Over-the-counter (OTC) medicines, other than those approved by direct application, are marketed under regulations referred to as “OTC monographs” and have been established through the U.S. Food and Drug Administration’s (FDA’s) OTC Drug Review. Following notice-and-comment rulemaking procedures pursuant to the Administrative Procedure Act, FDA initiated the OTC Drug Review in 1972 to evaluate approximately 800 active ingredients then in use.
As part of that exhaustive review, FDA chose to ban over 500 compounds from the market, and ultimately determined that only 270 or so active ingredients were generally recognized as both safe and effective (GRAS/E) for their intended uses. FDA also has issued “negative monographs” which prohibit the use of hundreds of specific indications for OTC drug ingredients. FDA continues to evaluate safety and effectiveness of OTC medicines, as warranted, through notice-and-comment rulemakings.
The Non-Prescription Drug Modernization Act of 2007 (H.R. 4083/S. 2311), introduced by Representative Henry Waxman (D-Calif.) and Senator Edward Kennedy (D-Mass.) in October 2007, seeks to overturn the judicious notice-and-comment rulemaking process mandated by the Federal Administrative Procedures Act. The Non-Prescription Drug Modernization Act (NPDMA) would allow FDA to immediately restrict the marketing of an OTC drug based solely on an internal finding that a drug poses a “significant risk” or “lacks evidence of effectiveness.”
FDA, however, already has authority to act quickly when necessary to protect the public from imminent harm. Section 553(b) of the APA provides for an exception to notice and comment requirements “when the agency for good cause finds . . . that notice and public procedure . . . are impracticable, unnecessary, or contrary to the public interest.” Under this authority, FDA can issue a direct final rule to require immediate changes in drug labeling and marketing.
Where imminent safety is not a concern, FDA has used traditional notice-and-comment rulemaking to collect additional data and revise OTC regulations accordingly. This robust regulatory process allows interested parties to conduct new research, submit new information, and inform FDA’s decision-making in a transparent policymaking process that accommodates the evolution of science.
The NPDMA’s provision allowing FDA to amend or repeal an OTC drug monograph based solely on an internal agency finding of “significant risk” or “lacks evidence of effectiveness” is too broad, fails to define what criteria and standards FDA would employ in making such findings, and would allow the agency to make final but premature decisions on the basis of limited data. In the absence of imminent safety concerns, OTC medicines already determined by FDA to be safe and effective should remain on the market while FDA conducts proper notice-and-comment rulemaking for those that need additional review. Consumers would be ill-served if incomplete or inconclusive data drive hasty decisions to remove safe and effective medicines from the marketplace.
FDA rules, whenever possible, should be developed in open, public proceedings. All interested persons should be afforded an opportunity to comment in order to ensure that decisions are based on the best available information. Under current notice-and-comment rulemaking, interested parties and the general public have shared data effectively with FDA prior to agency action.
Related Links: