.c 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.