Academic journal article Public Relations Journal

FDA Drug Promotion Regulation: More Heat - and More Confusion?

Academic journal article Public Relations Journal

FDA Drug Promotion Regulation: More Heat - and More Confusion?

Article excerpt

FDA drug promotion regulation: More heat - and more confusion?

After eight years of confusion, the U.S. Food and Drug Administration has said that later this year it will at last release guidelines defining what it considers to be "misleading" publicity claims about drugs. At the same time, the agency, which has long regulated claims in advertising and labelling for products controlled under the Food and Drug Act, is making it clear that it will be beefing up its regulatory activities in the promotion area.

Many public relations practitioners, who have been frustrated by the FDA's ambiguity since the agency made its first regulatory effort regarding promotions in 1982, say they are either skeptical about whether the regulations will clear up the confusion or fearful that they will go too far.

Currently, the FDA admits it's still struggling to come up with such guidelines and that "a lot of gray areas" still exist. Up to now, the FDA has been applying its existing regulations to promotions on a case-by-case basis. "This is a fairly new area that we've begun to work in," says Kenneth R. Feather, acting director of the FDA's Division of Drug Advertising and Labelling. Despite the problems, however, Feather says his agency is now "turning up the regulatory heat."

Health care practitioners say the lack of clear-cut guidelines has placed an unfair burden on them, making it difficult to determine in advance which promotional materials are acceptable and which are not. Each case, they say, surfaces for different reasons and involves different promotional activities. "Right now, the FDA's guidelines are a little bit arbitrary," says Gail Safian, vice president/director of health care communications for Cohn & Wolfe, New York. "It makes it very hard to do business. It's almost unfair to say that a certain promotion may or may not be OK."

Will guidelines help?

Some health care communicators feel some of the confusion will be cleared up when the FDA issues its first promotion-specific guidelines. Others, however, argue that publication of the guidelines will signal an end to the "education" stage, resulting in increased FDA regulation. There is also some concern that the guidelines will be far too general to help at all. Most expect a great deal of debate between the FDA and health care practitioners when the proposed guidelines are made public for comment prior to publication of final rules.

The FDA itself thinks it might very well take a legal case to settle some of the murky issues. Feather says the FDA "is not actively" seeking such a case at this time, but confirms that it's an option the agency "will not turn away from."

Most health care practitioners interviewed by PRJ contend that a test legal case would accomplish little or nothing. Some believe it would make matters worse. "Any test case will probably be a situation in which a company has flagrantly and consistently violated the intentions of the FDA," explains Wayne Pines, executive vice president of health care for Burson-Marsteller, Washington, D.C. "And if the FDA wins, it will probably just indicate that they have jurisdiction in this area, rather than provide any real guidance."

Truth and balance

At issue is the growing use in recent years of what Feather describes as "non-traditional" advertising, most of which is aimed not at physicians, but directly at consumers. …

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