updated 8/2/2005 4:40:13 PM ET 2005-08-02T20:40:13

The pharmaceutical industry unveiled new guidelines Tuesday for the marketing of medicines to patients, including pledges to educate doctors before beginning consumer campaigns and more clearly outline the risks involved in taking prescription drugs.

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“With these principles, we commit ourselves to improving the inherent educational value of advertisements,” Billy Tauzin, president and CEO of the Pharmaceutical Research and Manufacturers of America, said in a statement. Details of the plan were being announced at a conference in Dallas.

But critics responded that the voluntary code is toothless, and many of its 15 principles — such as presenting information that is accurate and not misleading — are already required by law. The guidelines also lack elements some critics have sought, including a mandatory waiting period for advertising new drugs and restricting when sensitive medicines such as erectile dysfunction drugs could be advertised.

“This is just an attempt to fool people into thinking something that really isn’t true,” said Dr. Sidney Wolfe, the director of Public Citizen’s Health Research Group. “They are designed as a desperate attempt to fend off real regulation of drug ads.”

Pharmaceutical ads have been under an intense spotlight since Merck & Co.’s removed its pain reliever Vioxx from the market last year after a study found it doubled patients risk of heart attacks and strokes. Vioxx was heavily marketed, and doctors say the ads may have pushed many patients who really didn’t require the pricey drug to take it, potentially exposing them to dangerous side effects.

Advertising has become increasingly commonplace since regulators relaxed rules on TV commercials in 1997. Last year, the industry spent $4.02 billion on advertising, up 23 percent from 2003 and 62 percent from 2000, according to the consulting firm IMS Health.

But now there is backlash. Last month, U.S. Senate Majority Leader Bill Frist of Tennessee called for a two-year moratorium on advertising new drugs, saying commercials drive up health care costs. Thirty-five percent of American adults favor a mandatory ban on consumer ads for new drugs for a limited time, according to a survey conducted by Harris Interactive for the Wall Street Journal Online’s Health Industry Edition.

Only 18 percent of consumers believe pharmaceutical ads can be trusted “most of the time,” according to a study released Friday by the Kaiser Family Foundation. That’s down by almost half since 1997, when one-third of people surveyed said you could trust ads most of the time.

Meanwhile, a study by Iposos-Insight Corp. found that consumer response to pharmaceutical advertising has been steadily declining since 2002. Last August, 19 percent of those surveyed said an ad prompted them to call or visit a doctor. That’s down from 25 percent in February 2002.

The new guidelines being released in Dallas are designed to restore faith in drug ads as well as the industry overall image which has been battered by product recalls, allegations of hiding clinical trial results and high prices.

Among the guidelines:

  • To foster communication between patients and health care professionals, companies should spend an “appropriate time to educate health professionals” about new treatments before beginning direct-to-consumer campaigns.
  • Ads should be targeted to avoid audiences that are not age-appropriate for the commercial.
  • Ads should be designed to achieve balanced presentation of both the benefits and the risks associated with the medicine.
  • Ads that mention a product by name should clearly state the health conditions for which the medicine is approved and that risk associated with the drug. Currently, if a company doesn’t say what the drug does, it doesn’t have to include the risks.

Separately, the Wall Street Journal reported Tuesday that the Food and Drug Administration could announce soon that it would examine its drug advertising policies, which could lead to tougher regulations.

© 2013 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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