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Gore Pro-Generic Campaign Platform Includes Citizen Petition Restrictions

Executive Summary

Vice President Gore is promising to address the potential for the FDA citizen petition process to be used to delay generic drug approvals if he is elected President.

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ANDA User Fee Creation Is Among Top NAPM Legislative Issues For 2000

The National Association of Pharmaceutical Manufacturers will press for the creation of generic drug user fees during the second session of the 106th Congress.

ANDA User Fee Creation Is Among Top NAPM Legislative Issues For 2000

The National Association of Pharmaceutical Manufacturers will press for the creation of generic drug user fees during the second session of the 106th Congress.

Claritin patent extension

Senate Health Committee Chairman Jeffords (R-Vt.) allows investigation of "pipeline drug" regulatory review delays to move forward at the General Accounting Office. GAO is in the process of reviewing whether FDA held up review of certain drugs, including Schering-Plough's Claritin, resulting in the loss of patent exclusivity time as the sponsors have argued. The report was requested by Sen. Leahy (D-Vt.) and other Democrats to examine whether the delays were caused by the sponsors themselves. GAO could not access FDA approval records without the authority of a committee chairman with jurisdiction (1"The Pink Sheet" Nov. 15, 1999, p. 10)

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