WASHINGTON (CNI)--A US House committee has approved a bill to double research funding on "orphan" drugs used in government-supported clinical trials, sources told CNI Friday.

The bill, cosponsored by Representatives Mark Foley (Republican-Florida) and Henry Waxman (Democrat-California), won voice vote approval Thursday from the House Energy and Commerce Committee. It would authorise $ 25m/year (Euro25.5m) in fiscal 2003 and succeeding years for development of orphaned drugs used in clinical trials supported by the US Food and Drug Administration (FDA). In fiscal year 2002 that funding level was at $ 12m.

The funding is designed to encourage private-sector testing of new drugs, diagnostics, and medical devices that show promise in the treatment of illnesses that do not afflict enough people to make development of new products profitable without such assistance.

The FDA orphan drug program is directed at illnesses that affect small populations, such as Huntington's disease, amyotrophic lateral sclerosis (Lou Gehrig's disease), Tourette syndrome, Crohn's disease, cystic fibrosis, cystinosis, and Duchenne muscular dystrophy.

The FDA has identified as many as 6000 "orphan" diseases that affect 25m people.

Before Congress enacted the Orphan Drug Act of 1983, only 38 drugs existed that were considered orphan drugs. Since the law was passed offering tax credits, marketing exclusivity and other incentives, the FDA has approved more than 200 treatments for rare diseases and disorders.

In June this year, the committee approved a companion measure that would establish an Office of Rare Diseases at the National Institutes of Health (NIH) with annual authorised funding of $ 24m.

The two House bills together mirror a single bill approved last December by the Senate Health, Education, Labor and Pensions Committee.

An aide to Foley said the measures could come to vote on the floor of the US House of Representatives in about two weeks.

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