed at “discouraging the development of groundbreaking treatments.” Patient advocates have also voiced their frustration with FDA in WSJ’s pages. The public at large still seems more worried about making drugs safer rather than having more drugs available. Still, patient groups and physicians have at least scored some wins with drugs already on the market: Witness Tysabri and Avendia’s recent positive advisory panel decisions and the new CMS guidelines for coverage of Amgen’s and Johnson & Johnson’s anemia drugs, which are stricter than before but not as bad as was anticipated. Clearly, it’s easier to argue for a drug’s benefits when more data is available, but Miller points out that waiting for that data is not always in the patients’ best interest. A true weighing of risks and benefits needs to occur.

- read the editorial from more (WSJ sub req.)