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Senate votes to speed up FDA approval process; House to vote this week posted 9-28-97 The House of Representatives is expected to vote this week on a bill designed to speed up the Food and Drug Administration’s approval process of drugs and medical devices. The Senate passed a similar version of the bill Sept. 25 by a vote of 98-2. The Senate bill received vigorous support after being tied to the renewal of the popular Prescription Drug User Fee Act of 1992, which expires Sept. 30. It requires pharmaceutical companies to pay the majority of costs for drug safety and effectiveness reviews. The fees have enabled the agency to hire 600 workers to help speed up drug approval. The Senate legislation also seeks to cut the approval time for medical devices by allowing outside experts accredited by the agency to review some types of devices. High-risk devices and devices implanted in the human body for a year or more would still go through an internal FDA review. The Senate bill would also: * give some seriously ill people access to experimental drugs; *create incentives for the development of labeling standards for children’s medication; and *give companies greater latitude to supply physicians with product information not approved by the FDA. |
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