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Drug monograph bill passes House

ADA thanks legislators

January 09, 2019

By Jennifer Garvin

Washington — The same day the ADA sent a letter urging legislators to call for a floor vote on the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019, the legislation passed the House, 401-17.

In a Jan. 8 letter to Speaker of the House Nancy Pelosi, D-Calif., and Minority Leader Kevin McCarthy, R-Calif., ADA President Jeffrey M. Cole and Executive Director Kathleen T. O'Loughlin thanked the legislators for the bill, 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 bill would also provide an innovative pathway for federal safety and effectiveness regulations that can directly align and benefit the ADA Seal of Acceptance program.

"The monograph drug approval process is generally less expensive and more efficient than filing a new drug application. However, 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 that were brought to market after 1972," wrote Drs. Cole and O'Loughlin.

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 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," wrote Drs. Cole and O'Loughlin.

This legislation 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," the letter concluded.

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