WASHINGTON — President Joe Biden Friday signed legislation that aims to lower prescription drug costs by getting generic drugs to market more quickly.
The Food and Drug Administration grants five years of manufacturing exclusivity to pharmaceutical companies for drugs determined to be a new chemical entity.
Sen. Roger Marshall’s legislation tightens the rules, requiring that drug products must include an active molecule not previously approved by the FDA to qualify for exclusivity.
It’s a change that the Kansas Republican and co-sponsors, Louisiana Republican Sen. Bill Cassidy and Minnesota Democratic Sen. Tina Smith, say will enable generic versions of drugs to be manufactured more quickly.
The bill is Marshall’s first piece of legislation signed into law since joining the Senate in January.
“As a physician, I believe innovation and competition can have a profound impact on driving down the cost of health care,” Marshall, an OB-GYN, said in a statement.
“The current regulatory landscape unnecessarily delays patient access to FDA-approved generics. I’m pleased my first bill as a U.S. Senator to be signed into law ensures affordable life-saving medicine while preserving innovation for cutting-edge medicine.”
The legislation passed the Senate by unanimous consent in February and passed the House by a voice vote this month.
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