March 1, 1999
Filed at 6:38 p.m. EST
By The Associated Press
WASHINGTON (AP) -- A company's unusual lobbying campaign to win government approval for a new multiple sclerosis drug stalled Monday as the Food and Drug Administration rejected the immediate sale of Rebif.
Serono Laboratories had urged MS patients, doctors and members of Congress to plead with the FDA to approve Rebif. It even advertised in medical journals and Internet sites that Rebif was the best treatment, triggering an FDA investigation of Serono for illegally promoting an experimental drug.
The problem: Rebif's active ingredient is the exact same chemical already sold under another brand name, Avonex. The chemical is an immune system protein called interferon beta-1a.
Drugs containing the same chemical usually aren't an issue -- lots of identical drugs sell in competition with each other.
But Avonex was approved under a special law called the Orphan Drug Act, which provides a big financial incentive for companies to develop drugs for rare diseases like MS: seven years of marketing protection against similar competitors.
Avonex's special marketing protection doesn't expire until 2003. Under
the law, Serono could only sell Rebif before then if it proves that Rebif
is a better drug for at least some MS patients. But the FDA decided Monday
that Serono has not yet proved that extra benefit, meaning that for now
it cannot sell Rebif.
Copyright 1999 The New York Times Company