NAPM seeks to keep antibiotics out of Waxman/Hatch exclusivity procedures if Sec. 507 is repealed.

Executive Summary

NAPM HOPES TO KEEP ANTIBIOTICS OUTSIDE WAXMAN/HATCH EXCLUSIVITY provisions, David Weeda of the Washington, D.C. law firm Olsson, Frank & Weeda told the National Association of Pharmaceutical Manufacturers annual meeting Jan. 31 in Naples, Fla. Legislation to repeal the separate regulation of antibiotics under FD&C Act Sec. 507 is expected to be reintroduced this year, Weeda noted. NAPM wants to ensure that such a repeal does not overturn the exemption of antibiotics from the Waxman/Hatch amendments.