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ADA asks House to modernize OTC drug process

September 13, 2017

By Jennifer Garvin

Washington — The ADA is asking the House Committee on Energy and Commerce Subcommittee on Health to support legislation that will modernize the Food and Drug Administration's 40 year-old system for regulating over-the-counter drug products.
In a Sept. 13 letter to subcommittee Chair Michael C. Burgess, R-Texas, and Ranking Member Gene Green, D-Texas, the ADA urged the legislators to enact policy that will streamline the FDA's system as the committee looks at legislation to reauthorize the Prescription Drug User Fee Act.

The letter was sent ahead of a subcommittee hearing on ways to modernize the FDA's regulation of over-the-counter drugs.

Drug monographs free the FDA from having to review every new OTC drug product the agency would ordinarily consider safe and effective and correctly branded. They also specify the conditions and procedures that, if followed, allow new OTC drug products to be marketed without prior FDA approval.

"The current system involves a three-phase public rulemaking process that can take years — and sometimes decades — to resolve," wrote ADA President Gary L. Roberts and Executive Director Kathleen T. O'Loughlin, noting that this "laborious" process is leading to obsolete testing for safety, identity, strength, quality and purity.

Drs. Roberts and O'Loughlin pointed out that despite updated science the OTC monograph for anticaries drug products has not been updated since 1995.

"This means the safety and effectiveness of these products is being based on decades-old science when newer and better testing methods are available," Drs. Roberts and O'Loughlin wrote. "Consumers deserve to know that the oral health drug products they are buying comport with best available quality and safety standards."

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