WASHINGTON — While calls for the drug industry to clean up its multibillion-dollar advertising act grow louder, companies are quietly pushing for more lenient rules for pitching drugs directly to doctors.
Ten of the largest drugmakers urged the Food and Drug Administration on April 18 to quickly approve guidelines for how pharmaceutical companies can use medical-journal articles to promote drugs for unapproved uses.
The effort comes as politicians on Capitol Hill and on the presidential campaign trail call for restrictions on drugmakers' more high-profile efforts in commercials and print advertisements.
Companies are not allowed to promote products for "off-label" uses, or those that have not been cleared by the FDA as safe and effective. However, the FDA has allowed companies, usually salespeople, to distribute medical journal articles about such uses.
Comments submitted to FDA by Pfizer Inc., Amgen Inc., Eli Lilly & Co. and others support the FDA's proposal to reauthorize the practice, saying it helps doctors stay current on medical innovations.
"These articles are already available in every library in the country," said Alan Bennett, a lawyer advising the drug companies. "I don't think that because a 'New England Journal of Medicine' article is handed out by a pharmaceutical company that changes the science of the article."
But Democratic lawmakers, including Rep. Henry Waxman of California, have said the rules would give companies too much leeway in publicizing unapproved uses of their products. They want the FDA to review the indications discussed in articles before companies distribute them to doctors, as was required under now-expired regulations.
FDA will continue taking comments on the issue through today and is expected to issue a final regulation in coming months.
While drugmakers may be on the cusp of winning more freedom to promote medicines to doctors, their consumer-directed marketing campaigns are getting increasingly negative attention from politicians. Congressional lawmakers on both sides of the aisle are investigating whether advertisements for blockbuster drugs from Pfizer Inc., Merck & Co. Inc. and Schering Plough Corp. have misled consumers.
Company executives gathered in Washington on April 18 for an annual meeting on pharmaceutical marketing, which appears to be leveling off after years of expansion. Spending on consumer-directed drug advertising fell 3% last year to $5.4 billion, according to Nielsen Media Research. It was the first drop in the industry's history. Marketing budgets are shrinking as many of the blockbuster drugs of the 1990s lose patent protection and begin competing with low-cost generics.
Adding to industry's difficulties are charges by some in Congress that expensive drug marketing campaigns have driven up the cost and encouraged overuse of drugs.
"When you put cost and patient safety together, those are two powerful forces that will have people saying 'what more can we do to regulate this arena?'" said James Davidson, director of the Advertising Coalition, which lobbies for media and drug companies in Washington.
Davidson's group is working against efforts in Congress to curb drug advertising, including a proposal from Rep. Rosa DeLauro, D-Conn., that would ban consumer marketing for the first three years a drug is on the market.
"Advertising is a First Amendment-protected form of free speech," Davidson said. "My clients are very concerned when legislators begin talking about proposals to restrict that speech."
Meanwhile, Rep. John Dingell, D-Mich., and Republican Sen. Charles Grassley, R-Iowa, are probing whether Merck and Schering-Plough oversold the benefits of their drug Vytorin, the cholesterol pill that has battered the stocks and reputations of both companies. Merck and Schering pulled their advertisements for the drug in January, immediately after releasing data that showed their drug was no more effective at stopping some types of plaque buildup than a low-cost generic. But lawmakers have seized on the fact that the companies had those results as early as 2006 yet continued to run advertisements.
Earlier this year Pfizer announced it would discontinue its signature ads for Lipitor, the best-selling drug in the world, after Dingell raised questions about spokesman Dr. Robert Jarvik's credentials.
The Energy and Commerce Committee chairman said that Jarvik, the artificial heart inventor, was unqualified to give medical device since he is not a licensed physician. Though he did earn a medical degree, Jarvik has acknowledged that he never completed the certification tests needed to practice medicine.