FDA Seeks Public Comment on Constitutionality of Regulations for Product Labeling, Advertising

In an "unusual" move, the FDA is asking for public comment on "whether its regulations and policies on product labeling and advertising" comply with the First Amendment "in light of recent decisions by federal courts," the Washington Post reports. While the request neither "specif[ies] what policies might be questionable" nor "indicate[s] what actions might be contemplated in the future," it "demonstrate[s] the agency's eagerness to address some highly contentious issues about how it regulates the food and drug industries," the Post reports. Those industries have frequently complained that FDA rules regarding product labeling and advertising are "overly strict"; in several cases the courts have agreed. For instance, the Supreme Court last month struck down an FDA ban on advertising by pharmacists who compound medications, saying the ban was an unconstitutional violation of free speech. The FDA notice, published yesterday in the Federal Register, states, "Not only have some of these [legal] decisions thwarted actions FDA has wished to pursue ... but they may threaten to diminish the overall legal credibility necessary for FDA to sustain its authority to accomplish its important public health duties." An FDA official added, "It's no secret that we've lost some cases on First Amendment grounds. We will continue to regulate, but are not playing ostrich with our heads in the sand. ... We want to have a conversation with the public about this." The notice allows the public 75 days to submit comments and an additional 120 days to respond to comments.

The FDA's move could benefit the food and drug industries, the Post reports. In the request for comment, for example, the agency asks whether food and drug companies should be regulated more like the dietary supplement industry, which is "largely exempt" from FDA advertising and labeling rules as a result of congressional action and several court decisions. The possible loosening of food and drug industry regulation concerns some advocates. "The notice appears to reflect the intention of the [Bush] administration to explore using the First Amendment to weaken the [FDA's] ability to ensure the truthfulness of statements by drug and food companies," William Schultz, a former FDA deputy commissioner, said, adding, "If the FDA adopts that course, it will gut the public health protections for food and drug advertising that consumers have enjoyed for more than 40 years." Bruce Silverglade of the Center for Science in the Public Interest said he is concerned that some FDA officials are "wrapping commercial speech in the First Amendment and using it as license to practice quackery." But Richard Samp of the Washington Legal Foundation, which sued the FDA over a regulation involving advertising of drugs for off-label purposes, said, "It's not every day that the FDA seeks comments on constitutional restrictions on its power. People in the Bush administration have a different view than some of their predecessors. If new restrictions on FDA power are to be put in place, now is the time to do it" (Kaufman, Washington Post, 5/15).