By Lisa Seachrist

Washington Editor

WASHINGTON—The FDA has opened the door to what could be a flood of direct-to-consumer television and radio advertisements for drugs and biologics.

In a draft guidance, the agency allows pharmaceutical and biotechnology companies to directly advertise their products to consumers without devoting air time to listing all of the side effects found in the package insert.

Instead, the agency will require that television and radio ads mention major side effects and drug interactions and refer consumers to more complete information available from sources such as toll-free telephone numbers or the company's internet web page. "This marks a dramatic change in our policy," said Don McLearn, an FDA spokesman. "But, it doesn't loosen our standards."

The move also will mark the end of current television ads which endlessly mention a drug's name and manufacturer but fail to tell consumers what conditions the drug treats and what the drug does. Such ads more often confused consumers rather than offering them information about new treatment options.

"Kudos to the FDA for striking a blow for patients," Alan F. Holmer, president of the Pharmaceutical Research and Manufacturers Association of America (PhRMA), said in a prepared statement. "The new policy means that television ads will be more direct and user-friendly because advertisers will be allowed to name both the product and the condition it's meant to treat."

Under the old policy, pharmaceutical manufacturers could directly advertise their products to consumers via any media as long as they offered a "brief summary" of all important information about the drug or made an "adequate provision ... for the dissemination of the approved or permitted package labeling in connection with the advertisement." Print ads met this requirement by simply reprinting the adverse events and risk-related sections of the package label.

However, it is simply too expensive and cumbersome for pharmaceutical companies to go through such a list in a television or radio advertisement. As a result, advertisers would promote their products in the broadcast media without stating their benefits or risks.

The new policy allows pharmaceutical companies to advertise their products' indications and dispense with the laundry list of all possible side effects as long as they refer consumers to another source of that information. The agency offers four options which include a toll-free number that consumers can dial for mailed or faxed copies of the package insert, an internet address that provides the information, a reference to where to find print ads with the information or a statement that physicians and pharmacists could provide the information.

McLearn, however, noted the new policy doesn't mean a pharmaceutical company could hide a product's side effects in the additional material while touting the benefits of the drug. As is currently the practice, the agency must review and approve all drug advertisements. Major side effects and drug interactions must clearly be stated in the advertisement.

"The consumer really gains with this policy," McLearn said. "They will be able to get direct information about drug products and we are going to ensure that it is balanced."

The agency's move will have the most direct effect on established pharmaceutical companies that produce drugs with a wide market such as allergy medications and cardiovascular drugs.

Mass Market Biotech Ads Not Likely Soon

Approved biotechnology products, on the other hand, tend to be specialized for rare conditions where direct-to-consumer marketing would have little impact on their sales.

David Kaye, associate director for corporate communications at Amgen Inc., of Thousand Oaks, Calif., said the current change is likely to have "no impact at all on products like Epogen and Neupogen."

However, biotechnology companies are exploring treatments for more common illnesses like diabetes, arthritis, and obesity which would be expected to have large markets. For example, Amgen holds the rights to leptin and the leptin receptor and is actively developing potential treatments for obesity.

"Should leptin prove to be useful as a pharmaceutical, it might be a product worth marketing directly to consumers," Kaye said. "It sounds like the agency has found a way to recognize the limitations of television. Pharmaceutical manufacturers are going to advertise; they might as well find a way to let them do it." *