FTC INACTION ON OTC IBUPROFEN ADVERTISING ALLEGED BY OUTGOING COMMISSIONER
FTC INACTION ON OTC IBUPROFEN ADVERTISING ALLEGED BY OUTGOING COMMISSIONER Michael Pertschuk in a 369-page critique of the Federal Trade Commission's performance between 1977 and 1984. Noting that FDA officials asked the commission's Consumer Protection Bureau to "play an active role in assuring that advertising for ibuprofen-containing drugs contain adequate warnings," Pertschuk asserted: "To date there has been no indication that the FTC has moved to make certain that the advertising by drug manufacturers to promote ibuprofen products contains adequate cautionary warnings." Pertschuk echoed Health Research Group Director Sidney Wolfe's concern that the omission of aspirin sensitivity warnings in retail ads could mislead people with aspirin sensitivities to believe that ibuprofen is safe for them to use. "While FDA requires label warnings about the risks of ibuprofen to those with aspirin allergy, there remains great concern that such warnings to consumers are inadequate if consumers buy the drug directly on a non-Rx basis," he said. The outgoing commissioner, whose term expires Sept. 25, also cited the restriction of OTC ibuprofen sales by Illinois pharmacists who claimed consumers "need more information about the possibly damaging side effects before they take the drug." Pertschuk's report was in response to a request from House Oversight Subcmte. Chairman Dingell. In an Aug. 24 letter to Dingell, FTC Chairman James Miller called the report "the predictable venting of final rage by a chronic complainer" and suggested the report "might better be entitled: 'The Performance of the FTC, 1981-1984: A Minority View.'" Asked by Dingell for an analysis of Pertschuk's report, Miller said: "Our initial review of this document reveals a manuscript riddled with factual errors and distortions of varying degrees: unsubstantiated claims, half-truths, misrepresentation and faulty logic." Miller's staff is currently preparing detailed comments on the report, he said. Pertschuk, who has been on the commission since 1977, served as chairman during the Carter administration. Although his successor at FTC has not been formally announced, President Reagan has indicated that he will name FTC Assistant General Counsel for Legal Counsel Mary Azcuenga to fill the seat. Azcuenga has been with the commission since 1973. In his comments on drug advertising, Pertschuk also cited an April 1982 request by the Center for Science in the Public Interest to investigate "all weight control products containing phenylpropanolamine." Pertschuk said FTC, "after a lengthy delay, finally sent mfrs. of diet pills a synopsis of a commission case law putting them on general notice of the law's requirement with respect to the diet claims." However, he contended, FTC "has yet to take any further action to assure that all diet pill advertising of phenylpropanolamine-containing products gives adequate warning." Pertschuk also criticized the commission's stance on a Bristol-Myers' promotion that would donate money to needy children on behalf of doctors who agreed "to write 30 Rxs for Bufferin 3 each month for a year." According to Pertschuk, FTC's Assistant Director for advertising practices "said the FTC had no objection and that: 'We would assume that doctors could withstand any pressure like that and only prescribe what is needed.'" In addition, the outgoing commissioner discussed his reluctant approval of the recently approved revised ad substantiation policy. Noting the only change in the new policy is the elimination of industry-wide substantiation "rounds," Pertschuk reiterated his earlier remarks that the rounds "would still have some value as a method of monitoring and encouraging compliance" with the substantiation doctrine. "I joined in supporting the otherwise innocuous policy statement with some reluctance," Pertschuk continued.
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth