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BUSH ADMINISTRATION "CONCERNED" ABOUT FDA's DRAFT SYMPOSIA/CME GUIDELINES; BOSTON UNIV. PROF CHARGES FDA RULES WILL SET UP BLACK MARKET FOR DRUG INFO

Executive Summary

The Bush Administration is "concerned" about FDA's draft concept paper on company-sponsored symposia and continuing medical education programs, White House Counsel C. Boyden Gray told the American Enterprise Institute's Annual Policy Conference in Washington, D.C. Dec. 3. Gray said FDA's proposed rules for distinguishing between legitimate educational programs and promotional events could act "to restrict" the flow of information on unapproved drug uses. The White House official warned that FDA's action "does not auger well." The White House's concern is another indication of the awareness of FDA affairs within the Bush Administration. FDA's high visibility campaigns against food and drug promotions apparently are having two contradictory effects: (1) assuring good general press for Commissioner Kessler; and (2) earning a degree of skepticism and quiet disapprobation from the Administration hierarchy. Signs of the closer attention to FDA from above are evident in several recent moves. The choice of the associate commissioner for public affairs at FDA, for example, exhibits one level of White House oversight. Gary Fendler, who assumed his post at FDA on Nov. 25, has solid GOP political credentials and a long background of working for Bush campaigns. It is not unusual to reward a loyal worker with an appointment like the FDA position, but the choice also serves to assure that FDA's public face will be in tune with White House political objectives. At a different level, HHS is interviewing candidates for an FDA liaison position to keep HHS topside in closer touch with FDA iniatives. Again, the position is not unusual. However, it is emblematic of an attempt by Kessler's superiors in the administration to keep better tabs on FDA. The Bush Administration's most widely publicized foray into FDA affairs was the recent announcement of an FDA drug approval reform plan formulated by Vice President Quayle's Council on Competitiveness. Those reform proposals have sparked some opposition from within FDA and on Capitol Hill. Sen. Kennedy (D- Mass.) and Reps. Dingell (D-Mich.) and Waxman (D-Calif.) asked FDA not to implement the proposals made by the competitiveness council until they have been reviewed by Congress. (see following story). Gray's remarks to AEI followed a presentation by Boston University School of Management professor John Calfee on "FDA Regulation: Moving Toward a Black Market in Information." Declaring that "the drug companies are the ones who know the most about unapproved uses," the Boston University professor stated that for FDA "to micro-manage promotion by pharmaceutical firms is to deprive the market of its most effective informational tool, and therefore, of the single most potent force for the development of new uses for existing drugs." Calfee maintained that FDA has an "inveterate suspicion" of all information disseminated by a party with a financial interest in the communication of that information. He declared that FDA should reconsider that position, suggesting that the "market works quite well" in controlling the use that is made of public information. The Boston University professor further urged that FDA "reconsider its entire regulatory apparatus," stating that FDA has "heavy artillery" it can bring to bear. Calfee suggested that the two roles of regulation and drug approval should be performed by separate agencies to prevent FDA from using its power over approvals as a cudgel to enforce other rules. Calfee also echoed concerns voiced by the Pharmaceutical Advertising Council at a Nov. 21 meeting in New York City. He observed a "catch-22 situation" between FDA's policy against providing symposia attendees with reimbursement for travel expenses and its suggested rule that companies hold a symposium only once. Through FDA's control on promotion of unapproved uses, Calfee said the agency is treading on the right to free speech. "Even First Amendment law becomes irrelevant (despite the fact that FDA routinely prohibits statements that by any standard are completely true)," Calfee said. Addressing this concern at PAC on Nov. 21, FDA Associate Chief Counsel for Drugs David Adams explained FDA's position that "commercial speech" can be regulated constitutionally ("The Pink Sheet" Nov. 25, p. 9). Also addressed by Calfee were FDA's recent food labeling regulations, which propose to disallow labeling reference to the health benefits of several categories of food (e.g. dietary fiber for prevention of colon cancer). Calfee suggested FDA "adopt an approach that recognizes the benefits from informational competition." He asserted that "health claims in advertising quickly moved consumer information and choices toward what nutritionists have long recommended." Calfee warned that FDA's new regulations will lead to "second order effects," such as "less production and dissemination of nutritional information" and "a decline in the nutritional improvements in foods."

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