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