Sen. Ted Kennedy (D-Mass.) is planning an April 18 mark-up of a bill that would limit prescription drug ads for up to two years after the introduction of a new drug. It would also require pre-submission of ads to the FDA, and increase mandatory disclosures.
Initially the bill would have required ads to be pre-screened rather than just submitted, but according to source Kennedy plans to amend the bill to change that to simply submitting the ads that are being aired.
Kennedy is chairman of the Health, Education, Labor and Pensions Committee, where the bill will be marked up. That process is essentially a committee review of the bill during which amendments are added, withdrawn and debated.
Dan Jaffe, the Association of National Advertisers executive VP of government relations, says his group is putting out an alert to members, calling the Enhancing Drug Safety and Innovation Act of 2007 "one of the most significant pieces of legislation to come before Congress in some time." He said the new Kennedy amendment was an improvement, but said the other two provisions appeared still to be in the bill, though he called it a "moving target."
Drug manufacturers adopted a voluntary
that includes many of the same steps being proposed in the bill, but Kennedy wants to make it mandatory.
The bill deals with a range of drug safety measures, including labeling and application procedures, but ANA is concerned about the ad restrictions. Jaffe says the bill is likely to move, so his group is focusing on getting the Senators to drop or modify the ad restrictions, which he calls a dangerous precedent and a threat to advertisers First Amendment rights and the public right to know about new products. "The ability to reach the public with health information is a very critical need for society," he told B&C.