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HEHS-94-136R 1 (1994-05-06)

handle is hein.gao/gaobackod0001 and id is 1 raw text is: United States GAO General Accounting Office Washington, D.C. 20548 Human Resources Division B-256121 May 6, 1994 The Honorable John D. Dingell Chairman, Committee on Energy and Commerce House of Representatives The Honorable Orrin G. Hatch United States Senate Because of changes over the last few years in the Food and Drug Administration's (FDA) monitoring of generic drug manufacturers,' you were concerned about possible inconsistencies in FDA oversight that could lead to inequitable treatment of manufacturers. Specifically, you requested that we examine whether policies and procedures exist to ensure that FDA is reasonable in selecting manufacturers to inspect, in assessing manufacturers' compliance with good manufacturing practices (GMP),2 and in pursuing enforcement actions against manufacturers. In addition, you requested that we determine whether manufacturing firms know of FDA's standards for assessing compliance with GMPs. To ensure that manufacturers produce safe and effective products, FDA personnel apply and enforce GMPs requiring interpretation of FDA's policies and procedures. 'A generic drug is usually manufactured after an innovator or brand name drug's patent has expired and is generally a lower cost alternative to the brand name drug. Some manufacturers produce both types. FDA does not distinguish between manufacturers of generic drugs and innovator drugs in its inspection and enforcement actions. 2GMPs represent the minimum practices for methods, facilities, and controls to be used in manufacturing, processing, packing, or storing a drug. As an example, the Production and Process Controls GMP requires written procedures to assure that products have the identity, strength, quality, and purity that they are represented to possess, and that any deviation from the written procedures is recorded and justified. GAO/HEHS-94-136R FDA Drug Enforcement Actions

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