ADA urges Senate panel to help speed drug application process

Clinical Leadership & Infection Control

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The American Dental Association urged the Senate Committee on Health, Education, Labor and Pensions to pass legislation that would change the FDA's regulation of over-the-counter drugs in an Oct. 30 letter. 

The letter — addressed to committee chair Lamar Alexander, R-Tenn., and ranking member Patty Murray, D-Wash. — asks the committee to support the Over-the-Counter Drug Safety, Innovation and Reform Act. The act would allow the FDA to update a drug monograph, a predetermined checklist used to regulate products, by administrative order instead of the current extensive rulemaking process.

Currently, if a drug product meet a monograph's requirements — including acceptable ingredients, testing methods, packing and more — it could "bypass the rigorous and expensive new drug application process," the ADA says.

A reform could also help develop an over-the-counter "single strength-controlled acetaminophen-ibuprofen combination drug," according to the ADA. This type of drug can be a "safe, effective and easily accessible" alternative to opioid pain relievers.

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