US FDA Denies Petition Seeking Freeze On Russian Companies’ Regulatory Activities
Agency tells former OOPD director Tim Coté it doesn't have the authority to consider sponsor’s country of origin when determining whether to act on applications. Despite the denial of petition, FDA continues to support Ukraine.
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Appropriators are “concerned by the fragility of the infant formula supply chain and the detrimental health impacts that can arise from shortage of these regulated products.” Their report published with FY2023 omnibus appropriations also asks for list of Russian firms with pending NDAs, including OTCs.
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.
PhRMA wants to ensure medicines remain available, as many smaller companies and other stakeholders call for ‘disengagement’ from Russia.