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ORPHAN DRUG AMENDMENTS: CONGRESS DISCUSSING BIO PROPOSAL

Executive Summary

ORPHAN DRUG AMENDMENTS: CONGRESS DISCUSSING BIO PROPOSAL, including whether, how or when to proceed with legislation. As of June 25, members expected to take an active interest in orphan drug amendments had not agreed to a plan or a timeframe for legislative action; however, it is possible they will jointly introduce an orphan bill. The Biotechnology Industry Organization, comprising member companies from the merging Industrial Biotechnology Association and the Association of Biotechnology Companies, submitted a proposal in late May to Sens. Kennedy (D-Mass.), Kassebaum (R- Kan.), Metzenbaum (D-Ohio) and Hatch (R-Utah) and Reps. Waxman (D- Calif.) and Bliley (R-Va.). The BIO proposal would reduce orphan market exclusivity to five years from seven but allow orphans with patient populations of less than 100,000 to apply for five-year extensions. It also would establish a four-year market exclusivity period for biotech products, regardless of the size of the patient population ("The Pink Sheet" June 21, T&G-7). Members of Congress who have read the proposal reportedly are impressed that the industry made a bona fide effort to develop a draft that meets the satisfaction of most companies and is worthy of congressional consideration. While the BIO proposal, were it enacted, would be a boon to the biotech industry as a whole, at least two BIO members, Serono and Novo Nordisk, oppose the proposal. They reportedly consider the biotech market protection section a potential new barrier to competition for smaller firms. Both firms have human growth hormone products that have been blocked by Lilly's orphan exclusivity. The National Organization for Rare Disorders will weigh in against a number of provisions in the BIO proposal. Primarily, NORD opposes using the Orphan Drug Act as a legislative vehicle for providing market protection for unpatentable biotech products. Alternatives include attempting to amend patent law or amending the the 1984 Waxman/Hatch Act, which excluded biologics from provisions of market protection from ANDA competition during the first five years after approval of new drug and antibiotic compounds. NORD also opposes BIO's proposed criteria for true orphans eligible for extensions of market exclusivity, such as the number of sponsors overseas and patient populations of less than 100,000. A number of true orphans that are reasonably priced have patient populations of nearly 200,000 patients, NORD Executive Director Abbey Meyer contended. In addition, diseases that are rare in this country, like leprosy, may have many companies sponsoring research overseas, where the condition may be more prevalent.
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