Last Updated: 2002-05-16 9:55:30 -0400 (Reuters Health)

By Ori Twersky

WASHINGTON (Reuters Health) - The US Food and Drug Administration (FDA) announced Wednesday that it plans to gauge public opinion on whether its product labeling and advertising restrictions are constitutional, in response to the FDA's loss of several recent court decisions on First Amendment grounds.

The FDA notice in the Federal Register gave interested parties 75 days to submit comments and another 120 days to respond to the comments.

At question is whether the FDA can legally restrict industry ads and labeling claims to those it has reviewed and agreed to. Courts have so far ruled that the FDA has the legal burden to prove that claims are false, while the FDA has argued that its public health mission is an overriding concern.

Last month, for example, the Supreme Court ruled 5 to 4 that the agency cannot ban pharmacists from advertising drugs that are reformulated or mixed from bulk supplies, although the FDA argued that it took the action to prevent the dissemination of false information. The justices said that the advertising prohibition violated free speech rights.

Meanwhile, lower courts have also held that the agency must adhere to the First Amendment, regardless of its public health mission.

The FDA said in the notice that it intends to continue regulating commercial speech. But the agency added that it now also wishes to learn whether the public believes the enforcement of these regulations helps advance the agency's public health mission.

Initial response to the FDA notice was mixed.

Critics warned that the agency might be looking for a way to ease its regulations at the cost of public health, while others applauded the FDA's self-examination as a step towards a more reasonable standard on what information the industry can share with the public.

Consumer groups said they are concerned because previous staff changes at the FDA already indicated that the Bush administration favors easing the regulations and allowing for unregulated commercial speech.

For instance, one Washington, DC-based consumer advocacy group observed that the Bush administration earlier appointed a chief FDA counsel known for successfully suing the agency on First Amendment grounds.

Traditionally, the agency has sought a congressional mandate when dealing with these issues, Bruce Silverglade of the Center for Science in the Public Interest told Reuters Health. But it now appears that the FDA is leaning toward embracing the industry's position, he said.

Silverglade added that it was the consumer group's opinion that public health would suffer if the FDA's ability to regulate such speech were to be further impeded.

"The bottom line is what impact commercial speech will have on public health," Silverglade told Reuters Health. "And while we can dicker about what's too tough, the public will certainly suffer."

Still, others argued that the FDA notice simply means the agency is realizing that it has exaggerated its role in terms of protecting public health and is now prepared to set a more realistic policy.

The notice can be read as the agency's recognition that it is not helping public health by limiting free speech, Richard Samp, chief counsel of the Washington Legal Foundation, a Washington, DC-based conservative legal think tank, told Reuters Health.

For instance, Samp said that while everyone agrees the FDA should act to prevent the dissemination of false information, the FDA notice could be seen as recognizing that preventing the release of information on potential off-label prescription drug uses, for example, could actually be harming public health.

Samp said the issue really boils down to a question of who has the burden of proof. But in claiming the right to assume everything is false until proven true, Samp told Reuters Health, it is not surprising that the courts are finding that "the FDA has exaggerated its place in the universe."

http://www.reutershealth.com/archiv...516elin017.html

In other words, let the buyer beware! And most buyers don't. But that's always been the case. Look at how well diet products sell.

;-Deb