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Executive Summary

PROMOTIONAL SYMPOSIA: SPONSORING COMPANIES SHOULD REMAIN INDEPENDENT from the organizational and planning function for medical symposia, FDA Drug Advertising Division Director Ken Feather told a Regulatory Affairs Professionals Society (RAPS) meeting Feb. 14. Feather asked companies to "stay as independent as possible . . . by letting . . . medical boards, universities, medical schools, medical associations, ]or other outside groups[ set up the topics and the speakers and moderate" the symposia. The outside group should also edit any publications coming from the proceedings of the meeting, he said. The FDA staffer recommended that the sponsoring company tell the organization setting up the meeting that it wants "a fair, accurate picture of what's going on." That "doesn't mean that you have to give them a list of speakers," Feather explained, "but just let them know that you expect the end result to be honest and fair and accurate." While FDA recognizes the value of symposia in the free exchange of scientific information, the agency has recently been signaling its intent to crack down on less than balanced presentations. "We accept the fact that a physician, scientist, researcher, ]or[ investigator can present his or her work to his peers, and we will accept that even in a totally firm-sponsored seminar," Feather said. "These activities can be legitimate," he noted, citing a recent FDA investigation of company-sponsored seminar programs that the agency found to be "well balanced" and "reasonably accurate." Feather explained, "We're not trying to stop seminars, . . . we're trying to ask that they be accurate and show a true picture of what the drug is." Commenting on FDA's regulatory position on symposia and other forums, Feather noted that his division has met with legal counsel and concluded "that many of these activities can be regulated as promotional activities under the FD&C Act, and we will be taking actions where appropriate and where possible in some of these areas." FDA recently issued a letter of adverse finding to Schering-Plough regarding a quasi-independent symposia the company has been conducting on Theo-Dur (theophylline) v. generic controlled-release theophylline products. The agency said the symposia were "false and/or misleading" and lacking in fair balance ("The Pink Sheet" Feb. 6, T&G-11). In an attempt to capitalize on the Schering incident, Forest Labs, whose competing product Theochron recently earned an "AB" rating, indicating therapeutic equivalence to Theo-Dur, sent copies of the adverse finding letter to pharmacists and physicians nationwide on Feb. 10. Discussing FDA's view on pre-approval advertisements, Feather said that the ads should be released "reasonably" close to the anticipated approval date. "If you're into final stages of your insert negotiations and you can reasonably expect approval within the next four to six months or so, it probably is not inappropriate to begin running some of the 'coming soon'" advertisements, he said. Feather noted that FDA regulations do not mandate footnotes in advertising and promotional material. "The only requirement is, if you make a claim, you must have the data to support that claim if we ask for it . . . If you reference something, you must have data to supply to whomever asks for that data, whether that be us or some outside person."(ITEM 200)#050928M001J59307# #970804M001XFCWP5# (ITEM 201)(COPYRIGHT) 1989 F-D-C Reports, Inc., The Pink Sheet, February 20, 1989

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