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Executive Summary

SUPERPHARM EX-EXECS AZEEM AND MANNAN SET FOR SENTENCING APRIL 24 in Baltimore federal court. Former Superpharm VP-Technical Services Mohammed Azeem was found guilty Feb. 12 by a federal court jury on three courts involving false submittsions to FDA, and former Superpharm R&D department manager Muhammed Mannan was found guilty on two of three counts by the same jury. The two former generic drug industry execs were each charged in May 1991 with one count of conspiracy to make false statements about ANDAs and two counts of filing false statements for two ANDAs ("The Pink Sheet" May 6, T&G-3). Azeem and Mannan each face up to five years in prison and $10,000 fines. Azeem already has served a six-month sentence for offering illegal gratuities to FDA employees when he worked as a consultant to American Therapeutics, Inc. after he left Superpharm in 1986. The conspiracy count on which Azeem and Mannan were found guilty involved "falsification of batch records, test data, inventory records and laboratory reports to cover up their actual deficient procedures and results," a Maryland U.S. Attorney's Office press release says. The conspiracy involved the following drugs: hydralazine HCl 50 mg/hydrochlorothiazide 50 mg capsules; ibuprofen 400 mg tablets; diazepam 2, 5, and 10 mg tablets; lorazepam 0.5 mg tablets; and propranolol HCl 10 mg tablets. The hydralzain/hydrochlorothiazide product was never marketed. All of Superpharm's ANDAs eventually were withdrawn. In addition to problems with the seven generic products named in the criminal charges, the trial also disclosed problems with two other Superpharm ANDAs -- chlorpropamide and quinidine gluconate -- as far back as 1984. Falsifications of stability tests on chlorpropamide occurred while Azeem was at Superpharm. He was said to have instructed employees not to record the addition of the lubricant magnesium stearate into the production of quinidine to solve sticking problems and to have made the additions without filing a supplemental ANDA. Azeem and Mannan were also found guilty of making false statements to FDA for propranolol HCl tablets. In the ANDA, they "misrepresented the batch size actually produced, the date the lot was produced, the lot number of the active ingredient actually used, and the color ingredients," the U.S. Attorney's Office said. The jury also determined that Azeem was guilty of making a false statement to FDA for the hydralazine HCl/hydrochlorothiazide filing. Mannan was found not guilty on this charge. The jury trial of the two men began on Feb. 3 and closing arguments were heard the morning of Feb. 12. The jury of four women and eight men deliberated until early evening before returning the guilty verdicts. The case was prosecuted by Assistant U.S. Attorney Raymond Bonner and Lawrence McDade of the Justice Department's Office of Consumer Litigation before Judge John Hargrove, who has presided over all the cases brought to the Baltimore federal court so far in the ongoing generic drug scandal. The star witness for the prosecution was Liaquat Hossain, an ex-manager of Superpharm's product development. Hossain pled guilty to one count involving false statements made for propranolol 10 mg tabs and agreed to cooperate with the investigation. He is currently scheduled to be sentenced on March 10. Hossain joined Superpharm in early 1981 as a chemist in the company's production QC department. In late 1984, he was promoted to the R&D production department to assist Azeem. Hossain testified that Azeem would provide him with handwritten formulas for R&D batches and later asked him to take handwritten batch record notes and "put them into nice submissable form" for FDA. In essence, the prosecution argued, Hossain, who had no experience with FDA batch record requirements, learned by doing. Hossain also testified that the R&D lab was on notice to submit two ANDAs per month causing constant backlogs in production batches. Due to the increased ANDA demands, more people eventually were hired, including Mannan, who also was later put to work filling out batch records. Among the types of allegations reviewed, prosecutors said that when told by FDA that batch testing of diazepam 2 mg required a minimum of 60,000 tablets, rather than the 20,000 actually used, Hossain and Mannan, at the direction of Azeem, simply multiplied the numbers in the ANDA by three and resubmitted the data -- without performing any new tests. For other products, the defendants were involved in or aware of accelerated stability tests that were not performed at FDA-specified intervals. They also were aware of decisions to discard certain data from dissolution tests that would have indicated the products did not meet minimum standards, according to the prosecution. Lawyers for both defendants agreed that there were mistakes in the firm's ANDAs but denied any intent to defraud FDA. Azeem attorney Arthur Chezlock told the jury that while his client signed the ANDAs, as an executive he relied on employees for the content. There was a "discontinuous chain of activity" in preparing the ANDAs and a "discontinuous chain of responsibility," Chezlock argued. Noting that some of the tests reported in the ANDAs were conducted during Azeem's absence for medical treatment, Chezlock suggested that Hossain was responsible for much of the wrongdoing. The attorney used hospital records and company attendance charts to attempt to persuade the 12-person jury that Azeem was too sick with kidney problems to have overseen the manipulation of product records. McDade responded that all the submissions were made in 1985 before Azeem became ill. Chezlock tried to undermine the credibility of Hossain's testimony by noting the fact that Hossain had agreed to cooperate with the government. Mannan's attorney, George McDowell, depicted his client as a junior and naive employee, who filled in parts of the ANDAs at the direction of others without being aware of their full significance. McDowell said that "Zach [Mannan] was never aware that he was falsifying information." Bonner stated that Mannan's defense is "the scarecrow defense." Noting that Mannan is very bright, had prior experience and three master degrees, Bonner said that "if I only had a brain is Mr. Mannan's defense; he was intimately involved in producing false documents." Witnesses called by the prosecution included FDA Office of Generic Drugs Chief of Program Support Staff Robert Pollock, Center for Drug Evaluation and Research Compliance Officer Barry Rothman and Division of Biopharmaceuticals Acting Director Henry Malinowski. The prosecution went through a lengthy comparison of the ANDAs, drug ingredient inventory cards, official lab records and pages from chemists' personal notebooks, all provided to jurors in a three to four inch thick compilation.

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