Firms Pressure FDA to Relax Rules on Commercial Speech
CHRIS ADAMS / Wall Street Journal 17sep02
WASHINGTON -- The food and drug industries are pushing federal regulators to loosen longstanding restrictions on promoting their products, setting themselves up for a bruising clash with congressional critics who think such a move would endanger consumers.
At stake is the way the Food and Drug Administration handles a wide array of advertising and marketing issues, including how pharmaceuticals makers peddle their wares to doctors, how food producers label their products and how medical-device makers inform the investing community about potential new products.
Because the FDA regulates products accounting for 22% of U.S. consumer spending, its restrictions on these "commercial speech" issues can have an immense impact both on consumer and producer behavior.
Responding to the FDA's offer to review its rules and its solicitation of public input, the industry is pushing for both wholesale and tiny changes. Pfizer Inc. wants the FDA to ditch a rule that requires manufacturers to prominently place the generic name for a drug alongside its branded name in advertisements. Such "old, paternalistic traditions" simply "cannot withstand First Amendment scrutiny" today, Pfizer said in comments recently filed to the agency. The New York company also wants the FDA to drop its requirement that drug makers list possible side effects in reams of fine print in magazine ads.
Regulatory lawyers are unsure how long the FDA review will last, but are certain some rules will go. "Am I a good predictor of which ones? Absolutely not," says Peter Barton Hutt, a former FDA chief counsel now working on behalf of a grocery-manufacturers group and a venture-capital association. "But the important thing is, all of the FDA's policies are being put under scrutiny."
In May, the FDA, spurred by a string of adverse court decisions on commercial-speech issues, asked for public comment on its current rules. The agency wanted to know if its rules advanced public health or whether "alternative approaches" would be better. Industry groups and companies jumped at the chance, as did the American Civil Liberties Union, which urged a "less restrictive" approach. Comments were due last Friday.
Those pushing a rules retreat are encouraged that the person leading the review is Daniel Troy, the FDA's chief counsel. Before leaving his law practice to join the Bush administration, he was known for taking on the FDA over marketing and promotion issues.
"Some of the people at the FDA place a higher regard on First Amendment rights than perhaps others did in the past," says Richard Samp of the Washington Legal Foundation, a free-market advocacy group that worked with Mr. Troy to sue the FDA over some rules in the late 1990s. Mr. Troy also was involved in challenging agency efforts to restrict tobacco ads.
But influential Democratic lawmakers and others, such as the advocacy group Public Citizen, assert that FDA rules are vital to the public health. The American Medical Association cautions that "the FDA should not be deterred" in regulating what medical-products makers say about their goods.
Congressional critics are especially opposed to any relaxation of the rules governing "off-label" drug promotions -- that is, plugging medicines for uses other than the specific ones for which they were approved. The FDA approves most drugs for specific uses, although doctors can prescribe them for other uses. Companies, however, aren't allowed to advertise such off-label uses.
"The First Amendment shouldn't force us to return to a time the public health would be endangered -- where manufacturers can profit by giving misinformation or deceptive information, and where it could be years before any product could be taken off the market," says Rep. Henry Waxman, a California Democrat.
Mr. Waxman and eight other Democrats, including Massachusetts Sen. Edward Kennedy, chairman of the Senate health committee, warned in a letter to the FDA that "Americans could lose their lives" if the agency rules are eased. The lawmakers were especially incensed that changes were being weighed without a permanent commissioner in place; the FDA's current leader, Lester Crawford, is serving as interim commissioner and thus isn't subject to Senate confirmation.
On the Republican side, House Energy and Commerce Committee Chairman W.J. "Billy" Tauzin of Louisiana, acknowledges the FDA's watchdog role but says that role needs to be carefully considered. "I think that if a product is legal, we ought to be able to talk about it publicly without government restricting our conversation," he says.
The FDA essentially has two jobs: to determine whether products are safe and effective, and to ensure they are marketed responsibly. The agency's speech-related rules have evolved in recent decades, as the FDA seeks to meet Supreme Court tests for restrictions on commercial speech. The high court has held that false or misleading commercial speech can be banned. As for truthful commercial speech, the court has said it can be limited if the government can show the restrictions are necessary for the public good and aren't more onerous than necessary.
But even as the FDA has made some changes, the industry has remained dissatisfied. The Pharmaceutical Research and Manufacturers of America, the drug industry's main trade group, wants looser rules on what information drug makers can hand out detailing off-label uses of approved drugs.
For example, if a researcher publishes a paper -- even in the totally independent and prestigious New England Journal of Medicine -- that analyzes an off-label use of a drug, sales representatives used to be prohibited from handing a reprint of the article to doctors. Such an act was seen by regulators as promoting the unapproved use. The FDA has backed away from that stance recently because of a court setback, but hasn't given companies the green light to widely disseminate such literature, the industry says.
"To this day, the ground rules remain unclear," says Matthew Van Hook, PhRMA's deputy general counsel.
Drug makers, as well as the National Venture Capital Association, which funds biotechnology start-ups, say the FDA's policy essentially takes neutral, truthful information and applies a double standard: An independent researcher can freely hand out such a reprint, while the maker of the drug can't.
Companies also are pressing the FDA to ease up on its regulation of news releases that highlight research results. PhRMA says the FDA has cited companies for improperly describing "encouraging preliminary studies" for drugs. The trade group argues that approach "impermissibly burdens speech."
Pfizer, in its comments, also criticizes the FDA division that reviews drug ads. Senior corporate counsel Arnold Friede says some letters admonishing companies for their ad content go too far. "You could make the case that many of them are based on subjective interpretations of an ad that consumers might not share."
Mr. Friede says Pfizer would like to have some sort of "neutral arbitrator" that would listen to drug-company appeals. FDA defenders say tough enforcement of the rules is necessary to protect consumers from the sometimes exaggerated claims of pharmaceuticals makers.
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