Lawmakers approve additions to the FDA Modernization Act

August 1, 1997

Pharmaceutical Representative

The Senate Labor & Human Resources Committee voted 14-4 to approve amendments to S830, the FDA Modernization Act of 1997.

The Senate Labor & Human Resources Committee voted 14-4 to approve amendments to S830, the FDA Modernization Act of 1997.

If passed by the Senate, the revised legislation will require the FDA to designate officials in nearly all centers to encourage prompt reviews of supplements and work with sponsors to develop supplemental applications. The FDA will also be required to issue guidelines on supplemental data requirements and collaborate with other government health agencies on new uses for therapies.

Other amendments to the bill included a clarification of the FDA's ability to approve a drug based on one good study plus supporting evidence obtained before or after the investigation, and a provision that allows pharmaceutical companies to withhold trial data from a Health and Human Services database if it hinders timely enrollment of subjects.

Earlier in June, Sens. Edward Kennedy (D-MA) and Jim Jeffords (R-VT) debated how the bill would address the FDA's right to enforce post-marketing research requirements for sponsors of drugs granted accelerated approval. Both agreed to seek compromise before the bill is presented to the Senate.

The Senate never voted on the reform bill in 1996, but probably will before Aug. 1 because the bill includes the Prescription Drug User Fee Act. Without a promise from the Senate that the act, which expires Sept. 30, will be renewed, the FDA will have to give layoff notices to hundreds of reviewers on Aug. 1. PR

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