A Drug-Safety Board
Posted on: Friday, 15 April 2005, 18:00 CDT
The Food and Drug Administration's new drug-safety board is a well-intentioned response to shortcomings in the agency's drug- review system. But it is likely to bring about only modest improvements.
The board is to be made up of government scientists, many of them from the FDA. It will be able to air information pointing to problems with drugs. But it cannot force drugs from the marketplace. Nor can it require pharmaceutical companies to perform new tests. Another serious drawback is that little new money is being allotted to help researchers sort through large health-care databases such as Medicare's, a potential gold mine of drug-safety data.
The FDA seems to understand that it must be more open about the information it is collecting. A recent spate of controversies regarding particular drugs, among them certain antidepressants and painkillers, has left the public mistrustful. But as long as pharmaceutical companies continue to foot the bill for so much of the testing that goes on, the agency will be under pressure to keep some information secret. This same pressure is likely to affect the new advisory board.
Sen. Charles Grassley (R.-Iowa) is working on legislation aimed at making the drug-safety board more independent, and firmly insulated from the part of the FDA that approves new medicines. He also envisions giving the board greater authority. His proposals bear watching. Now is not the time to spend lavishly on new programs, but putting at least some extra resources into drug safety seems warranted.
Source: Providence Journal
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