Legislation proposed in the Senate Health Education Labor and Pensions Committee could allow the Food and Drug Administration to ban DTC ads for the first two years of a new drug. It would also require ads for new drugs to carry additional warnings and a statement that the drug has just recently been approved and all risks may not be known.
Fearful of broad bans
Ad groups are fearful that the FDA, instead of using the authority selectively, would broadly ban ads for all new drugs. They have been arguing that an ad ban would hurt consumers and also violate the First Amendment.
"It is the most serious threat to advertising that I've seen in a decade," said Jim Davidson, a lobbyist for advertising groups. "The principle here is what powers should be given to a federal agency to scrutinize and block commercial speech."
The DTC curb is tucked into legislation reauthorizing user-fee charges for the FDA's review of new drugs that Congress needs to pass in some form this year to avoid the current fees from expiring. Versions of the legislation have been offered in both the House and Senate.
Officials of the embattled groups said this week they were holding a number of legislative meetings in advance of the committee vote of various amendments to the legislation and would be sending letters to Capitol Hill. They also said they have been getting local media companies and ad agency execs to call legislators.
The DTC curb is tucked into legislation reauthorizing user-fee charges for the Federal Drug Administration's review of new drugs. Congress must pass the legislation in some form this year as current fees are set to expire. Versions of the legislation have been offered in both the House and Senate.
Change made to bill
A change to the Senate bill made this week should please advertising groups -- drug ads would have to be presubmitted to the FDA, but no longer have to be preapproved. In other words, ads can be run as long as they've been submitted to the FDA for review. A previous version stipulated that the FDA must approve ads before they hit the air.
Still, opponents of the bill are far from happy.
"We believe those proposals are just misguided and go way beyond what is appropriate," said Dan Jaffe, exec VP of the Association of National Advertisers. "It would block companies from giving information about what might be lifesaving or protective drugs."
Dick O'Brien, exec VP of the American Association of Advertising Agencies, said the various ad groups are trying to educate lawmakers on the different roles DTC plays in society.
"We want to make sure that members of Congress are aware of the full value of DTC," he said.