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Report: FDA needs to fix post-market drug safety
2006-09-22
The U.S. Food and Drug Administration needs more staff, funding and power over the drug industry to better police the safety of medicines after they reach the market, an Institute of Medicine panel said on Friday. In a report meant to address problems highlighted by the 2004 withdrawal of Merck & Co Inc.'s arthritis drug Vioxx, the Institute of Medicine also said it found a "dysfunctional" FDA structure that hinders the ability to protect public health. "FDA's reputation has been hurt by a perceived lack of transparency and accountability to the public, a legacy of organization changes that have not been completed or sustained, and an apparent slowness in addressing lack of (drug company) compliance," the report said. "Cultural changes are urgently needed to support a stronger, more systematic and more credible approach to drug safety," the report added. Acting FDA Commissioner Andrew von Eschenbach said the FDA had improved its oversight of drugs on the market but agreed more should be done. New measures will be announced in the coming months, he said. "I'm committed to taking additional steps, and we'll look to these initiatives recommended by the IOM," von Eschenbach told reporters. The report said efforts to study drug risks and benefits diminish after approval, largely because industry fees support pre-approval reviews. It called on Congress to provide a "substantial increase" in funding and staff to boost post-approval tracking. The FDA also needs stronger and clearer authority over drug manufacturers, such as the power to fine or seek injunctions against companies that fail to comply with requests for new warning labels or post-approval studies, it said. It also suggested that drug labels carry a "new drug" symbol during the first two years on the market to alert consumers that less is known about risks and benefits. The committee of experts that prepared the report said it favored a ban on consumer-directed advertising during that two-year period. 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 Institute of Medicine is an independent organization that advises the government on scientific matters. The FDA requested the study after it was sharply criticized as being slow to respond to side effects from various drugs, most notably Vioxx, which Merck pulled five years after approval because of a link to heart attacks and strokes. The Institute of Medicine panel said it found evidence to support claims that FDA officials had trouble managing scientific disagreements and downplayed some concerns by safety reviewers. Problems handling internal conflicts "have played an important role in damaging the credibility" of the agency, the report said. Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, agreed there were "some cultural issues" that should be addressed but said the agency still made sound, science-based decisions. The report recommended a six-year term, rather than an open-ended appointment, to add stability. Also, at least 60 percent of FDA advisory panels should be free of "significant financial involvement" with companies that may be affected by the decisions, the report said. FDA critics said the report echoed complaints they had voiced for the past two years and should spark prompt congressional and agency action. "Today there's no question left that we need to strengthen post-market surveillance in order to improve drug safety and save lives," said Senate Finance Committee Chairman Charles Grassley, an Iowa Republican. (Additional reporting by Susan Heavey)
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