Study Finds FDA Needs Safety Overhaul
"The government's drug safety system is seriously out of balance, devoting too much attention to approving new medications and not enough follow-up to uncovering risky side effects, a blue-ribbon scientific panel concluded in a major report released Friday.
Convened at the request of the Food and Drug Administration after a popular painkiller was linked to heart attacks, the experts in medicine, pharmacology, law and other fields issued a sweeping call for reform. Its 25 recommendations include establishing a fixed term for the FDA commissioner, restricting ubiquitous drug commercials and placing a special cautionary symbol on the packaging of newly approved medications.
The panel found "an imbalance in the regulatory attention and the resources available before and after approval" of new drugs, said Chairwoman Sheila Burke, a former Republican Senate staffer who now is chief operating officer of the Smithsonian. "Staff and resources devoted to pre-approval are substantially greater than those available post-approval."
Read the full article in the LA Times.