Legislation expanding the Food and Drug Administration's drug-safety oversight won final congressional approval, but its impact on the pharmaceutical industry will depend largely on how the agency opts to use its new powers.
The bill, which the Senate passed yesterday following House approval Wednesday, increases the fees that drug makers pay the FDA to review their drugs and allots a portion of the money for the agency to monitor the safety of drugs after they go on the market.
It also solidifies the agency's authority to mandate changes to drug labels, require additional safety studies and limit the distribution of medications when safety concerns arise -- powers that have existed informally but haven't always been clearly delineated.
More at the WSJ
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