GROWTH HORMONE AND EPO LEGISLATION TO BREAK ORPHAN EXCLUSIVITY
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.
You may also be interested in...
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Shire Hopes To Sow Future Deals With $50M Venture Fund
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth