CIBA-GEIGY's ACUTRIM IN OROS SYSTEM IS SAFER THAN OTHER SUSTAINED RELEASE PHENYLPROPANOLAMINE PRODUCTS, FDA COM. YOUNG TELLS REP. WEISS

Ciba-Geigy's Acutrim using Alza's slow release system has a safety advantage over other timed release phenylpropanolamine products, FDA Com. Young told Rep. Weiss (D-NY) in a March 1 letter. Young said in the letter that "an important concern about sustained-release phenylpropanolamine products is that the products might deliver too much phenylpropanolamine at once, thus posing a safety problem. Acutrim appeared to be superior in this respect to other products, and, therefore, safer." FDA said that following the agency's initial decision that Acutrim was a new drug requiring an approved NDA for marketing, Ciba-Geigy submitted information "comparing the blood levels of phenylpropanolamine achieved by Acutrim with the blood levels achieved using other marketed sustained-release phenylpropanolamine products." Young stated that the information submitted by Ciba-Geigy "demonstrated that the OROS system worked well in terms of delivering phenylpropanola mine to the blood system and that the system produced better results than those already on the market in terms of providing a sustained release of the active ingredient." Young's letter responds to a Dec. 27 inquiry from Weiss in which the congressman asked FDA to explain its regulation of Acutrim. Weiss also asked FDA to identify all other OTC timed-release products on the market which are "new drugs" and not subject to an approved NDA. The agency stated that at the present time it is "unable to identify all OTC timed-release products on the market which are 'new drugs' without approved NDAs." Young noted: "We do not maintain a list of OTC drug products that have been investigated and found to meet the deferral requirements of the [OTC enforcement] policy . . . Development of such a list would involve an exhaustive file search going back to the beginning of the OTC Drug Review program." FDA noted, however, that its current data on marketed OTC drug products consists of 30,000 OTC drug products with and without approved NDAs which have been put in the OTC computerized file; 35,000 OTC drug products for which data forms have been submitted by drug firms but not put into the OTC computerized file; and another 60,000-85,000 OTC products on the market which have not been listed by OTC firms. FDA concluded that "given the information indicating that the OROS system probably makes Acutrim safer than other sustained-release phenylpropanolamine products on the market, a determination that Acutrim cannot be marketed during the pendency of the OTC review weight control product rulemaking would require the agency to bring about an anomalous result: suspending marketing of an apparently safer product, whose market share would immediately be taken over by the other sustained-release dosage products that appear to be inferior." Young said the agency determined "Acutrim was more like already marketed sustained-release phenylpropanolamine weight control products than it was like a new product, and that, therefore, it was subject to the OTC enforcement policy." Under this policy, Young added, "Acutrim products may be marketed pending publication of a final OTC monograph on the drug." After publication of that monograph, Young said, "assuming that phenylpropanolamine products are found to be generally recognized as safe and effective," NDAs must be submitted for all sustained-release phenylpropanolamine products. In an earlier Jan. 30 letter to Weiss, Young noted there are an estimated 1,000 unlisted OTC drug products on the market that FDA would regard legally as unapproved new drugs that consitute health frauds. In that letter, Young said an agency review of all unlisted products, "even with sufficient manpower and resources," could not be completed in less than two years.