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Executive Summary

GROWTH HORMONE AND EPO LEGISLATION TO BREAK ORPHAN EXCLUSIVITY held by products already on the market is sought by the Association of Biotechnology Companies in a resolution adopted by the association's board Oct. 5. The resolution calls for Congress to permit marketing of additional versions of biosynthetic human growth hormone and erythropoietin, which, ABC says, are cases where "the Orphan Drug Act has been misused to obtain market exclusivity for products which are clearly not orphans, and would have been developed even without the Orphan Drug Act." ABC also asks Congress to consider ways to make the Act's tax incentive provisions "meaningful to small innovator companies which have not yet achieved profitability." The call for changes in the orphan act probably indicates a renewed hope for Congressional attention. That hope is based in part on an attempt to slip a change into the budget reconciliation act by Sen. Kennedy (see related item above) and the continued public attention to the high prices being charged for some orphan monopoly products, such as aerosolized pentamidine ("The Pink Sheet" Oct. 2, TG-5). Product-by-product changes to the orphan act, however, would appear to be a difficult approach to reform and one that could quickly unwind all the incentives. ABC members Novo Nordisk, BioGeneral and Serono hope to market human growth hormone. ABC member firms Upjohn and Genetics Institute have developed erythropoietin products. A second major biotech interest group, the Industrial Biotechnology Association, has opposed changes to the Orphan Drug Act. ABC recently appointed a new executive director to handle its Washington affairs. Pamela Bridgen, PhD, assumed the post September 18. The National Organization for Rare Disorders supports action to correct abuses of the Orphan Drug Act. NORD Executive Director Abbey Meyers acknowledges that some members of Congress consider Genentech's Protropin and Lilly's Humatrope excessively priced. However, noting that Amgen Chairman George Rathmann cleared Epogen pricing with the Health Care Financing Administration before marketing, NORD does not support the ABC position with respect to erythropoietin.

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