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PHENYLPROPANOLAMINE DEFERRAL FROM FINAL OTC MONOGRAPH

Executive Summary

PHENYLPROPANOLAMINE DEFERRAL FROM FINAL OTC MONOGRAPH for nasal decongestants was protested by D.C. law firm Morgan, Lewis & Bockius in an Aug. 15 request to FDA for an advisory opinion. The firm requested that "the commissioner confirm that the Nasal Decongestant Final Monograph properly should not and will not issue until completion of the review of phenylpropanolamine for that OTC drug indication." Based on informal reports by FDA officials, the firm said FDA plans to publish the OTC Nasal Decongestant Final Monograph in the Federal Register "in October or November of this year." According to the firm, the agency rule will defer the monograph review of phenylpropanolamine, "but permit its continued marketing pending completion of review of that drug." The monograph is expected to include the statement: "Because of unresolved safety concerns relating to phenylpropanolamine, review of this ingredient will be deferred." Phenylpropanolamine is an active ingredient in a variety of cold medicines, including Fisons' Allarest, SmithKline Beecham's Contac, Robins' Dimetapp, Bristol-Myers Squibb's Naldecon and Sandoz' Triaminic. Phenylpropanolamine is also an active ingredient for several diet aids, including Ciba Consumer's Acutrim and Thompson Medical's Dexatrim. FDA recently said that it plans to propose the removal of all weight control products containing ingredients other than phenylpropanolamine and benzocaine. FDA has been considering the available data to determine whether phenylpropanolamine induces a significant hypertensive effect on blood pressure. Data submitted by companies in response to a May 1989 request for dosing studies on phenylpropanolamine are being reviewed by the Division of Cardio-Renal Drug Products. One study conducted with the phenylpropanolamine-containing weight control product Dexatrim showed that phenylpropanolamine increased diastolic blood pressure by two to four millimeters of mercury, an effect which, according to the investigators, was clinically insignificant ("The Pink Sheet" June 19, 1989, T&G-10). At a recent House Small Business/Regulation Subcommittee hearing, FDA Center for Drug Evaluation and Research Director Carl Peck, MD, said the review of phenylpropanolamine data should be complete by November ("The Pink Sheet" May 14, T&G-6). If FDA issues the final monograph while deferring the review of phenylpropanolamine, "it in effect will be creating and sanctioning a post-final monograph Category III OTC drug, in violation of the Act," the firm maintained. In addition "[phenylpropanolamine] will be placed at a significant competitive disadvantage to other nasal decongestant ingredients that are included in the final monograph," the firm said, noting that competitors will be able to take advantage of the monograph's reference to "unresolved [phenylpropanolamine] safety concerns' as grist for their comparative marketing campaigns."

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