Drug Cos. Work to Stave Off Legislation

WASHINGTON Proposals under consideration for the pharmaceutical industry's voluntary advertising code include a third-party review of the ads, making the review process open to the public and developing an enforcement plan, should companies violate the rules, sources said.The Pharmaceutical Research and Manufacturers of America, the drug industry's trade group known as PhRMA, has been studying the ad codes of the Better Business Bureau's National Advertising Division and the Distilled Spirits Council of the U.S. as it struggles to develop a self-regulating formula it hopes will fend off government legislation. Whatever the industry decides, it will affect scores of ad agencies handling direct-to-consumer and over-the-counter accounts and the media sellers, especially network, cable, syndicated, spot and Hispanic TV, which has seen the category soar in importance in recent years. Big Pharma has been the fifth-largest buyer of television time in the U.S. in the past three years, surpassing $6.5 billion in 2004, up 22 percent from the prior year (which was up 19 percent over 2002's $4.5 billion-plus, per Nielsen Monitor Plus). Agreeing on a code became more urgent after July 1, when Senate Majority Leader Bill Frist said that drug ads increase healthcare costs and companies should put a two-year delay on advertising new drugs. "A lot of direct-to-consumer advertising is misleading," Frist said. "This ... advertising can oversell hope. It could oversell results. And it can also undersell the risk."Congress has also tightened the screws. Rep. James Moran, D-Va., introduced a bill that would prohibit broadcasting erectile dysfunction ads from 6 p.m. to 10 p.m. The bill seeks to prevent exposing children to ads for Cialis, Levitra and Viagra. Other bills propose to remove the tax deduction for the cost of preparing drug ads and require that ads for drugs determined to impose an "unreasonable risk" must include a statement which says so.PhRMA spokesman Ken Johnson confirmed the models under consideration, but declined to discuss content. "They are models we have reviewed, but ... we are developing our own set of principles," he said. W.J. "Billy" Tauzin, PhRMA's president and former House Committee on Energy and Commerce chairman, wants to present a draft code to his board later this month. A committee made up of member companies has been asked to agree on and craft a draft. But sources said the task has been difficult because not all members even want a code. Pfizer, Johnson & Johnson and Bristol-Myers Squibb are pushing for a code, while others, like Schering-Plough and Wyeth, are "less enthusiastic," said one source.The sticking points include: -- Should the code's review board be composed of members outside the industry like the BBB code or come from inside the industry following the DISCUS model?-- Should ad decisions be made public? Some members argue that if a company violates its industry's code, it is more vulnerable to lawsuits claiming the ads did not sufficiently inform patients about risks. Now that the once heavily marketed Celebrex and Vioxx are linked to cardiac problems and have been removed from the market, the threat of lawsuits is more real.-- Should code violators be referred to the Food and Drug Administration? Some think the FDA will take too long to review cases. So far this year, the FDA has sent 16 enforcement letters to companies regarding drug ads.-- Should "reminder" ads-to help people recall a drug-be allowed? Critics say they don't provide consumers with enough detail, while others say they are a crucial to campaigns.-- Should the code cover all ads, including radio, print and the Internet, or just TV spots, as some members prefer?"People are coming to the table wanting to do the right thing," said Dolly Judge, Pfizer's senior director of government relations. Judge declined to discuss specifics. A Schering-Plough rep said the company was "participating in the discussions." Wyeth did not return a call.Some member companies have increased the pressure on PhRMA to develop a comprehensive code by changing their own codes. Bristol-Myers, for example, has imposed a ban on advertising new drugs for one year, a step PhRMA is not expected to take in its new code. "By having this 12-month delay, ... physicians have a comfort level, a knowledge base and a full understanding of our new medicines before we start mass-media advertising to consumers," said Bristol-Myers rep Brian Henry.

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Drug Cos. Work to Stave Off Legislation

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