ADA urges Senate panel to help speed drug application process

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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