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House approves streamlining approval for some OTC drugs

July 17, 2018

By Michelle Manchir

Washington — On the same day that the ADA sent U.S. House leaders a letter of support for legislation that would hasten the approval process for some over-the-counter drugs, the House passed the bill.

HR 5333, the Over-the-Counter Monograph, Safety, Innovation, and Reform Act of 2018 gained approval by the House July 16.

ADA President Joseph P. Crowley and Executive Director Kathleen T. O'Loughlin expressed the ADA's support for the measure in a July 16 letter to House Speaker Paul Ryan, R-Wis., and Nancy Pelosi, D-Calif., calling it "an important step towards alleviating the scourge of opioid abuse that has been devastating our families and communities."

The bill, which now goes to the Senate for consideration, would empower the Food and Drug Administration Commissioner to approve a drug submission by administrative order, bypassing a sometimes decades-long rulemaking process.

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 more active ingredients, which is particularly important the context of preventing opioid abuse."

Pointing out that 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 that the bill would establish "a pathway 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," Drs. Crowley and O'Loughlin wrote.

The bill would benefit dental patients by "allowing for more innovation in oral care," said Dr. Marcelo Araujo, ADA Science Institute vice-president. The measure may make more oral health care products eligible for consideration for the ADA Seal of Acceptance program. Products accepted into the program demonstrate safety and efficacy according to requirements developed by the ADA Council on Scientific Affairs.

The legislation received support from other health advocacy groups, including the American Academy of Pediatrics and the American Public Health Association.

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