Madison Avenue Money Trumps Drug Safety; House Dems Gut DTC Language In PDUFA
1 CommentBy Ed Silverman // June 19th, 2007 // 11:29 pm
In the end, it was about money and constituents.
Members of a House panel rebelled against their chairman late Tuesday, stripping tough restrictions on direct-to-consumer advertising from a draft FDA overhaul measure, Congressional Quarterly is reporting. The restrictions, which would have given the FDA discretion to ban DTC for a new drug for up to three years, were gutted from the bill by the House Energy and Commerce Health Subcommittee.
A trio of New Yorkers - Edolphus Towns, who offered the amendment, Anthony Weiner and Eliot Engel - led a Democratic split with subcommittee chairman Frank Pallone of New Jersey and California’s Henry Waxman, who wrote much of the ad provision. The New Yorkers, joined by six other Democrats, voted with Republicans to adopt a less restrictive amendment relying on fines and voluntary ad review by the FDA. The vote was 23-9.
Much of the rhetoric centered on First Amendment concerns, but the New Yorkers also had other concerns. “These things are very important for the New York economy, quite frankly,†Engel says of the television and print ads that Pallone’s substitute amendment targeted. “The networks are all located in New York, the advertisers are all located in New York. It’s a big hometown industry.”
Pallone declined to comment on why he thought the rebellion succeeded but said he might come back with a revised ad proposal. “I would like the issue to be addressed,†he says. “I think now we do have essentially a voluntary system, and that doesn’t prevent bad actors.â€
Towns’ amendment was added to a substitute to one of nine draft measures approved by the subcommittee Tuesday, all dealing with FDA drug and medical device policy. Under the amendment, the government would have no authority to require changes to the ads. For “false or misleading ads,†there would be a maximum penalty of $250,000 for the first offense and $500,000 for subsequent offenses.
The panel rejected, 13-17, an amendment by ranking Republican Nathan Deal of Georgia that would have reduced penalties on drug makers for not complying with other parts of the risk-reduction draft bill, including requirements to complete safety studies on drugs after FDA approval.
Under the bill, drugmakers could be fined $20 million for a single violation, and up to $100 million in total.
The subcommittee approved eight other draft bills, and all nine are expected to be considered by the full Energy and Commerce Committee on Thursday. Pallone says the drafts might eventually be packaged as a single bill, similar to the FDA overhaul bill (S 1082) passed earlier this year by the Senate. The measures are expected to be taken up on the House floor in July.
Republicans tried twice to attach amendments to the substitute measure reauthorizing PDUFA. The amendments would have required Congress to appropriate funds for new FDA safety programs authorized elsewhere in the bill, rather than relying on user fees to pay for them. Both failed, and the panel then adopted Pallone’s substitute by voice vote.
The subcommittee approved a similar program for medical devices, adopting Pallone’s substitute amendment.
GOP attempts to loosen language in a conflicts-of-interest draft bill failed, in a voice vote defeat of an amendment by Mike Burger, a Texas Republican. As approved by the committee, the bill would allow FDA advisory panels on drugs and devices only one waiver for experts with financial conflicts of interest relating to the product under review. Republicans and the FDA have argued that the agency needs more freedom to bring in experts, who often conduct research for the companies whose products are being considered, and that disclosure of the conflicts goes far enough.
The subcommittee also adopted and approved a substitute amendment to a clinical trials registry draft bill. The measure would create a registry of ongoing clinical trials by drug and device makers, and an additional online database of trial results.
Also approved, by voice vote, was a draft bill on pediatric medical devices. The bill would give priority to drug company applications for pediatric uses and would create FDA authority to require pediatric safety studies.
Another draft pediatrics bill approved by the panel would extend a law (PL 107-109) that gives drug makers six months of sales exclusivity for new pediatric uses of drugs.
An amendment by Anna Eshoo, a Democrat from California, adopted 21-10 over Pallone’s opposition, eliminated a provision that would limit exclusivity to three months for “blockbuster†drugs with already high sales.
Lisa Van Syckel
Does anyone know the Status of FDA Pre-emption that was dropped last week from PDUFA?