Pharmacy group issues principles for direct-to-consumer ads

Recently, criticism of direct-to-consumer prescription drug advertising appears to be reaching higher pitch levels. In response, the Pharmaceutical Research and Manufacturers of America has released guiding principles on the subject.

Companies that sign on to these principles will agree to submit broadcast ads to the Food and Drug Administration before the ads are aired. Additionally, pharmaceutical companies agree that ads will be shown at times when the most appropriate target market is watching.

Ads should clearly state benefits and risks of the product in plain language and, when appropriate, educate about lifestyle changes that might be helpful. Additionally, physicians and other health care professionals should be educated first before any DTC ad campaigns are launched.

"By formally adopting these guidelines, we are committing to the American people and the medical community that we will use advertising not only to promote new medicines but also to educate consumers about health and disease," said William C. Weldon, chair and CEO of Johnson & Johnson and PhRMA's board chair. "We are saying that we will place a balanced emphasis on the risks as well as the benefits of medicines."

PhRMA also will establish an "office of accountability" that will take feedback on the ads and issue periodic reports on how member companies are sticking to the code.

This action comes in the wake of increasing scrutiny from health care professionals and the federal government. The American Medical Association is currently studying recommendations to make DTC advertising less troublesome for physicians.

Also, in May, a bill was introduced in the Senate calling for increased rebates to government programs for any drugs advertised to consumers. The rebates would be paid by the drug's manufacturer.

Those skeptical about DTC advertising said PhRMA's code was a step in the right direction. There were, however, some reservations about its voluntary nature and its reach -- mostly because not every pharmaceutical company is a PhRMA member.

Meanwhile, though, the code will take effect in January 2006, and experts are interested to see how these principles will be used in actual practice.

"It's a good first step," said AMA Trustee Edward L. Langston, MD, RPh. "But how do you enforce them? We will wait and see."