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It’s not often that a federal agency asks to be criticized. But that’s exactly what the Food and Drug Administration has done. The agency has opened up a no limits, bring-on-the-complaints conversation with the public about the First Amendment. Last spring, the agency asked for thoughts about whether FDA regulations on speech and advertising are constitutional and, if not, what should be changed. The agency gave the business community it regulates the opportunity to send in wish lists of rules they want to see overturned, softened or modified. The overture infuriated legislators including Sen. Edward Kennedy, D-Mass., and Rep. Henry Waxman, D-Calif., who demanded in a Sept. 13 letter that the agency immediately cease the inquiry. Lawmakers say the inquiry “contemplates stripping a vital public health agency of crucial powers.” Since May, hundreds of comments have been filed with the agency — from lobbyists and lawyers for business interests as well as from the public at large. And as the comment period drew to a close on Sept. 13, thick stacks of responses, complete with proposed new regulations, poured through the agency’s doors. “I think they did the right thing,” says Peter Barton Hutt, a former chief counsel of the agency who is now a partner at Covington & Burling. “I admire greatly an agency that is willing to come and say, ‘We recognize this is a new ballgame. Tell us where to go.’” Hutt filed two sets of comments on behalf of the Grocery Manufacturers of America, one of the food industry’s major representatives. The first set was a 57-page explanation of why the FDA must allow food companies to make certain health benefit claims about foods and nutrients. Others in the food and drug arena are viewing this unusual conversation with more apprehension, worried that it could be a move on the agency’s part to lift or loosen regulations on the type of advertising claims that pharmaceutical companies, food producers and dietary supplement manufacturers can make. “I think it’s extraordinary that the FDA has chosen to so comprehensively question its authority on some of its most important functions,” says William Schultz, a partner at Zuckerman Spaeder who previously worked at the FDA and the Department of Justice. He submitted comments on behalf of the Campaign for Tobacco-Free Kids. “I take it very seriously.” Over the last three years, the FDA has been on the losing end in the courts on speech issues. Food and drug lawyers all cite three significant cases. Two are from the U.S. Court of Appeals for the D.C. Circuit: Pearson v. Shalala, which involved health claims by dietary supplements, and Washington Legal Foundation v. Henney, concerning drug companies’ touting of “off label” or non-FDA-approved uses of their products to doctors. The third case, Thompson v. Western States Medical Center, was decided by the Supreme Court on April 29, 2002. The Court ruled that the agency’s ban on pharmacists advertising compound drugs they mix themselves was unconstitutional. A month later, the agency opened the doors to revamping its powers on free speech. FDA chief counsel Daniel Troy, a former Wiley Rein & Fielding partner who successfully battled the FDA in private practice, including the Washington Legal Foundation case, is credited with initiating the agency’s public outreach. Troy himself is as controversial as the agency’s call for comments. Two years into the Bush administration, the FDA is still without a commissioner, which makes Troy as chief counsel even more influential. His past has brought him critics, who fear that he is too much of a limited government advocate. But he has just as many admirers. His influence on this and other issues is praised by practitioners. “He is a First Amendment scholar and he is conscientiously asking for help in how the FDA should approach this issue,” says I. Scott Bass, a food and drug partner at Sidley Austin Brown & Wood who worked on comments for several clients. “I think he really is interested in getting ideas from the outside.” CONFLICTING VOICES What the FDA is hearing is as varied as the industry itself. Jonathan Emord, the lawyer in Pearson who specializes in representing dietary supplement manufacturers willing to battle the agency, says there is little acceptable about the current rules. The comments he drafted for his supplement clients, totalling about 160 pages, offered more than a dozen proposed regulations. “The regulations that govern speech are archaic and are totally out of sync with current First Amendment precedent,” he says. “The agency favors suppression over disclosure for food, drugs, dietary supplements, even cosmetics.” Many others chose a more moderate approach, picking specific areas of concern for their industry and pushing the agency to loosen its interpretations. The National Food Processors Association submitted comments on two items — mandated speech and health claims. The association argues against rules that mandate specific wording on certain foods, such as the warnings on foods that contain olestra, or on unpasteurized juice. The association wants companies to have the leeway to write their own warnings and other statements. The health claims issue is a long-standing battle between the food industry and the FDA. Pearson loosened restrictions on the claims supplements could make. Food companies want that same ability. “The way dietary supplements can now be marketed, they appear to be better for you than food,” says Regina Hildwine, the association’s senior director of food labeling and standards. “That is misleading. FDA has been permissive to supplements and not as permissive to food.” The Pharmaceutical Research and Manufacturers of America (PhRMA) urged the FDA to adopt a much more permissive policy for the distribution of information to doctors about other, not-yet-approved medical uses for drugs. Although the agency has grappled with that issue as a result of court challenges, PhRMA argued that the agency’s policies are still too restrictive. The group also argued against such FDA restrictions on what can be said in press releases and what can be promoted at scientific conferences. There were also citizen petitions. Hundreds e-mailed and wrote, most warning the agency to stay away from their dietary supplements and vitamins. “Dietary supplements are not drugs and should not be monitored by the FDA,” wrote one person. “I do not want the FDA making my decisions for me, or trying to limit my freedom of speech.” But for some public interest groups, such as Public Citizen and Health Law Advocates, the call for comments was an opportunity to ask the agency to tighten regulations on drug advertising or to beg them not to back off from those in place. “This is really the only protection the public has from snake oil salesmen,” says Abbey Meyers, president of the National Organization for Rare Disorders. “If [companies] are allowed to say [their] drug cures cancer, or arthritis, or you name it, we are back to the 19th century.” A number of lawmakers took similarly dim views. Sen. Jack Reed, D-R.I., sent a letter in July, expressing concern that the agency was overstepping its authority by suggesting it — rather than Congress — could overhaul the laws on speech and advertising. On Sept. 13, Rep. Waxman, Sen. Kennedy and several others sent their letter demanding that the agency stop the entire examination. “The Administration is contemplating action that flies in the face of almost a century of documented harm to the lives and health of Americans from unrestricted promotional claims about health-related products,” said the letter. “The attempt to restrict FDA’s authority over promotional claims is particularly offensive when the agency is operating without a Congressionally confirmed Commissioner.” Now the FDA must sort through the comments and pleas and start to make decisions. “I think that there may be a fair amount to examine. That doesn’t mean there is a fair amount to change,” says an FDA official. Those submitting comments will have until October to respond to each other’s filings. The agency is considering Sen. Reed’s suggestion to hold public hearings.

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