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BARR CONJUGATED ESTROGENS SUIT VS. FDA SEEKS PUNITIVE DAMAGES "IN EXCESS" OF $3 MIL.; GENERIC MANUFACTURER MAINTAINS FDA PASSED INFORMATION TO AHP

Executive Summary

Barr is seeking "in excess of" $3 mil. in punitive damages and more than $30,000 in compensatory damages from the FDA in a lawsuit that alleges the agency supplied Wyeth-Ayerst with confidential information regarding the generic firm's conjugated estrogens ANDAs. The complaint was filed in Washington, D.C. Federal Court Nov. 23. In addition to naming the agency as a defendant, the complaint also names Commissioner Young and "John Doe," an unknown agency employee. The complaint alleges that confidential information in Barr's ANDAs supporting an AB rating for conjugated estrogens based on urinary excretion studies was passed on to Wyeth-Ayerst. Barr maintains that as a result of the information, Wyeth-Ayerst was able to successfully argue that blood level studies, instead of urinary excretion studies, should be required to prove bioequivalence of generic conjugated estrogens. "Throughout the ANDA process, despite Barr's refusal to waive its confidentiality rights, Wyeth-Ayerst routinely received the information necessary to attack Barr's application and to anticipate FDA action," the complaint states. Following a submission by Wyeth-Ayerst in February, FDA decided to accept only blood level studies as the basis for determining bioequivalence of conjugated estrogens. In the letter, Wyeth-Ayerst urged the agency to disregard its December 1986 guidance for determining in vivo bioequivalence through urinary excretion studies and to require a blood level methodology instead. Just several days earlier, the Division of Generic Drugs, in a Jan. 27 letter, had informed Barr that the firm's urinary excretion studies were acceptable and that its conjugated estrogen 2.5 mg tablet would be considered bioequivalent to the innovator product, Wyeth-Ayerst's Premarin, according to the Barr complaint. "Wyeth-Ayerst's critique came over 14 months after the guidance document had been issued. Both the timing and the content of Wyeth-Ayerst's submission indicate that it had learned of Barr's ANDAs and of their specific content long before and had received inside information that the Division of Bioequivalence would find Barr's bioequivalence study acceptable," the filing alleges. However, FDA notified Barr and Able in June that their ANDA applications had been denied ("The Pink Sheet" July 4, T&G-11). Barr noted in the complaint that earlier in June FDAers "directly responsible for initial approval of an ANDA, [had] again agreed that Barr's ANDAs deserved approval." The complaint also cites an incident in which Gary Hodgen, a scientific expert retained by Barr, wrote FDA in May in support of Barr's methodology for determining bioequivalence of conjugated estrogens. Within a week, Hodgen received a telephone call from a Wyeth-Ayerst employee "evidencing full knowledge of the contents of Dr. Hodgen's letter," the filing asserts. "Again, the extent of Wyeth-Ayerst's knowledge of details of Barr's ANDAs indicates that defendants wrongfully disclosed confidential information to Wyeth-Ayerst." Barr is seeking punitive damages on three counts: - - "for intentional interference with prospective economic advantage" - - "deprivation of due process" - - and "breach of the duty of confidentiality." Along with the damages requested, the complaint asks for declaratory and injunctive relief. FDA Fertility and Maternal Health Drugs Advisory Committee will consider whether urinary excretions studies are adequate to determine the bioequivalence of conjugated estrogens at its Jan. 5-6 meeting ("The Pink Sheet" Nov. 7, T&G-10).
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