HealthLawProf Blog

Editor: Katharine Van Tassel
Case Western Reserve University School of Law

Friday, December 17, 2004

FDA: Crisis in Confidence?

Fda As reported by the AP yesterday (courtesy of Yahoo!News),

About two-thirds of Food and Drug Administration scientists are less than fully confident in the agency's monitoring of the safety of prescription drugs now being sold, according to an FDA internal survey.

Also, more than one-third of those scientists have some doubts about the process for approving new drugs, the survey found.

The survey was conducted by the Health and Human Services' Office of Inspector General. Complete results were released to the public only after an advocacy group filed a Freedom of Information Act request. The release comes in the wake of safety concerns forcing removal from the market of Vioxx, an arthritis drug, and congressional testimony by an FDA scientist, Dr. David Graham, that the agency mishandled safety concerns about five other drugs.

"By all appearances, FDA would rather be sorry than safe," said Rebecca Roose, director of the Public Employees for Environmental Responsibility, which obtained the survey through the FOIA request. "These results show that many of Dr. Graham's colleagues share his concerns, but that those warnings are falling on deaf ears."

An agency spokesman, Brad Stone, said the survey was commissioned in 2001 and was two years old. He said the survey confirmed that FDA medical reviewers believe the drug decisions "appropriately assess the safety and effectiveness of drugs and the process allows for open in-depth scientific debate."


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Hi Professor Mayo,

I think that the FDA is a huge obstacle to treating people. Plaintiff's personal injury lawyers are even worse. When has a drug or treatment NOT had risks? I confess that I find plaintiff's personal injury lawyers to be mostly disgusting.

I predict that the more revelations like this that are characterized by idiotic and poorly educated journalists as "scandals" the fewer innovations and breakthroughs in medicine we will have.

Stories and criticisms like this make me want to establish a real "Galt's Gulch".

Posted by: Sue Bob | Dec 17, 2004 9:35:22 PM

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