WYETH-AYERST "POSTPONING" PHENERGAN OTC MARKETING, the company informed physicians in an Aug. 4 "Dear Doctor" letter. Wyeth-Ayerst says it has put off OTC marketing of Phenergan (promethazine) for the time being, while FDA weighs the recent recommendation by its Pulmonary-Allergy Drugs Advisory Committee. At a July 31 advisory meeting, the committee declined to ratify FDA's existing NDA approval for OTC promethazine ("The Pink Sheet" Aug. 7, p. 10). "The recommendation by the advisory committee is now under examination by the FDA and we are discussing this further with the agency," Wyeth-Ayerst said. "Plans to market promethazine OTC have meanwhile been postponed." Although Wyeth-Ayerst uses the term "postponed," nonprescription marketing would be very difficult because of the threat of liability suits for the company to try to sell the product OTC against the record of the FDA advisory committee meeting. Wyeth told the physicians that the committee's concern about a possible association between promethazine and Sudden Infant Death Syndrome (SIDS) and infant sleep apnea was based on "scant information." Maintaining there "was not an affirmative finding of any association" between the drug and the syndrome, the company emphasized that the recommendation "reflected the committee's concern that there was insufficient data to exclude any possible relationship." Ayerst won FDA approval for an OTC version of promethazine with a 1988 supplemental NDA. The double jeopardy of a subsequent review by the prescription-oriented Pulmonary-Allergy Drugs Advisory Committee dramatizes the hurdles facing future Rx-to-OTC switches and may very well presage advisory committee reviews prior to any NDA switch. FDA is vulnerable to second-guessing on the original promethazine approval and is protected only by Wyeth's decision not to market the product. Based on the advisory committee discussion, it would appear difficult for the agency to try to revoke the OTC NDA. Phernergan will remain available as a prescription product. The company said that physicians "should continue to prescribe these products as directed with confidence of their proven safety." However, the company noted that since 1984, promethazine products have carried the warning: "not for children under the age of two." The approvals were for syrup products. Presumably, a solid dosage form would not face the questions of infant use. The agency sought the committee's advice in response to a petition filed in December by the Public Citizen's Health Research Group (HRG) and the University of Maryland's Sudden Infant Death Syndrome Institute. The petition sought a ban on OTC sales of promethazine-containing products. An issue raised by HRG and considered by the committee was the widespread use of promethazine in the population at high risk for SIDS -- children under the age of two years. FDA Office of Epidemiology and Biostatistics Director Gerald Faich, MD, estimated that 800,000 of the 11 mil. prescriptions for promethazine products are used by children under the age of two. * HRG said that even if promethazine products are not marketed OTC, it would continue to request that prescription promethazine-containing products bear a bold warning stating that promethazine has been associated with SIDS and infant respiratory depression.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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