More MS news articles for Aug 2001

Sen. Hatch urges pharmaceutical companies to develop 'orphan drugs'

Sun, Aug 5, 2001 00:00:00
Standard-Examiner Capitol Bureau

WASHINGTON -- Utah Sen. Orrin Hatch has introduced legislation aimed as spurring pharmaceutical companies to conduct more research into so-called orphan drugs -- medicines that can treat or cure rare diseases and disabilities that affect a relatively small number of Americans.

Hatch's new bill would expand the "Orphan Drug Tax Credit" legislation he carried in 1983. The law gives drug companies a tax credit to develop products to treat diseases and disorders affecting fewer than 200,000 Americans, a population typically too small to attract the drugmakers' interest.

Millions of Americans suffer from so-called orphan diseases, which include: amyotrophic lateral sclerosis (ALS) or Lou Gehrig's disease; cerebral palsy; cystic fibrosis; epilepsy; and Huntington disease.

"The Orphan Drug Tax Credit has been very successful," Hatch said. "In the case of multiple sclerosis, six years ago there was no treatment for any type of the disease, only for its symptoms. Thanks in large part to this law, there are now three products on the market to treat the disease."

However, despite the 1983 credit's successes in motivating companies to develop remedies for rare diseases, it is not achieving its full potential because of a design flaw, the Utahn said. Under current law, qualifying expenses for the credit are those paid after the date on which the drug is designated as a potential treatment.

"The problem is that qualified expenses incurred during the time it takes the Food and Drug Administration to consider the official designation of the drug as an orphan are not eligible for the credit," Hatch said.

"Unfortunately, the FDA approval process can take from two months to more than a year. In some cases, companies developing these potentially life-saving drugs are left with a difficult decision delay the start of the clinical trials until the designation is received, or go ahead with trials without the designation but forego the benefits of tax credit that is so crucial to offsetting the high cost of developing these drugs."

Hatch said neither choice is in the best interest of millions Americans who are waiting and hoping for a cure or a treatment for their disorder.

The new bill would solve the delay problem by providing that qualifying expenses include those incurred after the date on which the company files an application with the FDA for designation of the drug as a potential treatment for a rare disease, so long as the FDA actually makes the designation.

Copyright ©2001, Ogden Publishing Corporation