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HOUBA/MD PHARMACEUTICAL METHYLPHENIDATE DEA RULING RESCINDED

Executive Summary

HOUBA/MD PHARMACEUTICAL METHYLPHENIDATE DEA RULING RESCINDED by Administrative Law Judge Mary Ellen Bittner Sept. 9. In response to a motion filed by MD Pharmaceutical, Bittner decided to reopen the record in the case in light of regulatory actions taken against Houba's parent company, Halsey Drug. Bittner has set a deadline of Oct. 25 for Houba and MD to file new evidence in the case. On May 5, Bittner ruled in favor of Houba that its application for Drug Enforcement Administration registration for production of bulk methylphenidate be granted. Medeva subsidiary MD Pharmaceutical, the only producer of a generic methylphenidate (equivalent to Ciba-Geigy's IRitalin), opposed the registration. Bittner's May ruling partially shifted the burden of proof to applicants to show that they meet DEA regulatory standards, reversing a 1985 precedent ("The Pink Sheet" June 14, p. 12). "Bittner's Sept. 9 ruling does not appear to affect the portions of her May decision relating to burden of proof. The reopened hearing will focus on whether Halsey's recent settlements of criminal and civil proceedings have any bearing on Houba's eligibility for a DEA license. Halsey pled guilty to five counts relating to use of unapproved ingredients in its generic drugs and agreed to pay a $2.5 mil. fine June 21 ("The Pink Sheet" June 28, T&G-9). On June 29, the company entered into a consent decree with FDA covering its Brooklyn manufacturing facility ("The Pink Sheet" July 5, T&G- II). Five former Halsey execs, including former Senior VP- Technical and Regulatory Affairs Frederick Shainfeld, who had testified during the ALJ proceedings, were indicted July 12 ("The Pink Sheet" July 19, T&G-8). "The documents NM seeks to have me now consider have serious ramifications on this matter, if not on its outcome, then most certainly on its consideration," Bittner wrote. "They cast obvious doubt on my prior findings....In order, therefore, to discharge my obligation to present a full and fair record to the administrator, I am left with no apparent choice but to reopen the record and to consider additional testimony as to the significance of the conduct that resulted in the proffered exhibits." Bittner specifically requested more "evidence comparing the significance of various types of FDA sanctions, the frequency with which such sanctions are imposed, and the egregiousness of the conduct that prompts them." The ALJ noted that Halsey has introduced into evidence a warning letter received by MD Pharmaceutical June 21 relating to its production of methylphenidate ("The Pink Sheet" July 19, T&G-9). "I conclude, in light of all the circumstances, that the most expeditious procedure to facilitate the reconsideration is to rescind the May 5, 1993 decision and to issue a new decision following the receipt of additional relevant evidence," Bittner wrote. Houba applied for DEA registration March 1, 1991. The company needs a DEA license and quota before it can begin producing drug for bioequivalence studies to support an ANDA. The attorneys for NM Pharmaceutical are Robert Angarola, Robert Dormer and Brian Pendleton of Hyman, Phelps & McNamara. Houba is being represented by Scott Bass, Anthony Young and Diane McEnroe of Piper & Marbury.
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