Drugs From Sponsors ‘Located in Russia,’ Would Be Barred From US FDA Review By House Funding Bill

 
• By Sarah Karlin-Smith
  
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Language of the amendment cleared by appropriators in response to the Russian war against Ukraine in FDA’s fiscal year funding bill is vague, making impact of the funding ban on industry unclear. Democrats supported the amendment but said they wanted to continue to work on language to avoid “unintended consequences.” FDA would get a 10% bump in non-user fee funds under the bill.

US, Russia, Ukraine, chess pieces
Congressional appropriators take aim at Russian pharma business in FY 2023 FDA funding • Source: Shutterstock

The US Food and Drug Administration would be prohibited from reviewing or approving a drug or biologic application submitted “by a sponsor located in Russia,” unless the application is for a drug intended to treat a serious or life-threatening condition and for which there is an unmet medical treatment need, per an amendment tacked on to the House Committee on Appropriations fiscal year 2023 FDA fundingbill.

The amendment, sponsored by Rep. Ken Calvert, R-CA, was adopted by a voice vote 24 June; the overall bill cleared...

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