FDA Scientists Doubt Rx-Drug Approval Process

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

And more than a third have some doubts about the process for approving new drugs, the survey found.

The survey was conducted by the Department of Health & Human Services Office of Inspector General, but the full results were released to the public only after an advocacy group filed a Freedom of Information Act petition. It comes in the wake of safety concerns forcing removal from the market of Vioxx (search), an arthritis drug, and congressional testimony by Dr. David Graham, an FDA scientist, 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, an advocacy group that obtained the survey through a FOIA application. "These results show that many of Dr. Graham's colleagues share his concerns, but that those warnings are falling on deaf ears."

An FDA spokesman had no immediate response to a request for comment on the survey.

The survey sought the opinion of about 400 FDA scientists about the process of evaluating and approving prescription drugs. A majority of the scientists said they were "completely confident" or "mostly confident" about the FDA decisions about the safety and efficacy of drugs approved for sale. However, nearly a third, 31 percent, were only "somewhat confident" and five percent had no confidence in the safety decisions.

About 66 percent of the experts surveyed said they were not at all confident or only somewhat confident that the FDA adequately monitors the safety of prescription drugs once they are on the market.

"The survey raises significant issues about drug safety and ongoing monitoring of adverse health impacts of drugs in the marketplace," said Kathleen Rest, executive director of the Union of Concerned Scientists, a group that posted the full survey on its Web site. "The scientists' concerns warrant further investigation as Congress reviews drug approval practices at FDA."

"The FDA really needs to be reformed," said Rep. Bart Stupak (search), D-Mich., a Congressman who came to the defense of Graham after the scientist's testimony. Stupak said the FDA method of monitoring drugs now being sold is clearly inadequate.

"Once a drug is being sold, we're really at the mercy of the manufacturers," he said. "The FDA only learns of about 10 percent, if that, of the adverse effects from a drug on the market. There has got to be some changes."

Vioxx was pulled from the market on Sept. 30 by its manufacturer, Merck & Co., after a study indicated the popular pain reliever doubled the risk of heart attacks and stroke when taken for longer than 18 months.

The survey also asked the scientists if they had ever been pressured to approve a drug even though they had reservations about its safety, efficacy or quality.

Of 360 responses, 297, or 82 percent, of the scientists said they did not feel they had been pressured. Sixty-three, or 18 percent, said they did come under such pressure.

"Eighteen percent does not bode well," said Roose. "We would expect that in an agency that is protecting the public health that the number of scientists not feeling pressure should be 100 percent. That is a matter of concern."

The survey was summarized in a report released last year by the HHS office of inspector general. That summary did conclude that FDA scientists felt under constant pressure to meet time constraints on drug evaluation and that 58 percent felt that six months allocated for some drug reviews was inadequate. The OIG report, however, said "we have no evidence of a public health concern nor did we seek to obtain such evidence."

Officials at the Union of Concerned Scientists and at the Public Employees for Environmental Responsibility said requests for the full report were ignored by the FDA and the HHS until PEER filed the FOIA application. Even Rep. Stupak said he had been stymied in his efforts to get a copy of the full report.