WASHINGTONA federal appeals court has granted expeditious
status to an appeal seeking to overturn a US District Court decision
that found parts of the Food and Drug Administration Modernization
Act (FDAMA) unconstitutional. The district court ruling restricted
the FDAs powers to regulate the distribution by pharmaceutical
companies to physicians of materials regarding off-label uses of
drugs. [See Oncology News International, Oct. 1999, page 1.]
The US Court of Appeals for the District of Columbia will hear oral
arguments in the case on Jan. 4, 2000.
We said all along that we were disappointed by the ruling and
wanted to keep our options open, and we have decided to appeal,
said FDA spokesman Brad Stone.
Last July, Judge Royce C. Lamberth, of the US District Court for the
District of Columbia, ruled that the FDAMA provisions were a
violation of free speech. He barred the FDA from enforcing certain
restrictions that prohibited drug companies from providing physicians
published, peer-reviewed scientific papers and book sections that
discuss the off-label uses of drugs.
Judge Lamberths July ruling followed a similar one by the
jurist in 1998 that overturned then-existing FDA rules. The agency
then argued that provisions in FDAMA superseded those ruled
unconstitutional by the district court, an argument the jurist did
The First Amendment is premised upon the idea that the people
do not need the governments permission to engage in truthful,
nonmisleading speech about lawful activity, Judge Lamberth
wrote in his latest decision.