Proposed FDA oversight bill would work in tandem with Inflation Reduction Act

Three members of the House of Representatives proposed legislation for new drugs to go through an independent value assessment to determine a fair price, which the lawmakers said would complement the recently passed Inflation Reduction Act

California Reps. Jackie Speier and Katie Porter and New York Rep. Jerry Nadler introduced the bill, titled the Independent Drug Value Assessment Act, Nov. 16. The proposed legislation calls for independent organizations, such as universities and nonprofits, to analyze new drugs and their projected costs. It also seeks to scrutinize prescription drugs that are in the top 35 percent of Medicare expenditures. 

"It ensures drugs previously granted fast-tracked approvals or whisked through the approval process as breakthrough therapies are subject to the scrutiny patients need and deserve," Ms. Speier said in a statement. 

From 2018 through 2021, delays in confirmatory trials for drugs in the FDA's accelerated approval program cost the U.S. more than $18 million, according to an HHS report

"Year after year, pharmaceutical companies get away with charging exorbitant prices for drugs without demonstrating the true value of these medicines for patients, jeopardizing the health and well-being of millions of Americans," Mr. Nadler said in a statement.

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