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Woodcock: High Prices Create Problems For Entire Accelerated Approval Program

 
• By Sarah Karlin-Smith

Acting FDA commissioner suggests a primary reason for outrage over accelerated approvals is the high costs of certain medications despite their unproven clinical benefits, an issue that is outside of the agency’s purview. Health policy experts says FDA shouldn’t be left off the hook that easily.

price tag
High price tags are leading to opposition to FDA’s accelerated approval program, Woodcock says • Source: Alamy

“Much of the debate,” around the US Food and Drug Administration’s accelerated approval program is not driven by the questions surrounding treatments’ risks and benefits but is instead spurred by “the larger societal trade off of the high prices for these agents,” FDA Acting Commissioner Janet Woodcock said in response to complaints around accelerated approval and whether she believes the program is ripe for reform or working as intended.

“Those perceived price tags don't just raise eyebrows, they create opposition to the entire program,” Woodcock said in a late November interview for the Biopharma Virtual Congress run by Prevision...

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