Drug safety issues raised in FDA official’s testimony

Share this article:
An FDA scientist raised questions about the safety of five marketed drugs while testifying Thursday on Capitol Hill, but his superiors and
the pharma companies that market these drugs quickly defended their safety.
David Graham, a reviewer in the FDA's Office of Drug Safety, also
noted at the hearing that he believes drug regulators at the agency are "virtually incapable of protecting America" from unsafe drugs. The five drugs on the market whose safety needs "to be seriously looked at" are: Crestor, Bextra, Meridia, asthma drug Serevent and Accutane, an acne treatment from Roche that currently carries a safety warning for pregnant women.
"We are faced with what may be the single greatest drug safety catastrophe in the history of this country or the history of the world," Dr. Graham told the Senate Finance committee, which called the meeting to examine the recent recall of Merck's Vioxx. Steven Galson, director of the Center for Drug Evaluation and Research and a physician, subsequently called Dr. Graham's data and testimony "junk science" and "irresponsible," according to The New York Times. And Sandra Kweder, deputy director of the office of new drugs, added that Graham was not describing "the F.D.A. that I know," according to the newspaper report. She said she did not believe the five drugs have safety issues "more concerning than any others." The unusual open debate among FDA officials came during the hearing called by committee chairman Sen. Charles Grassley (R-Iowa),who has been reviewing the FDA's role in monitoring Vioxx's safety. Merck, as reported, withdrew Vioxx after a study it sponsored found that use the drug doubled the risk of heart attack
or stroke.
Graham noted in his testimony that he and colleagues have recommended 12 drugs be withdrawn during his tenure at the FDA, and only two of those are still marketed.
Share this article:
You must be a registered member of MMM to post a comment.

Next Article in Business Briefs

Email Newsletters

MM&M Future Leaders

Register now

Early bird $1,950 before 31 October 2014

*Group discounts available on request 


Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Business Briefs

Novartis said to be stepping out of HCV

Novartis is said to have relinquished rights to an investigational hep. C treatment, signaling its exit from the therapeutic space, according to a former partner's announcement.

Monday Moves: September 15

Hires and promotions for manufacturers, regulatory and agencies

Kantar acquires Evidências, expands Brazilian presence

The company's acquisition signals the growing importance of understanding the Brazilian healthcare market and evidence-based healthcare management services.