WASHINGTON, April 24 (UPI) -- A U.S. government report says the Food and Drug Administration has unclear drug safety policies and sometimes excludes safety experts from important meetings.
The Government Accountability Office inquiry was requested by Congress in 2004 after the sudden withdrawal of the blockbuster painkiller Vioxx, which was found to increase the risk of heart attacks and strokes in long-term users.
The GAO concluded that the agency's entire system for reviewing the safety of drugs already on the market is too limited and broadly flawed.
Since 2000, a total of 10 drugs have been withdrawn by their manufacturers for safety reasons.
The report found that the Office of Drug Safety, which monitors reports of emerging safety risks, at times made recommendations that were ignored by the larger and more influential Office of New Drugs. The drug safety office has had eight directors in the past 10 years.
Alastair Wood of Vanderbilt University, a prominent voice on the FDA's advisory panel on drug safety and risk management, said the GAO report "confirmed a lot of what people have been saying for some time."
GAO: FDA falls down on drug oversight
Agency needs to improve scrutiny of products after approval
WASHINGTON (MarketWatch) -- The Food and Drug Administration is doing an inadequate job of monitoring the safety of drugs after they're approved for the market, congressional investigators said in a study released Monday. "FDA lacks clear and effective processes for making decisions about, and providing management oversight of, post-market safety issues. The process has been limited by a lack of clarity about how decisions are made and about organization roles, insufficient oversight by management, and data constraints," the Government Accountability Office said, in its report.
The report recommended that the FDA be given the authority to require drug-makers to conduct studies on products already approved for the market.
The investigation was requested by Senate Finance Committee Charles Grassley, R-Iowa, and House Energy and Commerce Committee Chairman Joe Barton, R-Texas. It was prompted by complaints that FDA was slow to require potentially dangerous drugs, including Merck's Vioxx, to be pulled from the market. Merck Co.
MRK34.24, -0.13, -0.4%) yanked Vioxx from the market in 2004 after a clinical study showed that patients who took the drug for 18 months or longer ran a higher risk of suffering a heart attack or stroke. Vioxx, an anti-inflammatory agent, was used primarily to treat arthritis and injuries. Grassley released the study at a Capitol Hill news conference, where he blasted the FDA for failing to address long-standing complaints.
"We get press releases listing accomplishments rather than a meaningful revamping of the way things work inside the FDA. My staff investigators continue to hear from FDA employees who believe in their agency and ... want to do the right things, but experience intimidation, suppression and reassignments when they raise concerns about the integrity of the FDA's work," Grassley said. In a response included with the GAO report, the FDA's Center for Drug Evaluation and Research said the report was "well done" and found that the "conclusions reached are reasonable and consistent with actions we already have underway or planned."
Grassley, whose panel oversees the federal Medicare and Medicaid programs, urged passage of legislation that would give FDA scientists authority to conduct an independent, post-market review of drugs. He also called for action on a separate bill that would establish a mandatory clinical-trials registry.
Neither piece of legislation has moved out of the Senate Health, Education, Labor and Pensions Committee, which has direct oversight jurisdiction for FDA.
"This report is extremely helpful in evaluating the procedures used by the FDA to keep tabs on drugs once they are approved and allowed on the market. It is critical that we maintain public confidence in the FDA's ability to protect the public health," said Senate Health, Education, Labor and Pensions Committee Chairman Mike Enzi, R-Wyo. Enzi said that he plans to soon introduce "comprehensive drug legislation" with Sen. Edward Kennedy of Massachusetts, the committee's senior Democrat.