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FDA "ORANGE BOOK": ANDA INSPECTION DATES, RESULTS

Executive Summary

FDA "ORANGE BOOK": ANDA INSPECTION DATES, RESULTS should be included as a regular feature of the FDA's list of Approved Drug Products with Therapeutic Equivalence Evaluations, the Pharmaceutical Manufacturers Association said in Oct. 18 comments on improving the Orange Book. The PMA recommended that "a summary of any ANDA pre-approval inspection conducted should be included in the monthly update to the Orange Book and the dates of inspections conducted during the past year should be included in the annual revised edition." The association also recommended that a "summary basis for approval of multiple source drugs should be available which would describe the nature of the study data submitted, when the study was submitted and where it was conducted." PMA maintained that the Orange Book's current format forces health practitioners to make several potentially false assumptions about the products listed, and suggested several changes in format. The current format includes three categories of drugs: 1) 1938-1962 drugs with known bioavailability problems. For these and post-1962 drugs, FDA requires submission of a bioavailability/bioequivalence study, except in specific circumstances; 2) Other 1938-1962 drugs, assumed to be bioequivalent; and 3) pre-1938 drugs, which have no requirements, except for digoxin. "The three classes of drugs and exceptions . . . are not clearly identified in the Orange Book and consequently the book does not provide adequate information on which to make an informed judgment," PMA stated. "In some respects it seems designed to mislead practitioners," the association added. Practitioners must assume that the listed products are "adequately labeled," that the products meet "applicable compendial standards" and that they "are manufactured in compliance with current good manufacturing practices." In addition, according to PMA, practitioners are forced to make assumptions about the interchangeability of products with no bioequivalence testing, the safety of B-rated drugs, the scientific validity of quoted bioequivalence tests, the role of the 20% plus or minus rule and that the FDA method of determining bioequivalency has been "scientifically validated so as to permit indiscriminate switching of drug products (pioneer to generic, generic to generic)." PMA maintains that "the above assumptions are not always valid." To improve the guide book, PMA recommends that drugs and their dosage forms be recorded under three separate categories and that testing requirements be identified through a new coding system. Under this system, numerical codes would be used to divide drugs into seven distinct classes: pre-1938 drugs with no test requirements, pre-1938 drugs with bioavailability/bioequivalence studies submitted, drugs for which only in vitro dissolution tests were submitted, drugs in which in vitro bio studies were submitted, drugs for which in vitro studies were waived, drugs for which bioequivalency is assumed in the absence of any contrary information, and drugs for which full NDAs, including safety and efficacy studies, had been submitted. Additional codes were recommended by PMA to denote products which should not be substituted or switched indiscriminately and to underscore any exclusive indications a product might have. PMA further suggested a new coding system which would identify the type of testing each product had undergone and which tests remained to be submitted before the product could receive federal approval. In separate comments filed Oct. 18, Connaught Labs recommended that vaccines and treatment biologicals be added to the publication. Connaught pointed to the growing number of new multi-source vaccines and biologicals, including its own haemophilus influenza type b conjugate vaccine, ProHIBIT, and two other HIB conjugate vaccines. "Inclusion of these products within the Orange Book would serve two important purposes," the company said: physicians would be able to ascertain readily whether a vaccine, a therapeutic or a treatment biological has been approved or licensed; and reimbursement by Medicare and Medicaid for such products would be "streamlined" since "most state formularies make an initial determination of reimbursement eligibility for both Medicaid and third party reimbursement on the basis of the Orange Book."
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