12.10.19

Alexander: Senate Passes “Most Important” New Law For Over-the-Counter Drugs in 40 Years

Says legislation will improve the safety, innovation, and affordability of drugs Americans buy without a prescription at the pharmacy

WASHINGTON, D.C., December 10, 2019 – Senate health committee Chairman Lamar Alexander (R-Tenn.) said the Senate today passed “the most important new law affecting the safety, innovation, and affordability of over-the-counter drugs since the 1970’s.” 

“In 2015, as the Senate health committee was working on the 21st Century Cures Act, I asked Janet Woodcock, the Director of the Center for Drug Evaluation and Research at the Food and Drug Administration, if there was any change she needed but hadn’t been able to get done,” Alexander said. “She replied that the over-the-counter monograph – the rules that govern how all drugs sold at pharmacies other than prescription drugs are approved – hadn’t been updated since the 1970’s and that she hadn’t been able to persuade Congress to do it.”

“Senator Isakson and Senator Casey’s Over-the-Counter Monograph Safety, Innovation, and Reform Act will now modernize those rules. It is a great testament to Senator Isakson’s legislative skill and determination, and I thank him and Senator Casey for their work to get this update across the finish line.”

The Senate health committee passed the Over-the-Counter Monograph Safety, Innovation, and Reform Act by voice vote on October 31, 2019.

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