Generic drug approvals during GATT transitional period would be allowed by Sen. Pryor's S 1191.

Executive Summary

GENERIC FIRMS COMPLETING "PENULTIMATE STEPS" OF ANDA PROCESS prior to June 8, 1995 would be permitted to market a product during the patent extension resulting from the 20-years-from-filing system adopted in the Uruguay Round Agreements Act under legislation introduced by Sen. Pryor (D-Ark.) Aug. 11. The "Consumer Access to Prescription Drugs Act" (S 1191) defines the "substantial investment" that would allow marketing during the URAA transitional period as: "the development of a product formulation and the manufacture of an experimental batch of a drug that becomes the subject of an application, or the initiation of stability or bioequivalency studies by an applicant."