Magazine article Drug Topics

Congress Debating Overhaul of Orphan Drug Act Again

Magazine article Drug Topics

Congress Debating Overhaul of Orphan Drug Act Again

Article excerpt

For the third time in six years, Congress is trying to revise the Orphan Drug Act, which has spurred development of medicines to treat rare illnesses and also resulted in windfall profits to a few companies. Efforts to find a balance between incentives and excesses failed in 1990, when then-President Bush vetoed a bill, and again in 1992. Now, a Senate committee has cleared a measure billed as a compromise backed by industry and patient advocacy groups.

One of its chief sponsors, Sen. Howard Metzenbaum (D, Ohio), said changes were needed to deal with blockbuster best-sellers developed in part through tax credits and shielded from competition with extra patent protections. Under S. 1981, every orphan drug would be guaranteed four years of market exclusivity instead of the current seven. Those with limited commercial potential could be granted the full seven years based on a determination by the Department of Health & Human Services.

Also set for change is the basis on which the Food & Drug Administration determines orphan status. Currently, if the drug is for a disease afflicting fewer than 200,000 people in the United States, it is designated an orphan drug. Under S. 1981, whose other sponsors are Sens. …

Search by... Author
Show... All Results Primary Sources Peer-reviewed

Oops!

An unknown error has occurred. Please click the button below to reload the page. If the problem persists, please try again in a little while.