May 2007 - Senate Approves New Drug Advertising Requirements

Provisions that impact direct-to-consumer (DTC) prescription drug advertising were included in a larger Food and Drug Administration (FDA) reauthorization and drug safety package approved by the Senate in May. An earlier version of the bill would have created a two-year moratorium on advertising for certain new prescription drugs and required certain warnings in advertisements. An amendment, offered by Sen. Pat Roberts (R-KS), deleted the moratorium provision, but the bill still retains an optional Risk Evaluation and Mitigations Strategy (REMS) provision that would allow the FDA Commissioner to require pre-review of DTC advertising for specific new drugs. The Roberts amendment also created a new provision giving the FDA the authority to seek monetary penalties for advertising that is found to be false or misleading. NAA worked aggressively with other members of The Advertising Coalition in support of the Roberts compromise amendment.

A drug safety bill in the House (H.R. 1561), introduced by Reps. Henry Waxman (D-CA) and Edward Markey (D-MA), contains language allowing the FDA commissioner to require specific options for REMS plans, including a three-year moratorium on advertising, FDA pre-clearance of advertisements, and the inclusion of mandated ad warnings. It is anticipated that the House Energy and Commerce Committee will markup FDA reauthorization legislation in June.

First Published:
July 25, 2007