The war of words over direct-to-consumer drug advertising has opened a new front on Capitol Hill. At the center of this debate are two opposing armies of lobbyists, and they're vowing a showdown over new legislation that would put a major crimp in the advertising plans of some of the countries biggest pharma companies. The guns of Washington are focused on Senate Bill 3807, co-sponsored by Wyoming Republican Mike Enzi and Massachusetts Democrat Ted Kennedy. Together, they are seeking a new law that would mandate drug developers to post clinical trial data, complete post-approval safety studies and clarify rules for selecting advisory committees at the FDA. But advertising advocates are particularly concerned by provisions they say would require the FDA commissioner to approve drug ads in advance or bar them for up to two years after the drug is approved. "These provisions would give the government the ability to require preclearance as a condition for approving a medicine. We believe they would constitute an unconstitutional restraint on the exercise of free speech," said the American Advertising Federation (AAF) in a statement. "It's been something tossed around for quite some time," said Clark Rector, senior vice president of governmental affairs for the AAF, "but at the same time there's quite a bit of opposition to it." There have been cases where the FDA and drug makers mutually agree to hold back ads on a new drug. But when lawmakers want to give the FDA commissioner blanket authority to do it whenever he likes, the AAF and others are going to raise a ruckus. With well over $4 billion in annual advertising spends on the line, this is one issue that raises passions. In the view of the industry trade group Pharmaceutical Research and Manufacturers Association (PhRMA), ads directed straight to consumers offer a chance to educate them on the proper use of the drugs. Under voluntary guidelines, its members are urged to devote an "appropriate" amount of time to educating professionals about a new drug before blitzing consumers with their campaigns. "The length of time this requires will vary from medicine to medicine, and companies will likely meet this goal in different ways," said AAF president and CEO Wally Snyder. "Importantly, FDA officials and others have indicated in public statements that advertisements airing since the principles took effect in January have tended to be more educational and informative. "If a drug is not ready, by all means keep it off the market. But once approved, once the stringent requirements of clinical trials and other testing are done, and the drug approved, please do not send a mixed message by banning advertising. Regulate the drug, but do not impede the flow of truthful information." Bill Vaughn, senior policy analyst for the Consumers Union in congressional testimony, countered: "People who make money off of advertising and mass marketing drugs that may not be fully safe may have a different point of view than we do." But the history of drug safety over the last few years, he added, points to moderation. "Left voluntary, somebody will always be pushing at the edge and trying to get ahead of their competitor," he said. Even some of PhRMA's traditional allies have voiced their concern about the issue. "Research evidence indicates this blitz in direct marketing has unwittingly led to inappropriate prescribing, which most importantly can compromise patient safety and care," Senate Majority Leader Bill Frist said a year ago, as he called for a voluntary two-year moratorium on new drug ads. And the American Medical Association (AMA) has also been calling on Congress to push an ad moratorium. Reform advocates got a big boost in September when a long-awaited report from the Institute of Medicine made plain that the FDA was in need of top-to-bottom restructuring, calling for an ad moratorium on new drugs to help improve the country's safety profile. "Because the emphasis at the FDA is getting drugs quickly to market, the agency often doesn't fully know the safety implications of some of these drugs," Vaughan said. "The FDA shouldn't allow advertising of these new drugs to millions of consumers until it has a clearer understanding of the risks." November 2006