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ADA asks FDA to update OTC process

August 02, 2017

By Jennifer Garvin

Washington — The ADA is asking the Food and Drug Administration to begin the public rulemaking process for updating several over-the-counter oral health drug products.

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.

In an Aug. 2 letter to FDA Commissioner Scott Gottlieb, M.D., the ADA asked the agency to begin the process for updating the following OTC oral health drug products:

  • Anticaries drug products
  • Oral health care drug products
  • Oral wound healing drug products
  • Nail-biting and thumbsucking drug products
The Association also requested that the FDA revisit the drug monograph for OTC pain relievers that can sometimes be used in lieu of opioid analgesics to manage post-operative dental pain.

“Many of the oral health-related OTC drug monographs have not kept pace with latest science-based testing standards,” wrote the ADA in a letter to FDA. “As a result, consumers are buying a new generation of OTC oral health products whose safety, identity, strength, quality, and purity are based on decades old science.”

The letter, which was written by Dr. Gary L. Roberts, ADA president; Dr. Kathleen O’Loughlin, ADA executive director, Dr. Jeffrey A. Platt, chair, ADA Council on Scientific Affairs, and Dr. Marcelo Araujo, vice president, ADA Science Institute also encouraged the FDA to consider the ADA Seal of Acceptance program as a resource for updating its process since dentists and consumers recognize the ADA Seal as the gold standard for testing and rating the quality of dental products.

“We would all benefit from knowing that the oral health-related drug products sold OTC have met the latest and best available scientific standards for safety, identity, strength, quality, and purity. Updating these drug monographs would be an important step in that direction,” the letter concluded.

In a July 17 letter to Majority Leader Mitch McConnell, R-Ky., and Minority Leader Charles Schumer, D-N.Y., the Association urged the Senate 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.

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Editor’s note: The ADA submitted a reformatted petition dated Aug. 4 to comport with FDA guidelines for citizen petitions.