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.
Senator Roberts’ amendment would have struck the two-year moratorium and mandated warning requirements and instead substituted a requirement that all television advertising be submitted to FDA for review 45 days in advance of broadcast and provided for civil monetary penalties for ads that are false or misleading. As Senator Roberts stated at the markup, his amendment tries to “strike a balance” between those who favor broad regulation in this area and those who seek to protect First Amendment rights.
Senator Roberts, joined by Senator Coburn, further noted that the two-year moratorium was predicated on what the FDA does not know, rather than what it does, since the speech moratorium would take effect before the prescription drug is even on the market. It also puts the FDA in the role of an editorial board overseeing drug ads. Senator Coburn also noted the FDA has sufficient authority to review ads right now. Finally, and most significantly for advertisers as a whole, Senator Roberts noted that these restrictions could be used as precedent for restrictions or bans in categories as wide ranging as automobiles and food ads.
It is worth noting that a number of Senators who had been supporting Senator Kennedy’s initial legislation, including the ranking Republican member of the HELP Committee, Senator Mike Enzi (D-WY), voted against the restrictive provisions in S. 1082. While the committee voted down the amendment, Senator Roberts offered to continue to work with the members of the committee to reach a compromise agreement on the advertising provisions in the bill. We, in turn, will continue to work with members of the Senate in the hope that these provisions can be removed on the floor.
It is critical for the entire advertising industry to oppose these proposals as they create very dangerous precedents for the ad community at large. If these types of sweeping ad bans can be imposed in the prescription drug arena, which already is one of the most regulated areas of advertising, then all other advertising categories are seriously jeopardized.
The Waxman house version is likely to be a three year moratorium and will likely pass.
‘‘(VI) A temporary moratorium on direct5
to-consumer advertising, if required under sub6
section (o)(4)(H) for the applicable listed drug.
http://www.henrywaxman.house.gov/pdfs/bill_drugsafety_110th_3-22-2007.pdf
Posted by: Palisades Park | May 11, 2007 at 09:31 AM