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ADA asks Senate to help FDA modernize over-the-counter drug monographs

July 17, 2017

By Jennifer Garvin

Washington — The ADA is asking the Senate to enact policy that will modernize the Food and Drug Administration's 40 year-old system for regulating over-the-counter drug products.

In a July 17 letter to Majority Leader Mitch McConnell, R-Ky., and Minority Leader Charles Schumer, D-N.Y., the Association urged the legislators to help the FDA streamline its monograph development process to make it faster and easier for the agency to update or replace scientific regulation for OTC products.

Drug monographs specify the conditions and procedures that, if followed, allow new OTC drug products to be marketed without prior FDA approval. Examples include anticaries drug products, first-aid antibiotics and sunscreens.

The monographs stipulate the allowable formulations and concentrations of active ingredients and include predetermined requirements for laboratory testing, package sizing, labeling and more. These monographs help free the FDA from having to review every new OTC drug product the agency would ordinarily consider safe and effective and correctly branded.

"Unfortunately, the laborious administrative process for updating OTC monographs is leading to obsolete testing for safety, quality and efficacy," wrote ADA President Gary L. Roberts and Executive Director Kathleen T. O'Loughlin. "Under the current regulatory scheme, FDA must go through a three-phase public rulemaking process to revise an OTC monograph. The process can take years (and sometimes decades) to resolve."

Drs. Roberts and O'Loughlin shared an example of how the lengthy process has affected dentistry, noting that the OTC monograph for anticaries drug products has not been updated since 1995 despite the fact that newer and better evaluation tests are available (e.g., one minute fluoride release test in fresh and aged samples). The FDA monograph, however, requires that these products still be evaluated using decades old tests that are outdated (e.g., caries reduction studies in animals).

"Streamlining the FDA's monograph development process would make it faster and easier to replace outdated product testing requirements with more modern scientific tests and methodologies," Drs. Roberts and O'Loughlin wrote. "It would also build confidence that new OTC drug products have met the latest and best available scientific standards for safety, identity, strength, quality and purity."

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