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EX-VITARINE VP-R&D COLTON PLEADS GUILTY TO RIGGING BIO TEST

Executive Summary

EX-VITARINE VP-R&D COLTON PLEADS GUILTY TO RIGGING BIO TEST results submitted to FDA. At a May 17 appearance before Baltimore Federal Court Judge John Hargrove, Steven Colton, PhD, pled guilty to three counts of making false statements to FDA and faces a maximum of five years in jail and/or a total of $ 750,000 in fines. The three false statement charges were filed against Colton in an April 24 criminal information ("The Pink Sheet" April 29, T&G-5). Colton's sentencing is set for Sept. 6 at 11 a.m. Maryland Assistant U.S. Attorney Gary Jordan presented evidence to Judge Hargrove that Colton illegally substituted six different innovator drugs for Vitarine's generic versions in submissions to independent bioequivalence testing labs. "Because of Dr. Colton's ruse, the brandname drugs were tested against themselves rather than against the proposed generic," a May 17 Maryland U.S. Attorney's office press release notes. The drugs submitted in the rigging ruse were identified as: albuterol sulfate extended-release tablets: loxapine succinate caps; methylprednisolone tabs; propranolol HCl sustained-release tabs; triamterene/hydrochlorothiazide caps; and verapamil HCl sustained-release tabs. Jordan reported that from triamterene/HCTZ's February 1988 ANDA approval until the generic version of SK&F's Dyazide was pulled from the market in May 1989, "Vitarine enjoyed over $ 11 mil. in sales" for the product. The May 1989 halt to Vitarine's sale of the generic antihypertensive/diuretic combo drug was part of the company's cease-marketing order for all 16 generics for which the firm had gained ANDA approval since 1986 ("The Pink Sheet" May 22, 1989, T&G-16). Colton, 39, was employed by Vitarine from October 1985 to July 1989 and was named a Vitarine VP in 1987, according to the Maryland U.S. Attorney. In August of 1989, FDA initiated the withdrawal of 25 Vitarine ANDAs for 13 drug products, including all the drugs pulled from the market in May ("The Pink Sheet" Aug. 28, 1989, p. 8). Further "misrepresentations" by Colton were presented to the Baltimore federal court May 17, including inflated bio batch records; "phantom" production records; and New York records represented as showing batch records from Vitarine's former facility in St. Croix, the Virgin Islands. Colton "on a number of occasions," provided FDA "with inflated figures" for R&D batch records, Jordan told Judge Hargrove. For example, Colton claimed in batch records submitted to FDA that 100,000 generic diazepam tablets had been made by Vitarine "when, in fact, only 10,000 were made," Jordan said. Colton also violated FDA requirements for generic antibiotics production by "making only one R&D batch and creating phantom production records for two additional batches that were never made," Jordan said. FDA requires that three R&D batches be produced and that test results be made available to FDA for each antibiotics pilot batch. The "phantom" records were then submitted to the agency. The substitution of records from one plant for another occurred, Jordan said, when Colton made batches in New York of an unspecified drug product, "but prepared production records that represented the work as having been done in St. Croix." Those false records were submitted to FDA in a supplemental ANDA. Additionally, Colton "admitted forging the initials of Vitarine employees on various production records," the Maryland U.S. Attorney's Office said. Vitarine said May 17 that "new studies confirming the safety and efficacy of most withdrawn products have been submitted to the FDA for review." The Vitarine response to Colton's entry of guilty pleas notes that "five" of the six products submitted by Colton as Vitarine generics "were never marketed" by Vitarine. Diazepam, "was also never marketed by Vitarine," the company stated. Vitarine noted further that the company informed FDA in July 1989 about the substitution of SK&F's Dyazide for Vitarine generic version of the drug and that "virtually all the allegations against Dr. Colton are based on evidence which was uncovered" by the firm's 1989 internal investigation. "The only exception," Vitarine said, concerned the allegation of Colton's substituting New York production records for St. Croix records in a supplemental ANDA. "Vitarine's investigation uncovered no evidence which supports such allegation," the company stated. Colton was suspended by Vitarine in July 1989 at the time of the ANDA withdrawals by FDA and later dismissed by the firm. The charges against him, filed on April 24, are the first involving Springfield Gardens, N.Y.-based Vitarine Pharmaeuticals. The Baltimore federal court is soon scheduled to arraign two of the three Superpharm former execs charged on May 3 with making false statements to FDA ("The Pink Sheet" May 6, T&G-3). Ex-VP Technical Service Mohammed Azeem will be arraigned June 7. Ex- product development manager Liaquat Hossain is scheduled for arraignment May 21 at 9:30 a.m. The whereabouts of Muhammed Mannan, the third ex-Superpharm exec charged, remain unknown.
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