The debate over whether drug firms should be required to delay the start of DTC advertising will be intense this year, according to The New York Times.
A DTC blackout period will be on the table during hearings on the reauthorization of the Prescription Drug User Fee Act (PDUFA), which sets the user fees manufacturers pay to speed the reviewing of new drugs. The drug industry seeks to renew the law and add a new set of user fees that would pay salaries for additional FDA employees to evaluate all consumer drug ads, before they are shown on television.
Both the industry and its critics agree that there should be a pause before the advertising starts. Industry critics in both the House and Senate believe the moratorium should be mandatory, according to the Times. FDA would be granted the power to require moratoriums under a bill sponsored by Senators Ed Kennedy and Michael Enzi, the chairman and ranking Republican member of the Senate Health, Labor, Education and Pensions Committee.
The industry favors a voluntary delay. Twenty-seven PhRMA members have endorsed voluntary guidelines promising to hold off on consumer advertising of a new medicine for an unspecified “appropriate” period. But firms interpret that differently. Bristol-Myers Squibb waits 12 months, while Johnson & Johnson and Pfizer said they would wait six. According to TNS Media Intelligence, companies have been waiting 15 months, on average, post Vioxx.
Another criticism lodged by lawmakers: the FDA has been slow to crack down on drug ads that included “false and misleading” claims.
Corporate lawyers say drug advertising is protected by the First Amendment. And while the Supreme Court has ruled on related matters in the past, experts say the debate over new pharmaceutical advertising restrictions is unlikely to reach the highest court. “I don’t believe either side really wants to see a definitive case go to the Supreme Court because neither side is willing to take the risk that they will lose,” a law professor and bioethics specialist at the University of Wisconsin in Madison told the Times.