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Executive Summary

OTC DRUG OFFICE SHOULD BE "LEAD OFFICE" FOR Rx-TO-OTC SWITCHES, the Nonprescription Drug Manufacturers Association maintained in Aug. 2 comments to the Edwards Committee, formally known as the Advisory Committee on FDA. In recommending the establishment of the Office of OTC Drugs, NDMA stated that the office should be given the responsibility to "serve as the lead office for consideration of all requests for Rx-to-OTC switches." The office's three other main responsibilities would be to facilitate completion of the OTC drug review and maintain a "dynamic OTC drug monograph system in the future," to provide "technical and policy backup" on OTC matters before FDA, and to serve as the main office for review and approval of all NDAs and supplemental NDAs for OTC drugs. NDMA's comments were submitted in response to a July 3 Federal Register notice calling for public comments on FDA's future role. The association said that raising the OTC Drug Division to the office level within the agency would signal an increase in priority given by FDA to OTC issues. The association has also requested clearance to testify at the Sept. 27-28 meeting of the subcommittee on drugs and biologics. The group plans to ask for permission to testify at the next full committee meeting in December. The association contended that the cost of setting up such an OTC office "would not substantially add to the overall budget of the FDA, which is approximately $600 mil. with about 2,200 FTEs [full-time equivalents] -- 700 devoted to new drug evaluation and almost 400 to generic drug evaluation." NDMA suggested that the office could consist of a director, a deputy director, with two full-time medical reviewers and support staff. The group added that creation of this office would free reviewers from new drug evaluation offices from having to review clinical data on OTC products. NDMA also repeated its recommendation that an OTC Drugs Advisory Committee be appointed to support the Office of OTC Drugs. An advisory committee could aid the office in finishing the OTC drug review and in maintaining the OTC monographs, the association said. OTC drugs are "suffering from a form of regulatory neglect at the FDA," NDMA maintained, and establishment of an OTC office can give a "higher priority" to OTC products and issues within the agency. The association has been lobbying FDA to set up an Office of OTC Drugs and a standing OTC advisory committee since at least January 1986, when NDMA made its suggestions in a letter to FDA. A few months later, then-Commissioner Young told NDMA that an OTC advisory committee "was worth considering." The creation of an OTC drugs office is one of two recommendations that the association made to the Edwards Committee in its comments. NDMA also suggested that "a regulation should be adopted to preempt additional or conflicting state requirements" concerning the safety, efficacy, labeling or packaging of OTCs. The association said it believes FDA's regulatory role and health care provided through OTC use is being "undermined by the trend toward duplicative and conflicting state requirements governing drug products." An initiative for preemption should be flexible to allow "appropriate state-initiated proposals," the association added. NDMA's concerns about national regulatory uniformity were raised primarily by California's regulations stemming from the state's 1986 law on reproductive toxicity warnings, commonly known as Proposition 65.



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