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Executive Summary

American Home Products' generics subsidiary, Quantum Pharmics, is voluntarily recalling seven drugs in light of evidence that misrepresentations of batch sizes were submitted to FDA in support of the ANDAs. "These actions stem from findings of an ongoing company audit, conducted in conjunction with the FDA, that these products were approved by the FDA on the basis of false information filed by the company's prior management," AHP said in an Oct. 19 release. AHP reached an agreement with FDA on Oct. 17 to initiate a Class II recall. Quantum is recalling minoxidil, doxepin, and trazodone at the retail level and clorazepate dipotassium, meclofenamate, diazepam and lorazepam from wholesalers. Lorazepam (marketed as Ativan) is a Wyeth-Ayerst brand. FDA determined the different recall levels based on the agency's assessment of the medical significance of the individual products, AHP noted. "There is no indication of any safety or efficacy concern with any of [the] recalled products," AHP stated in the release. In September, Quantum temporarily suspended distribution of its entire generic line of 21 products in order to facilitate FDA's ongoing inspection and internal audit of its plant ("The Pink Sheet" Sept. 25, p. 7). At that time, FDA discovered record discrepancies with Quantum's ANDAs for minoxidil, clorazepate and meclofenamate. In an Oct. 20 Talk Paper, FDA said that it requested the recall of minoxidil, clorazepate and meclofenamate "because the size of the production run submitted for testing to gain FDA approval was in each case misrepresented as much larger than it actually was." In addition, with meclofenamate "it was uncertain whether the product formula tested is the same that was approved and is being marketed," the Talk Paper says. FDA noted that AHP agreed to recall the other four drugs because of misrepresented data in ANDAs for those products. Quantum is one of the 20 leading generic drug manufacturers under investigation by FDA in its second phase of inspections. On Sept. 20, Rep. Dingell (D-Mich.) sent AHP Chairman John Stafford a letter requesting records on Quantum, including financial documents related to AHP's purchase of the generic firm. Dingell's letter noted that he had earlier asked AHP for information on Quantum in July 1988. The congressman's recent letter requests documents associated with with "any internal investigation or review of Quantum conducted by or for [AHP] after July 13, 1988." Dingell also asked for records on FDA inspections dating from the present back to Jan. 1, 1985. In addition, Dingell questioned AHP as to why it did not initiate an investigation of Quantum's ANDAs after the subcommittee's initial inquiry. AHP gained controlling interest in Quantum in March 1986 and later completed the acquisition. Quantum was established in April 1983 by several former Premo Labs execs, including John Blackman and Jin-Shung Chang. At a July 11 hearing of Dingell's House Commerce/Oversight Subcommittee, former Division of Generic Drugs Director Marvin Seife testified that during January 1986 and mid-1987 he diverted Quantum's ANDA applications, as well as applications from other firms, away from ANDA Review Branch III Chief Charles Chang. Seife said he was concerned that Chang might show favoritism towards Quantum and the other companies ("The Pink Sheet" July 17, p. 13).

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