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Drug industry unveils guidelines on direct-to-consumer ads

WASHINGTON—The drug industry's main lobbying and trade group on Tuesday proposed modest, voluntary new controls on ads that its companies aim at consumers.

The move came as the Food and Drug Administration prepared to open hearings on drug ads and congressional investigators began to look into the FDA's oversight of drug company advertising.

The 15 new "guiding principles," offered by the Pharmaceutical Research Manufacturers of America, are unlikely to ward off these probes or lawmakers critical of drug advertising.

Among those lawmakers is Senate Majority Leader Bill Frist, R-Tenn., who last month called for a two-year moratorium on advertising new drugs directly to consumers. On Tuesday, Frist said in a prepared statement that he wished PhRMA had gone further and adopted a moratorium. Earlier, he'd asked the Government Accountability Office, Congress' watchdog, to review the FDA's drug ad oversight.

Drug advertising aimed at consumers is a fast-growing field that produced more than $4 billion in bookings last year, according to TNS Media Intelligence, which tracks marketing campaigns. In 1999 the drug ad outlay for direct-to-consumer ads was $1.6 billion.

The industry's new voluntary ad guidelines ask companies to produce only commercials whose claims are supported by "substantial evidence." Companies also agree to submit ads to the FDA before they're aired. Commercials should balance the benefits and drawbacks associated with a drug, the guidelines state. PhRMA is also setting up an Office of Accountability to field comments about drug ads from patients and doctors.

"We are saying that we will place a balanced emphasis on the risks as well as the benefits of medicines," said William Weldon, chairman of PhRMA's board of directors, at a news conference in Dallas. At the meeting, PhRMA and drug company executives lauded the role of advertising and said they adopted the guidelines to address consumers' concerns about possibly misleading commercials.

PhRMA President and CEO Billy Tauzin, a former U.S. representative from Louisiana, said that his group was adopting a "whole host of changes," among them asking companies to air commercials with mature content only during adult-viewing hours.

One critic of the drug industry expressed skepticism about the voluntary controls.

"There's very little in these `guiding principles' that will change the role of direct-to-consumer advertising," said John Abramson, a clinical instructor at Harvard Medical School and author of 2004's "Overdosed America."

Bristol-Myers Squibb Co., a PhRMA member, is going beyond the guidelines. It announced in June that it would refrain from promoting its new drugs directly to consumers for at least a year.

Several of the new guidelines are recastings of existing FDA regulations, said Michael Montagne, a pharmacy professor at the Massachusetts College of Pharmacy and Health Sciences in Boston. For instance, the FDA already asks companies to submit ads when they're aired or published.

Montagne said the industry's guidelines were part of the drug companies' campaign to improve their image and get lawmakers and groups such as the American Medical Association off their backs.

Their voluntary guideline strategy, he said, "isn't going to quiet the criticism of direct-to-consumer advertising."

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(c) 2005, Knight Ridder/Tribune Information Services.

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