Drug Advertising Amendment Defeated: Next Steps

The Senate Health, Education, Labor and Pensions (HELP) Committee recently voted down an amendment to the drug safety bill (S. 1082) that would have amended provisions in the bill relating to direct-to-consumer prescription drug advertising.  The amendment, which was sponsored by Senators Pat Roberts (R-KS), Richard Burr (R-NC), and Tom Coburn (R-OK), was defeated on an 11-10, straight party line vote. 

The ANA opposed two key provisions of S.1082.  The first authorizes the FDA to impose a two-year moratorium on advertising for new prescription drugs.  The second requires certain government-mandated warnings in new prescription drug ads, even if there are no known adverse events associated with the drug and even if the drug ad contains a fair balance between the benefits and risk. 

We believe these proposals are clearly unconstitutional.  In a letter to the members of the HELP Committee, we argued that the provisions violate the U.S. Supreme Court’s Central Hudson test, which requires that restrictions on advertising must be “no more extensive than necessary” to promote the government’s interest.  A two-year blanket ban on speech almost certainly violates this requirement. 

We also argued that the provisions completely overlook the tremendous value that prescription drugs ads provide the public.  Ads often encourage patients to discuss health issues with their physician. Studies by the FDA and Prevention magazine demonstrate that as many as 65 million Americans went to a doctor in response to a prescription drug ad, and of this number, over 30 million asked the doctor about a health condition that they had never discussed with a physician before.  On many occasions, the physician identified serious, previously undiagnosed conditions, including high blood pressure, high cholesterol, or diabetes during the visit.