Claritin patent extension

Executive Summary

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)