Anyone who keeps tabs on pharma news has noticed that the FDA is on a mission these days. The agency, long criticized as too slow and too cozy with industry, has stepped up its game since the Obama administration took over.
More warning letters--yes, more than 100 last year, compared with 21 in 2006. And more surveillance, too: "I think the general approach has clearly been more warning letters, more regulatory activity, a much more rigorous approach to regulating products on the market," Kenneth Kaitin, director of the Tufts Center for the Study of Drug Development, tells McClatchy-Tribune.
That new activity hasn't gone unnoticed in political circles. As the news service reports, one Bush administration FDA official has called the agency "overzealous" in some quarters--although he had to admit the "it's been mainly science" prompting the agency to act. And American University's Lewis Grossman calls the new FDA "cautiously energetic."
- read the McClatchy-Tribune story