The FDA, prompted by recent Supreme Court First Amendment advertising decisions, formally invited marketers and the public to comment on how its approach to ad regulation should change to reflect current Supreme Court thinking.
"This is one of the most significant happenings in the ad industry in the last decade," said John Kamp, a Washington, D.C., First Amendment lawyer.
Among the questions posed by the FDA: Can it constitutionally maintain that drug-marketing messages are automatically misleading unless they comply with FDA requirements? What sort of effects do direct-to-consumer drug ads have, and do current FDA rules meet constitutional tests? Can the FDA distinguish claims for vitamins from claims for foods, and what kind of evidence is necessary to term a claim misleading?
At the least, the First Amendment review could force the FDA to re-examine the limits it sometimes imposes on how and where marketers promote products, what can be said and whether truthful ads, minus certain approved wording, can really be challenged.
The FDA also asserts the right to regulate many forms of marketing communications beyond advertising, including marketer-financed "educational" programs for doctors. In the food category, marketers have sparred with FDA over its efforts to limit health and disease-prevention claims for cereals and other food products.
The FDA's new attention to First Amendment concerns also represents a not-so-subtle message to Congress, where critics of high drug costs are offering proposals to use tax penalties and other methods to curb spending on constitutionally protected commercial speech.
"Over the past few years, several courts, including the Supreme Court, have told the FDA in no uncertain terms that its regulatory requirements must pass muster under the First Amendment," Jim Skiles, VP-general counsel for the Grocery Manufacturers of America, said. "Hopefully the call for comments means the FDA has finally gotten the message."
In its most recent First Amendment advertising ruling, the Supreme Court April 29 struck down an FDA ban on druggist advertising of "compound" drugs not specifically approved by FDA.
The FDA's current chief counsel, Daniel Troy, a Bush administration appointee, is a First Amendment specialist. The agency traditionally asserts far-reaching, detailed authority over all marketing communications directed to physicians by prescription drug and medical-device marketers. It plays a less-prominent role in regulating advertising for foods and supplements, where it shares authority with the Federal Trade Commission. But it has used its powers to dictate the wording of allowable performance claims for over-the-counter drugs and to require limit health claims for some foods.