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GENERIC BIOEQUIVALENCE REGULATIONS IN LIEU OF GUIDELINES

Executive Summary

GENERIC BIOEQUIVALENCE REGULATIONS IN LIEU OF GUIDELINES are requested by seven physicians in a Dec. 12 petition to FDA. The physicians, represented by the D.C. law firm Sonnenreich & Roccograndi, request FDA to revoke all presently existing bioequivalence guidelines, propose regulations establishing procedures for determining specific bioequivalence criteria for specific drugs, and promulgate new bioequivalence requirements in the form of proposed regulations. Maintaining that the 18 existing bioequivalence guidelines are inconsistent in length and thoroughness, the petitioners state that regulations could "establish a standard format. They could require study designs and recommended subject selection strategies. They could mandate the inclusion of scientific literature citations." The physicians' group maintains that the guidelines for propranolol distinguish between single dose and multiple dose studies, recommend study designs and a strategy for subject selection, and discuss matters of treatments, assay and results. In contrast, the physicians assert, guidelines for phentermine HCl "contain only four sentences in a single paragraph." The petition also requests that new regulations be applied retroactively. The petitioners ask FDA "to require sponsors of all ANDAs previously approved under the existing guidelines to submit, in those cases where bioequivalence requirements have been revised, new bioequivalence data for review and approval pursuant to final regulations." The physicians contend that "the current bioequivalence guidelines were not proposed and published as regulations, and thus consumers, the medical and scientific community and the public at large were all deprived of the opportunity to comment and provide meaningful scientific input." They argue that the guidelines do not meet the exceptions to the proposed rulemaking requirement of the Administrative Procedure Act since the guidelines are substantive, rather than interpretive rules "that establish specific criteria for the approval of pharmaceutical products." Michael Sonnenreich, one of the attorneys representing the seven physicians, is also chief counsel for Medicine in the Public Interest (MIPI). In June, MIPI filed a Freedom of Information request asking FDA for copies of data used to establish criteria for bioequivalence guidelines ("The Pink Sheet" June 24, T&G-3). Sonnenreich was also involved in the effort to block oral anti-diabetic labeling for the Cmte. for the Care of Diabetics in the early 1970s. The seven physicians who filed the petition are: Henry Dolger, MD, Mt. Sinai Medical School; Richard Gubner, MD, Clearwater, Fla.; James Ketchum, MD, and J. Thomas Ungerleider, MD, UCLA Neurophychiatric Institute; Robert Millman, MD, Cornell University Medical School; John Morgan, MD, CUNY Medical School, NY; and Sidney Schnoll, MD, Northwestern University Medical School.

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