Cyrus Dugger
F.D.A. Widens Safety Reviews on New Drugs
Some welcome and overdue changes:
F.D.A. Widens Safety Reviews on New Drugs
By GARDINER HARRIS
Published: January 31, 2007The Food and Drug Administration announced changes yesterday that were intended to ensure that marketed drugs are as safe as advertised, including the first effort to do a comprehensive assessment of the safety of drugs 18 months after introduction.
Doug Mills/The New York Times
Dr. Andrew C. von Eschenbach, commissioner of the Food and Drug Administration, in August.
The agency also announced the creation of an advisory panel to improve the way it announces safety worries and a collaboration with the Veterans Health Administration to track how real patients fare after taking drugs.
The F.D.A. plan is the latest effort to fix the agency after a series of missteps. In September 2004, Merck withdrew its arthritis drug, Vioxx, after a study showed that it doubled the risks of heart attack. About the same time, the agency announced that antidepressants cause some teenagers to think more about suicide. (link)
Posted at 2:40 PM, Jan 31, 2007 in Permalink | Comments (0) | TrackBack (0)
