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ADA urges Senate to advance drug monograph reform legislation

October 31, 2019

By Jennifer Garvin

Washington — The ADA is asking the Senate Committee on Health, Education, Labor and Pensions to pass the Over-the-Counter Drug Safety, Innovation and Reform Act — legislation that would reform the Food and Drug Administration's system for regulating over-the-counter drugs.

In an Oct. 30 letter to Committee Chair Lamar Alexander, R-Tenn., and Ranking Member Patty Murray, D-Wash., the ADA urged the committee to support S 2740, which would authorize the FDA commissioner to update a drug monograph by administrative order instead of following a laborious rulemaking process.

In the letter, 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.” A drug monograph is a predetermined checklist covering acceptable ingredients, formulations, testing methods, packaging, labeling and more.

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.”

The Association also said that drug monograph reform would establish a pathway for a “single strength-controlled acetaminophen-ibuprofen combination drug” to be developed and made available over-the-counter. These types of combination drugs, which are already used in some countries, can be “safe, effective and easily accessible alternatives” to opioid pain relievers.

“For example, dental patients are often advised to treat postoperative pain with a combination of acetaminophen and ibuprofen in lieu of a prescription pain medication,” wrote Drs. Gehani and O’Loughlin. “The current regulatory scheme prohibits these active ingredients from being combined into one pill/tablet, meaning patients have to buy them separately and take different numbers of different pills at different times of day. In the wrong combinations, these medications could be harmful even though they are generally considered safe.”

Passing the Over-the-Counter Drug Safety, Innovation, and Reform Act of 2019 would enable the FDA to implement a “much more nimble and far more effective” approval process, said Drs. Gehani and O’Loughlin. They emphasized that the FDA would still have to supply a detailed justification for issuing the administrative order to update the monograph and the order itself would be subject to 45 days of public comment and a reasonable period of judicial review, if requested.

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