FDA and ComSpeech

The Food and Drug Administration might not seem like a hotbed of First Amendment activity. Yet that agency has proved to be one of the most aggressive in attempting to restrict speech -- commercial and otherwise -- about pharmaceutical products and even about non-pharmaceutical products like tobacco.

The FDA asserts broad authority to regulate prescription drug advertising and has statutory authority (under the Food, Drug and Cosmetic Act) to regulate all drug product "labeling." This includes package inserts for consumers and promotional literature for physicians -- but the FDA has pushed the definition to include an expanding array of speech. As one FDA watcher summed up the agency's policy: "If a drug company pays for it, we can regulate it."

In essence, the FDA views speech about a drug and its uses as an integral part of the drug itself, and thus subject to regulation. First Amendment advocates, however, see that speech as meriting significant if not full constitutional protection.

The articles in this special section describe several of the FDA's speech-restricting initiatives that bear careful watching, as well as one hopeful note -- the agency's new guidance on televised prescription drug ads.


Agency Seeks Internet Policy To Regulate Next Frontier

It's not that the FDA hasn't noticed the new 800-pound gorilla of the information world -- it's just that the agency hasn't yet figured out how to wrestle it down.

The gorilla, of course, is the Internet, and the situation could change soon if the FDA comes out with a proposed policy governing on-line speech about drug products next year as planned.

The FDA asserts that it already has the power to regulate commercial speech about pharmaceuticals on the Internet, as in all other media, under the agency's statutory authority. In December 1996, for example, the FDA told the Liposome Co. to stop using a "misleading" home page description of its fungal medicine, Abelcet. The agency is also on the lookout for manufacturers using their Web sites to promote off-label uses for their drug products.

What regulators are finding murkiest, however, are the Internet's unique aspects like chat rooms and links to other sites. These forums for third-party communication are raising an old question in the new on-line environment: When is speech about drugs "advertising" or "labeling" (and thus subject to FDA scrutiny) and when is it just speech?

FDA authority James M. Johnstone, a Washington attorney, points to another significant hurdle that any Internet regulatory scheme will face: the global nature of the Net. "If a certain drug use is approved in Europe but not in the United States, and that information can be accessed on the Internet here, how do you regulate it?"

The FDA is grappling with such questions. "We have tried to elicit comments from various groups" to reach a policy that "doesn't stifle the dissemination of information but provides consumers with some protection," said Brad Stone, FDA press spokesman.

In a two-day session in October 1996, the FDA heard from nearly 90 participants representing health care, legal, media, technical, academic, consumer, and governmental interests, in addition to over 40 FDA staff.

Stone contends that pharmaceutical makers will welcome a formal policy. "Right now the industry doesn't have a sense of how far they can go or what they should do," he said. "They're looking for a level playing field." The agency is operating on a case-by-case basis at present, Stone said, but hopes to issue proposed regulations or guidance in the first part of next year.

Controversial Tobacco Ad Rule Awaits Court Decision

The FDA's boldest foray into commercial speech regulation -- its unprecedented attempt to restrict advertising about tobacco, a non-pharmaceutical consumer product -- quickly landed the agency in court where the outcome now rests in the hands of the Fourth Circuit.

That appellate court is expected to rule soon on whether the FDA has statutory authority under the Food, Drug and Cosmetic Act to regulate tobacco products and tobacco advertising. The court heard oral arguments Aug. 11.

Last April, the U.S. District Court for the Middle District of North Carolina rejected the FDA's contention that it had statutory authority to regulate tobacco advertising but stopped short of reaching the First Amendment argument. The court did rule, however, that the FDA had statutory authority to regulate tobacco products themselves as medical devices.

The brouhaha started in August 1995 when the FDA unveiled a proposed rule that would impose sweeping restrictions on the sale and marketing of tobacco products. A final rule that was similar in most respects followed in August 1996.

The controversial rule hinged on the assertion that nicotine was a drug and that cigarettes were "drug delivery systems" -- and thus subject to FDA regulation. The rule's advertising restrictions would ban billboards within 1,000 feet of schools and playgrounds; limit other billboards and ads in many magazines to black-and-white text only; ban brand-name sponsorship of sporting and other events; and ban brand names on hats, T-shirts, and other non-tobacco items.

Tobacco and advertising interests filed suit in federal court, claiming the FDA was asserting authority it did not possess over both the product and its advertising.

In a separate action last June, however, tobacco manufacturers reached agreement with state attorneys general to restrict advertising in these and additional ways. But that settlement has yet to be implemented and could still fall apart.

The spotlight thus shifts back to the Fourth Circuit, which must rule on the FDA's regulatory gambit. If the industry settlement collapses, the future of tobacco advertising may well hinge on that Fourth Circuit opinion -- at least until the action moves (as it most likely will) to the Supreme Court.