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Drug Safety is goal of measure to revamp FDA fees, procedures
By Alex Wayne
Congressional Quarterly
April 23, 2007
A Senate committee approved legislation last week that would renew fees that pharmaceutical companies pay to the Food and Drug Administration and change the agency’s drug-safety procedures.
The Health, Education, Labor and Pensions Committee voted 15-5 to approve the bill, which would reauthorize a law governing fees drug companies pay to speed review of their products. Through the bill, Chairman Edward M. Kennedy, D-Mass., also attempts to address several recent scandals over dangerous medicines that critics say the FDA should never have approved, such as the painkiller Vioxx.
While all of the committee’s Democrats supported the bill, the vote exposed a rift among Republicans: Half of them opposed the legislation, saying it would have “unintended consequences” such as delays in drug development and a loss of access to drugs for patients.
Health and Human Services Secretary Michael O. Leavitt also has criticized provisions of the bill for the same reason.
The most contentious section is the meat of Kennedy’s drug-safety proposal: a system of reviewing new medicines that Kennedy calls “risk evaluation and mitigation strategy,” or REMS. Under the bill, the FDA could require manufacturers to submit products to the new procedure, which would require at a minimum FDA-approved labeling and periodic reviews of a drug’s safety record after it was marketed.
Leavitt says the procedure would duplicate work the FDA already does and would probably not improve drug safety.
The committee adopted three amendments, including a measure by Oklahoma Republican Tom Coburn that would subject “medical” marijuana products to FDA regulation, including safety and efficacy studies.
The committee’s debate presaged a bigger fight on the Senate floor, as Democrats and the committee’s ranking Republican, Michael B. Enzi of Wyoming, joined to defeat amendments proposed by Republicans that Kennedy argued would have gutted sections of the bill.
Some Democrats warned that they too would seek additional provisions in the legislation, including measures authorizing the FDA to approve generic versions of expensive biotech drugs and prohibiting baseless complaints that some brand-name drug companies file against generic competitors to their products.
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