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Committee passes legislation calling for FDA to modernize drug monograph

May 09, 2018

By Jennifer Garvin

Washington — The House Committee on Energy and Commerce on May 9 passed H.R. 5333, the Over-the-Counter Monograph Safety, Innovation and Reform Act of 2018 — legislation that would modernize the Food and Drug Administration’s system for regulating OTC drugs.

In a May 8 letter to the committee, ADA President Joseph P. Crowley and Executive Director Kathleen T. O’Loughlin said the ADA supports the bill, noting the legislation is “an important step towards alleviating the scourge of opioid abuse that has been devastating our families and communities.” H.R. 5333 bill is a companion to the Senate version of the bill, S. 2315, which the ADA also supports.

“Dental patients are often advised to treat post-operative pain with acetaminophen and ibuprofen in lieu of a prescription pain medication,” Drs. Crowley and O’Loughlin wrote. “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.”
Companies currently bring new 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 acceptable ingredients, doses, formulations and product labeling.

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.

“Streamlining the approval process will, among other things, allow for the submission of non-narcotic pain relievers with a combination of two or more active ingredients, which is particularly important in the context of preventing opioid abuse,” Drs. Crowley and O’Loughlin noted.

The bill would allow the FDA Commissioner to approve monograph drug submissions by administrative order. The agency would have to supply a detailed justification for issuing the order, and the order itself would be subject to 45 days of public comment and a period of judicial review.

This approval process would be “much more nimble and far more effective than the one now in place,” wrote Drs. Crowley and O’Loughlin.
“We urge the Committee to issue a favorable report so it may be considered for a floor vote by the Senate,” they concluded.

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