FDA seen needing to fix post-market drug safety

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The U.S. Food and Drug Administration needs more staff and funding to fix its monitoring of drug safety after medicines are on the market, the Institute of Medicine (IOM) said on Friday.

The IOM, an independent group that studies scientific matters for the government, also suggested that drugs carry a “new drug” symbol during the first two years on the market to alert consumers that less is known about the risks and benefits.

Five years after a drug’s launch, the FDA should conduct a formal review of all available information about the product’s risks and benefits, the report also said.

The FDA requested the report in 2004 after the agency was criticized as being lax in its oversight of Merck & Co Inc.’s arthritis drug Vioxx and other medicines.

The authors said the FDA had taken steps to strengthen its post-approval system but “major obstacles” remained, including “a dysfunctional organizational culture, problems with credibility and public trust and the lack of adequate communication about, and limited public awareness of, drug risks and benefits.”

The report also recommended a six-year term for the FDA commissioner to add stability to the agency. Now, the term is an open-ended appointment by the president. The agency has had a permanent head for just 18 months since President George W. Bush took office five years ago.

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