Worried that the Obama administration would usher in a no-tolerance policy toward drug side effects? Well, you can rest easy now. An analysis of Obama's FDA shows that the number of new "black box" warnings dropped by almost half in 2009--to 31 from 56 in 2008.
The new FDA did step up its use of "early communications" to reach the public more quickly and effectively. And it went after more companies producing fake or dangerous products.
The overall picture? A "moderate" approach to regulation--which should relieve some industry anxiety--and new "confidence and certainty" at the agency, the Associated Press reports. "The rank-and-file staffers are now able to move with confidence that the agency has their back," one analyst tells the AP.
- get the AP news [1]
Related Articles:
Changes for a faster, more aggressive FDA [2]
Ex-FDA chief tapped to critique agency [3]
Hamburg 'honeymoon' could aid FDA reform [4]
Can a tough, persuasive Hamburg overhaul FDA? [5]
Shift in enforcement halves FDA warnings [6]
Links:
[1] http://finance.yahoo.com/news/FDA-drug-approvals-mostly-apf-3727430255.html?x=0&.v=5
[2] http://www.fiercepharma.com/story/hamburg-honeymoon-could-aid-fda-reform/2009-08-07
[3] http://www.fiercepharma.com/story/ex-fda-chief-tapped-critique-agency/2009-09-24
[4] http://www.fiercepharma.com/story/hamburg-honeymoon-could-aid-fda-reform/2009-06-17
[5] http://www.fiercepharma.com/story/can-tough-persuasive-hamburg-overhaul-fda/2009-05-07
[6] http://www.fiercepharma.com/story/shift-enforcement-halves-fda-warnings/2008-06-09