If you had any lingering doubt that the new FDA would get tougher, here's some news for you: Commissioner Margaret Hamburg says she wants to move quickly on safety alerts, and she's promising more post-marketing safety studies. Plus, she plans to encourage doctors and patients to step up their reporting of adverse events. And don't use the "regulation-kills-innovation" argument on her. She's ready with a response. "FDA does play a critical role in fostering innovation," Hamburg told USA Today, but the agency also has "almost a sacred responsibility to assure safety in the use of these products."
Three wrap-ups of Hamburg's actions so far--and her intent going forward--are in the press today. And though each has a different focus, the common theme is vigilance. FDA has to be the safety cop, she says, because if it isn't, no one else can be. "There is no other agency like it," Hamburg told Bloomberg. "If we fail at our important mission, there really isn't anyone who is going to come in and backstop behind us."
So far, FDA staffers seem energized by Hamburg's takeover, analysts and other observers say. Hamburg and her deputy, Joshua Sharfstein, can take that good will and run with it. Apparently, they plan to do so. But as ex-FDAer Scott Gottlieb tells Bloomberg, changing the FDA will be a slow process. With 11,000 employees, the agency turns like an enormous ship--little by little. It could be a year before Hamburg's efforts pay off in evident ways. Will the Hamburg honeymoon last long enough? We'll have to wait and see.
- read the Bloomberg article
- see a profile in USA Today
- check out the story in the Wall Street Journal