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Senate passes drug monograph legislation

Bill could create pathway for single strength-controlled acetaminophen-ibuprofen combination drug

December 12, 2019

By Jennifer Garvin

Washington — The Senate Dec. 10 voted 91-2 in favor of the Over-the-Counter Monograph Safety, Innovation and Reform Act — legislation that would reform the Food and Drug Administration's system for regulating over-the-counter drugs.

The bill, S 2740, returns to the House for consideration, where it previously passed, 401-17, as part of a larger bill in January 2019. The bill authorizes the FDA commissioner to update a drug monograph by administrative order instead of following a laborious rulemaking process. A drug monograph is a predetermined checklist covering acceptable ingredients, formulations, testing methods, packaging, labeling and more.

Updating the drug monograph has been a key ADA priority for the last two Congresses. The Association hopes that reforming the over-the-counter process would help create a pathway for a single strength-controlled acetaminophen-ibuprofen combination drug to be developed, which could become a viable alternative to opioid pain relievers. The ADA also believes it will bring major benefits for the oral health products, as it will allow for combination of important ingredients used to prevent oral diseases.

In a Dec. 12 letter to Speaker of the House Nancy Pelosi, D-Calif., and Minority Leader Kevin McCarthy, R-Calif., the ADA urged lawmakers to bring the bill to the floor. ADA President Chad P. Gehani and Executive Director Kathleen T. O’Loughlin said that under current law, drug products with ingredients that the FDA generally recognizes as safe and effective for self-use “may bypass the rigorous and expensive new drug application process if they are tested, manufactured, labeled and reviewed in accordance with an appropriate drug monograph.”

This process is generally less expensive and more efficient than filing a new drug application but as the ADA pointed out, “it can take years and in some cases decades to review and update a monograph to account for ingredients, formulations and methods of scientific testing than were available in 1972.” Passing the Over-the-Counter Monograph Safety, Innovation and Reform Act of 2019 would enable the FDA to implement a “much more nimble and far more effective” approval process, the ADA stated in the letter.

For more information on the ADA’s advocacy efforts, visit