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GAO CRITIQUE OF CONSTRAINTS ON FDA OTC DRUG INSPECTIONS

Executive Summary

GAO CRITIQUE OF CONSTRAINTS ON FDA OTC DRUG INSPECTIONS could add further ammunition to the growing arsenal of congressional support for an FDA enforcement bill. In a report on FDA's regulation of nonprescription drugs released Feb. 27, the General Accounting Office notes that manufacturers of both OTC and prescription drugs must maintain customer complaint files, equipment maintenance logs and other manufacturing records. However, FDA lacks statutory authority to inspect the records of OTC drug firms, apart from those records that are "on display at the time of the inspection or that are voluntarily provided by the manufacturer," GAO states. While drug manufacturers will "generally provide access to their records upon request," FDA's "lack of full access... denies the agency a critical source of information on the nature and scope of postmarketing problems associated with OTC drug products," the report asserts. Rep. Wyden (D-Ore.) requested the investigation a year ago on behalf of his Small Business Committee/Regulation subcommittee. Under the FDA enforcement bill (HR 3642) introduced in the House by Rep. Waxman (D-Calif.), the agency would have full access during inspections to all records and files of all drug manufacturers, Rx and OTC alike. GAO's finding that lack of access to OTC drug manufacturing records could pose a threat to assuring safety and effectiveness may give the bill's sponsors another piece of support in their effort to build an argument for legislation. Wyden is not a cosponsor of the House bill, but has been sympathetic to providing FDA with greater enforcement powers ("The Pink Sheet" Dec. 24, 1990, p. 3). Overall, the report does not break much new ground. The 15- page document touches only briefly on specific health hazards associated with OTC drugs, including widely reported reactions such as bleeding ulcers following long-term use of acetylsalicylic acid, kidney damage linked to long-term use of acetaminophen, and kidney damage and ulcers following use of ibuprofen over a long period of time. GAO also cites "several cases of nonfatal choking" associated with guar gum, used in some OTC diet and laxative products. FDA prohibited use of guar gum in OTC weight control products last year, as part of a final rule banning 111 ingredients from those products ("The Pink Sheet" Aug. 12, T&G- 11). Questions about another diet aid ingredient, phenylpropanolamine, prompted Wyden to request the GAO's wider look at all OTC products. Wyden has taken an active role in the safety debate about phenylpropanolamine and has held hearings on reports of adverse reactions to the ingredient and its abuse potential for anorexics and bulimics ("The Pink Sheet" Oct. 8, 1990, T&G-14). "As you know, I have expressed grave doubts regarding the safety and efficacy of some products now being marketed as over-the-counter drugs," Wyden said in a Feb. 21 letter to FDA Commissioner Kessler that accompanied a copy of the report. "While most OTCs generally deliver for the consumer, I think we can both agree that this sector has its share of questionable nostrums." Wyden also noted, however, that "I am encouraged that the FDA has begun a thorough examination of [phenylpropanolamine]." The agency held an open public hearing on the agent last May ("The Pink Sheet" May 13, 1991, p. 7). In addition to finding FDA's statutory authority inadequate for OTC drug inspections, the GAO report also asserts that the OTC monograph process has allowed some products to reach the market without demonstrating safety and effectiveness. Specifically, FDA has promulgated only 34 of the 71 proposed monographs, GAO says. In addition, "FDA has adopted a policy that extends the coverage of the monograph program to all OTC drugs that were marketed up to 1972. As a result of this extension, FDA has exempted an undetermined number of individual OTC drug products first marketed between 1962 and 1972 from the NDA requirement to show proof of their safety and effectiveness." GAO also questions the adequacy of FDA's postmarket surveillance of OTCs. "FDA does not require manufacturers of OTC monograph drugs to report adverse reactions experienced by their customers," the report states. "Additionally, FDA does not know, and is unable to determine, the number of OTC products currently being marketed in the United States." Responding to the study, the Nonprescription Drug Manufacturers Association challenged GAO's questions about the safety and effectiveness of OTC products. "All OTC drugs are well regulated by FDA; differently, perhaps, but certainly not less regulated than Rxs," NDMA said (emphasis NDMA's). "FDA's 20 year review of the safety of OTCs is the most massive single study in FDA history...As a result of the review, FDA probably knows more about the safety of OTCs than any other category of products it regulates."
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