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n engl j med 356;22 www.nejm.org may 31 , 2007 2236 Drug Risks and Free Speech — Can Congress Ban Consumer Drug Ads? Miriam Shuchman, M.D. I n 2004, the discovery that Vioxx (rofecoxib) was a risky drug put direct-to-consumer pharmaceutical advertising in the spotlight. The image of Dor- othy Hamill lacing up her skates and gliding over the ice despite her osteoarthritis offered a dis- turbing contrast to the public re- alization that millions of pa- tients who were lured by the ad into taking Vioxx were risking stroke or myocardial infarction. Now, 3 years later, legislation that — if it is not amended, as some legislators want — would allow the Food and Drug Ad- ministration (FDA) to block di- rect-to-consumer ad campaigns for new drugs has been intro- duced in Congress (see graph). There is popular support for a ban: in a telephone survey con- ducted in March 2007 by Consum- er Reports, 59% of respondents “strongly agreed” that the FDA should ban advertisements for drugs that had safety problems. But some legal scholars believe that such a ban would be over- turned by the courts as unconsti- tutional. If Congress wants to turn its proposals into law, said Robert Post of Yale Law School, it needs to find a different way of approaching the issue. The authority to ban direct-to- consumer advertising is included in two drug-safety bills that have Copyright © 2007 Massachusetts Medical Society. All rights reserved. Downloaded from www.nejm.org at UNIVERSITY OF GEORGIA on May 31, 2007 .
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n engl j med 356;22 www.nejm.org may 31 , 2007 PERSPECTIVE 2237 been wending their way through the legislative process — one sponsored by Senators Edward Kennedy (D-MA) and Michael Enzi (R-WY) and the other by Repre- sentatives Henry Waxman (D-CA) and Edward Markey (D-MA) — that build on last year’s recom- mendation from the Institute of Medicine (IOM) that a special sym- bol be placed on the packaging of new drugs for their first 2 years on the market and that advertis- ing to consumers be prohibited during that period. 1 Though the two bills aim to prevent large numbers of people from being exposed to new drugs with “not- acceptable to the courts. The Ken- nedy–Enzi bill has been the sub- ject of heated debate on the Sen- ate floor, and Kennedy said that he had been working with Sena- tors Tom Harkin (D-IA) and Pat Roberts (R-KS) “to refine our pro- visions on direct-to-consumer ad- vertising, to make certain they are consistent with the Constitution.” The courts view advertising as a form of “commercial speech” and have ruled in a series of cas- es dating back to the 1970s that banning advertising violates First Amendment protections of free- dom of speech. In the 1975 case Bigelow v. Virginia, the Supreme Court ruled that since abortion was legal in New York, the state of Virginia, which still prohibited abortion, couldn’t stop newspa- pers from advertising the proce- dure. The next year, the Court ruled in Virginia State Board of Pharmacy v. Virginia Citizens Con- sumer Council that the state could not stop pharmacists from post-
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