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SENS. KENNEDY, HATCH ASK FOR MORATORIUM ON ORPHAN APPROVALS

Executive Summary

SENS. KENNEDY, HATCH ASK FOR MORATORIUM ON ORPHAN APPROVALS, and, in effect, the EPO approval, until June 30. Kennedy (D-Mass.) and Hatch (R-Utah) want to use the first six months of 1989 to review provisions of the law and consider amendments. "From now until June 30, 1989, where there are multiple companies that have submitted completed NDAs for the same orphan drug, we urge you to proceed with complete review of all applications," the senators wrote. However, they also urged FDA "within statutory authority" to "withhold award of market exclusivity until the above date." The senators pointed out that "a notable example where such possibility exists involves EPO [erythropoietin]." Amgen has publicly stated that it expects FDA to approve its marketing application for EPO within the first quarter of 1989. The company filed the application in November 1987. "We plan to re-examine the seven-year exclusivity provision of the Orphan Drug Act early in the 101st Congress," the legislators said. Genetics Institute, which has filed a marketing application for an EPO product to be marketed by Upjohn, is based in Cambridge, Mass.; HGH developer, Serono, is located in Norwell, Mass. Hatch was asked by former Sen. Laxalt (R-Nev.), lobbying on behalf of Nordisk, to address human growth hormones in orphan drug legislation; he was asked by former Sen. Hawkins (R-Fla.), on behalf of Genentech, not to. The two senators agreed to send their letter to FDA last fall during congressional negotiations surrounding the passage of the veterinary ANDA/patent restoration bill. Sen. Metzenbaum (D-Ohio) blocked the legislation but lifted his objection with the understanding that Kennedy and Hatch would write the agency about plans to amend the Orphan Drug Act. Kennedy and Hatch told FDA they "are aware of the need to maintain the legitimate and necessary incentives" that have led to the marketing of more than 240 orphan products. However, "if the current seven-year exclusivity is maintained, prices to consumers may remain high." Both are said to be interested in reviewing not only the act's exclusivity provisions, but also marketing protections and patent provisions available for biotechnology products. A Nov. 21 meeting on Capitol Hill failed to reach a consensus on an acceptable way to amend the act. Participants included representatives of Sens. Kennedy, Hatch, and Kassebaum (R-Kan.), Rep. Waxman (D-Calif.), FDA, the Institute of Medicine, the National Organization for Rare Disorders, the Pharmaceutical Manufacturers Association, the Industrial Biotechnology Association, the Generic Pharmaceutical Industry Association, Lilly, Genentech, and Serono. Potential approaches included: limiting exclusivity based on sales volume or at FDA discretion; extending exclusivity based on price reductions; providing for shared exclusivity; and increasing intellectual property protections.
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