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ADA urges Senate to vote on updating FDA drug monograph

November 28, 2018

By Jennifer Garvin

Washington — The ADA is asking Senate leaders to call for a floor vote on 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 and open a pathway for products with two active ingredients.

In a Nov. 15 letter to Senate Majority Leader Mitch McConnell, R-Ky., and Minority Leader Chuck Schumer, D-N.Y., the ADA urged the Senate to pass the legislation, which would authorize the FDA commissioner to update a drug monograph by administrative order instead of following a laborious rulemaking process. The Association also expressed interest in the development of acetaminophen-ibuprofen products for treating postoperative pain in lieu of opioids.

Companies currently bring new over-the-counter drugs — also called OTC drugs — to market by going through either a new drug application process or adhering to a drug monograph. A drug monograph is a predetermined checklist covering active ingredients, doses, formulations and product labeling that the agency considers generally safe and effective for self use.

The OTC monograph drug approval process is generally less expensive and more efficient than filing a new drug application. However, OTC monograph drugs are limited to only one active ingredient per product and it can take years and in some cases, decades, to review and update a drug monograph to account for more modern methods of scientific testing and ingredients and formulations that were brought to market after 1972.

According to the letter from the ADA, "streamlining the approval process will, among other things, allow for the submission of nonnarcotic pain relievers with a combination of two or more active ingredients, which is particularly important in the context of preventing opioid abuse." The bill would also provide a pathway for federal safety and effectiveness standards to more closely resemble those for the ADA Seal of Acceptance program.

Pointing out that dental patients are often advised to treat postoperative pain with acetaminophen and ibuprofen in lieu of a prescription pain medication, ADA President Jeffrey M. Cole and ADA Executive Director Kathleen T. O'Loughlin said that the bill would establish "a pathway for a strength-controlled acetaminophen-ibuprofen combination drug to be considered for approval to be sold OTC. These types of combination drugs would be a safe, effective and convenient alternative to opioid pain relievers, which could be easily available.

"S. 2315 will improve the safety and effectiveness of over-the-counter drugs and foster innovation in the development of new pain medications. We urge you to bring this bill to the floor so that it may be considered by the full Senate," Drs. Cole and O'Loughlin concluded.

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