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SOLID DOSE IMPRINT REGULATION EXPECTED "FAIRLY SOON" FROM FDA

This article was originally published in The Tan Sheet

Executive Summary

SOLID DOSE IMPRINT REGULATION EXPECTED "FAIRLY SOON" FROM FDA, the Nonprescription Drug Manufacturers Association said. Despite the delay on pending regulations caused by the change in administrations, NDMA believes FDA will be able to publish the final proposal after a four-year effort by NDMA to standardize imprinting requirements on a national basis. NDMA President James Cope told a March 5 general session of the association's annual meeting that "while we understand there is no policy problem with [the proposed reg], understandably the new Clinton Administration wants to take a look at all regulations that have not yet hit the Federal Register." NDMA originally went to FDA seeking a uniform imprint requirement in May 1989 after Washington State had set its own requirements. An FDA proposed reg was published in May 1991. The association is also asking FDA for help in the adverse drug reporting area. Following congressional interest in that subject during the last two years, NDMA has been working with FDA to get a regulation written that would establish a system of adverse event reporting "similar to that in place for those prescription drugs which are not subject to NDA requirements." NDMA believes that such a system would be less burdensome than a potentially legislated approach. "We went to FDA with a proposal late last summer," Cope reported, "and have asked them to issue a regulation to this effect, as it really is not a matter well handled by a voluntary program." Indicating that the regulatory process on this proposal has not progressed far beyond NDMA's proposal, Cope said: "We're awaiting further word from the agency." NDMA continues to worry about piecemeal regulation by the states. In addition to the imprint situation, the association reports that through the first two months of 1993, 15 bills to regulate OTC medications at the statewide level have been introduced in state legislatures. NDMA Senior VP-General Counsel Daniel O'Keefe observed that one of the newly introduced measures in New York would require special OTC label warnings for the elderly and another in Texas would mandate the inclusion of bittering agents in topical OTCs. For the past several years, NDMA has hoped to have the concept of national uniformity adopted in federal legislation. However, that has proven a difficult proposal coming up against opposition from states' rights supporters and advocates of strong, activist attorneys general. Freshman Senator Robert Bennett (R-Utah) was asked at the end of a speech to the March 5 general session about his opinion on national uniformity. "I may not have been in Washington very long," Bennett artfully replied, "but I have been in Washington long enough to learn that the first cardinal rule is you don't commit until you have to." Two years ago, NDMA had more success, getting House Energy and Commerce Committee Chairman John Dingell (D-Mich.) to acknowledge at a previous annual meeting that national uniformity might be a logical component of an FDA enforcement bill extending the agency's regulatory powers. The legislative impetus for that bill, however, has faded on Capitol Hill as FDA under Commissioner Kessler has developed an image of a more effective enforcement agency and cost issues have moved to the front of the health care debate -- particularly concerning FDA-regulated products such as pharmaceuticals. NDMA recently has presented its position on national uniformity to Congress and new members of the Clinton Administration in the form of a briefing book. "What is needed is for the federal government to state the obvious: FDA occupies the field of OTC drug regulation and any state law or regulation that differs from the federal standard is preempted," NDMA stated in the booklet. Referring to state legislative and regulatory initiatives such as California's Prop. 65 and Washington State's recent tamper- resistant packaging proposal, NDMA asserted that "the OTC industry cannot effectively fulfill its role in the nation's health care system if it must contend with the inconsistent actions of 50 'mini-FDAs.'" State regulation of OTC drugs, according to the briefing book, would create a "confusing, duplicative system of regulations" that would "not bring consumers additional health benefits." However, NDMA suggested that any federal preemption provision should be flexible enough to allow states "to take action" when "justified by compelling local conditions," and if it "does not interfere with interstate commerce." At the urging of NDMA, the Edwards Committee's 1991 report on FDA contained a recommendation that Congress enact legislation preempting additional conflicting and state requirements for FDA- regulated products. At the time, NDMA suggested that uniformity should be achieved through "administrative actions" rather than waiting for Congress to enact legislation.
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