Survey: FDA Scientists Question SafetyDec 16, 2004 | USA TODAY
FDA Adequately Monitors The Safety Of Prescription Drugs.
Two-thirds of Food and Drug Administration scientists surveyed two years ago lacked confidence that the FDA adequately monitors the safety of prescription drugs, a report released Thursday shows.
And 18% of the almost 400 respondents said they had been pressured to approve or recommend a drug despite reservations about its safety, effectiveness or quality.
The survey, conducted by the Department of Health and Human Services (HHS) Office of Inspector General, was partially released last year. An advocacy group released the full report, acquired via the Freedom of Information Act.
The survey's details come amid rising criticism that the FDA puts too much emphasis on getting drugs to market and too little on protecting consumers from unsafe or ineffective drugs. Sen. Chuck Grassley, R-Iowa, told a Senate hearing last month he feared "that the FDA has a relationship with drug companies that is too cozy."
The survey results also lend credence to surprising congressional testimony last month by FDA scientist David Graham. The associate director of science and medicine in the FDA's drug safety office said the agency didn't adequately weigh safety concerns of drugs on the market and was incapable of preventing another Vioxx-type incident. The painkiller was pulled from the market Sept. 30 by maker Merck after a study tied it to increased risk of heart attack and stroke with long-term use.
The Survey Also Found That:
31% of the scientists were only "somewhat confident" and 5% were "not at all confident" that final decisions on new drugs adequately assessed the drug's safety; 52% were mostly confident; and 13% were completely confident.
59% of them said the six months allotted to review some drugs wasn't enough time.
In a statement Thursday, the FDA said the study confirmed that, "overall," FDA medical reviewers believe their decisions appropriately assess drug safety and effectiveness and that debate is open and in-depth.
Still, the survey results "should cause a great deal of concern," says Arthur Levin of the Center for Medical Consumers, a New York-based patient advocacy group. But he says all fault doesn't lie with the FDA. Congress authorized it to collect fees from drugmakers to speed new drug approvals, blurring the line between those checking on drugs and those making them.
Grassley, a frequent FDA critic, said the survey helps "make an even stronger case" that a shake-up is needed at the FDA. That some scientists felt pressured, a survey statistic reported last year by consumer group Public Citizen, is noteworthy, says Jerry Avorn, author of Powerful Medicines and associate professor of medicine at Harvard Medical School. "Nearly one in five is a bad pattern," he says.
In contrast, HHS' report last year concluded that FDA scientists had "confidence" in FDA decisions. While noting that workload pressures may be harming the process, it said scientists did not believe they were ignoring key information or data in order to meet time goals. "We have no evidence of a public health concern nor did we seek to obtain such evidence," the report said.
Public Employees for Environmental Responsibility secured the survey and released it with the Union of Concerned Scientists.
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