Senate HELP Committee Votes to Keep Restrictive Ad Proposals in Drug Safety Bill

Yesterday, the Senate Health, Education, Labor and Pensions (HELP) Committee held a markup on S. 1082, the Food and Drug Administration Revitalization Act. 

The bill as written contains provisions that authorize the FDA to impose a two-year moratorium on advertising for prescription drug products and allows for additional government-mandated warnings in ads.  The FDA could impose these restrictions even if there is no known adverse event associated with the drug and even though the drug ad contains a fair balance between the benefits and risks. 

In response, Senator Pat Roberts (R-KS), joined by Senator Richard Burr (R-NC) and Senator Tom Coburn (R-OK), introduced an amendment that removed some of the more restrictive advertising proposals.  The Roberts amendment requires all television advertising to be submitted to FDA for review 45 days in advance of broadcast and provides for civil monetary penalties for ads that are false or misleading.

Unfortunately, the amendment was defeated on an 11-10, party line vote. 

ANA is calling on the entire advertising community to oppose the Kennedy approach as it creates very dangerous precedents for many other advertising categories.  As Senator Roberts noted at the markup, he could just as easily see these limits being applied to automobile and food ads.  If broad additional restrictions can be imposed on prescription drug advertising, which is one, if not the most, regulated categories of advertising in this country, then other less regulated advertising areas are seriously jeopardized. 

We hope to convince other Senators that these provisions are counterproductive and should be removed when the bill reaches the Senate floor. We will alert ANA members before the bill reaches the Senate floor in order to launch a strong advertiser community response in opposition to these misguided proposals. 

If you have any questions, you can reach Dan Jaffe in ANA 's Washington office at 202-296-2359 or at