• by adam.m , Michael Deibert , July 25, 2005

The Pharmaceutical Research and Manufacturers of America's (PhRMA) Board of Directors gave initial approval last week to a set of "Guiding Principals" designed to address the concerns of public advocacy groups and legislators regarding direct-to-consumer advertising of prescription medicines.

Among the key points of the new proposed measures--which drug companies would be responsible for implementing themselves--are targeting of television advertisements for prescription drugs with age and audience appropriateness in mind, a promotion of health and disease awareness as a key part of advertising, and an encouragement of the use of assistance programs among low-income and uninsured consumers.

"We recognize our responsibility to make sure that direct-to-consumer advertisements live up to their potential," said William C. Weldon, chairman and CEO of Johnson & Johnson and PhRMA board chairman, in a press release. "We want to make patients more aware of the benefits and risks of medicines and of the importance of talking to their health care providers--not only about medicines, but also about other treatment options that might help them."

Critics, however, said that the new proposals would do little to inform consumers about the effectiveness or possible safety risks of drugs, suggesting that worries for advertisers about the content of drug ads were far from over.

"The fundamental problem with voluntary guidelines is they are basically what we have in place now," said Rob Schneider, director of the prescription reform project for the advocacy group Consumers Union, which issued a statement criticizing the announcement. "You rely on drug companies to comply with a standard that's very much like the standard that is in current law."

Groups like Consumers Union have been vocal advocates of moves to further regulate advertising for the drug industry such as those proposed by U.S. Senate Majority Leader Bill Frist.

Earlier this month, Frist had called on pharmaceutical companies to observe a two-year moratorium on direct-to-consumer advertising during a drug's first two years on the market. Frist also called on the Government Accountability Office (GAO) to review the Food and Drug Administration's (FDA) oversight of prescription drug activities, and the pharmaceutical industry's spending on advertising.

Frist is by no mean alone in the Senate, as the Food and Drug Administration Safety Act of 2005, co-sponsored by Iowa Republican Senator Charles Grassley and Connecticut Democrat Senator Christopher Dodd, proposed this year, mandates that advertisements for drugs that have been on the market for less than two years and drugs with a known safety risk be reviewed by the FDA before they air to the public.