US House C'tee approves FDA DTC review role

A US House of Representatives' subcommittee has cleared proposals for the oversight by the Food and Drug Administration of direct-to-consumer advertising by drugmakers. The more rigorous restrictions were removed, amid concerns that any outright ban or delay would be open to a constitutional challenge under the First Amendment (which protects freedom of speech).

Instead, the Democrat-controlled subcommittee voted 23-nine to give the FDA the authority to fine drug firms up to $250,000 for running "false or misleading" advertisement, according to Reuters. The purpose of a ban, Rep Henry Waxman (Democrat, California) explained, would be "dampening consumer interest in a drug whose risks may be serious but are not yet fully known."

The proposals form part of the House's version of the Prescription Drug User Fees Act (Marketletters passim) which, assuming it is carried in a full session of the 435-member assembly sometime in July, must be reconciled with legislation previously approved by the Senate. President George W Bush is then expected to sign the proposals into law.