Monday, March 6, 2000
WASHINGTON - A recent appeals court ruling has lawyers scratching
their heads over FDA's legal authority to limit the ability of drug sponsors
to disseminate peer-reviewed literature about unapproved uses of approved products,
as well as their sponsorship of Continuing Medical Education (CME) programs
for doctors that focus on off-label uses.
Last month's ruling by the U.S. Court of Appeals for the District
of Columbia Circuit "is clear as mud," according to Alan Bennett, an attorney
at Bennett, Turner & Coleman in Washington, and a former attorney at FDA.
Indeed, both the Washington Legal Foundation (WLF), which had sued to restrict
the agency's off-label powers, and government officials are claiming victory.