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GPIA TO PURSUE OVERSEAS GENERIC SUPPLY ISSUE WITH USTR

Executive Summary

GPIA TO PURSUE OVERSEAS GENERIC SUPPLY ISSUE WITH USTR in a meeting tentatively scheduled during October, Generic Pharmaceutical Industry Association Chairman William Haddad reported at a Sept. 15 press conference in Washington. Haddad maintained that GPIA has had previous meetings with the U.S. Trade Representative staff about support for permitting pre-expiration testing of pharmaceutical ingredients which are nearing the end of their patent lives. The USTR office is headed by Mickey Kantor. "We have met with the staff," Haddad said, but "we have not been successful in changing policy. We hope that in October they will meet with us." Haddad noted that the generic industry has had the support of Sen. Pryor (D-Ark.), who wrote to the USTR in March ("The Pink Sheet" March 29, T&G-5). Haddad characterized overseas patent extension laws that prevent pre-expiration testing as a "brilliant" strategy to prolong effective patent life in the U.S. He called it the "most serious threat" to the generic industry's ability to compete with off-patent brands. Noting that the USTR has been involved in larger issues, Haddad said that the Clinton Administration has left in place a position "physically" on the side of efforts to restrict the import of raw materials for the generic industry. "We have vigorously pursued a change in policy; it has not yet been forthcoming," the GPIA exec reported.
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