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Report slams FDA safety procedures

US regulator is failing to adequately address drug safety issues, says GAO

The US Food and Drug Administration (FDA) has come under fire from government auditors for failing to adequately handle drug safety issues, reopening the debate on whether new legislation should be introduced to tighten up the US drug regulatory system.

A report by the Government Accountability Office (GAO), the auditing arm of congress, said that while drug safety experts often raise alarms about certain drugs, they sometimes feel that their recommendations are ignored by the regulatory agency.

The FDA came under severe criticism for its handling of the withdrawal of Merck's COX-2 in 2004; many commentators felt the agency was too slow in its review of Vioxx's potential health problems. Since 2000, pharma firms have withdrawn 10 drugs from the US market after they were linked to deaths and other injuries in patients taking them.

On occasions top FDA officials excluded drug safety specialists from presenting findings at public hearings, while bureaucratic tensions between those officials who approve drugs and those who assess their safety are common, the report said.

ìFDA lacks clear and effective processes for making decisions about, and providing management oversight ofî issues involving the safety of popular medicines once they are on the market, the report states.

The GAO report focused on the relationship between the FDA's Office for New Drugs, which reviews medicines pre-launch and the Office of Drug Safety, which deals with post-approval safety. It said the latter served as a ìconsultantî to the former with ìno independent decision-making responsibilityî.

After the Vioxx withdrawal, the FDA formed the Drug Safety Oversight Board, a body that had greater powers to act on emerging drug safety issues. However, the GAO made clear that it considers the FDA's actions insufficient, saying that while the new board may help provide greater oversight of high-level safety decisions, ìit does not address the lack of systematic tracking of ongoing safety issuesî.

The GAO report was presented by Senator Charles Grassley, the Iowa Republican who is chairman of the Senate Finance Committee, and Joe Barton, head of the House Energy and Commerce Committee.

In a statement, Grassley said the GAO report showed that ìthe FDA's problems are systemic and cultural, not isolated or easily fixedî.

Barton was less scathing, saying the report ìshows that the drug safety system is not in crisis, but the FDA'S process may need some fine-tuningî.

In a statement, the FDA responded by saying it is already ìleading a comprehensive and timely effort to transform the methods our medical and scientific staff use to manage safety issuesî. The agency added that ìmany significant reforms have already taken shape and are leading to improvements in how we communicate drug benefit and safety informationî.

The GAO has recommended that Congress vote to give the FDA power to force pharma companies to undertake or complete safety studies of medicines already on the market, saying the agency currently lacks ìbroad authorityî to do so.

Alastair Wood of Vanderbilt University, who sits on the FDA's advisory panel on drug safety and risk management, called for more sweeping changes, including the creation of a drug safety board independent of the agency.

ìClearly, independence is not shuffling the deck chairs on the Titanic, which is what the FDA did,î he said.

30th September 2008


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