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Executive Summary

ANDA policy decisions involving versions of Marion's Carafate (sucralfate), SK&F's Dyazide and Lederle/Mylan's Maxzide (hydrochlorothiazide with triamterene), and Ayerst's Premarin (conjugated estrogens) are one area of interest for the House Commerce/Oversight Subcommittee's investigation into FDA's generic drug approval process. In an attachment to a March 14 letter, Chairman Dingell (D-Mich.) and Ranking Minority Member Bliley (R-Va.) asked HHS Secretary Sullivan to set up interviews between subcommittee staff and "any individuals . . . who were involved in substantive discussions within the agency or important contacts outside the agency regarding the agency policy toward the approval or disapproval of generic competitors for new indications for the innovator products for" Carafate, Dyazide, Maxzide and Premarin. The four compounds were the subject of ANDA disputes; they involve lucrative markets and pose tricky bioequivalence problems. For example, American Therapeutics was the first generic firm to receive marketing approval for a generic version of Maxzide even though a competitor, Vitarine, was awarded a six-month exclusivity period for being the first to submit an ANDA with a certification that its product did not infringe Mylan's Maxzide patent. Sponsors of ANDAs for generic versions of Carafate must conduct clinical trials rather than blood tests, FDA has ruled, because the compound works by protecting ulcers topically. The agency recently decided that firms seeking marketing approval for conjugated estrogens must carry out expensive blood level studies rather than the urine excretion analyses previously required. When facing criteria other than routine bioequivalence standards, several sponsors have alleged that FDA has been inconsistent in setting requirements. The subcommittee announced March 15 that it is expanding the scope of its investigation into FDA's system for generic drug reviews ("The Pink Sheet" March 20, p. 3). Dingell's subcommittee is examining several other compounds reviewed by the Generic Drug Division (see chart). The letter added that "a listing of all reviewers from either the ]Generic Drug Division[ or the Bioequivalence Review Division] responsible for each ANDA" should be included in the documentation. The subcommittee also requested "compliance profiles and AF jackets with data from Oct. 1, 1984 for all companies listed below: American Therapeutics; Pharmaceutical Basics/My-K Labs; Par Pharmaceuticals/Quad; Quantum; Biopharmaceutics/Integrated Genetics; Able Labs." The investigation is reviewing documentation regarding situations in which "any official or employee of the FDA or HHS has encouraged the development of the pharmaceutical or pharmaceutical chemical industries in India or any other country where product patent protection for pharmaceuticals is either nonexistent or appreciably substandard." Reports of travel to India by FDA and HHS employees were also requested. An attachment to the letter shows that 64 FDAers have been targeted for interviews by the subcommittee, reflecting the very wide net the subcommittee is casting in its broad investigation of the generics approval process. The potential for disruption of FDA activities is great. The list includes most of the FDA topside, including Commissioner Young; former Deputy Commissioner John Norris; Associate Commissioner for Legislative Affairs Hugh Cannon; Associate Commissioner for Regulatory Affairs John Taylor; Chief Counsel Thomas Scarlett; Drug Evaluation and Research Center Director Carl Peck; Office of Drug Evaluation I Director Robert Temple; Drug Standards Office Director Peter Rheinstein; Generic Drugs Division Director Marvin Seife; and the directors of the Gastrointestinal, Metabolism & Endocrine, and Cardio-Renal Drug Products Divisions. The subcommittee has emphasized the information-gathering nature of the interviews being scheduled. The vast majority of FDA personnel to be questioned are not suspected of being involved in improprieties. A numerical breakdown indicates that FDA staffers to be interviewed by the subcommittee include four from the Office of General Counsel, four from the Commissioner's Office, six from the Drug Evaluation and Research Center, 24 from the Generic Drugs Division, 16 from the Bioequivalence Review Division, and 10 miscellaneous agency employees. The subcommittee also requested interviews with nine former FDA chemists from the Genetic and Bioequivalence Divisions. Chart omitted.

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