The chairman of the House Committee on Oversight and
Government Reform provoked industry exponents last month by leaking FDA draft
guidance on off-label journal reprints. But while his move—on the eve of an
election year, no less—riled some, it's unlikely to forestall the guidance or
prompt major changes, sources said.
Rep. Henry Waxman (D-CA) had set a Dec. 21 deadline for the
FDA to respond to his concerns, asking it to delay issuance until then. At
press time, an FDA spokesperson told MM&M the agency “will be responding to
the congressman directly.”
The situation is likely to lead to some enforceable rules,
said John Kamp, executive director, Coalition for Healthcare Communication.
“With the passing of the [FDA Modernization Act] rules, which enabled some
off-label distribution of peer-reviewed articles, it's really incumbent on the
FDA to bring some clarity to this situation,” Kamp said.
That's not to say Rep. Waxman's criticisms won't be taken
into account. The draft criteria would allow drug reps to hand out “truthful
and non-misleading” journal reprints and other publications on unapproved uses
of approved drugs and devices to healthcare professionals, as long as they are
published by a peer-reviewed organization. The congressman is worried about the
enforceability of the criteria and that manufacturers will use the guidance as
a pretext to promote off-label.
Rep. Waxman's position on the House Committee on Energy and
Commerce, which holds sway over FDA, makes him a force to be reckoned with. But
the FDA is enjoined from attempting to suppress reprints, said Richard Samp,
chief counsel, Washington Legal Foundation, which won a permanent injunction to
that effect in 1998.
“Any effort by FDA to adopt a more stringent
rule would place it in contempt of court,” Samp said. “Rep. Waxman is entitled
to ask the government to take actions in contempt of court; but I don't think
that's a particularly responsible suggestion on his part.”