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# FDA Denies Petition Seeking Freeze on Russia-based Applications
- URL: https://www.fdaweb.com/fda-denies-petition-seeking-freeze-on-russia-based-applications/
- Published: 2022-08-24T12:00:00.000Z
- Updated: 2026-09-14T17:57:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152581

FDA has denied a citizen petition seeking a “freeze” on all regulatory requests from pharmaceutical and medical device companies headquartered in Russia or with majority Russian ownership due to the country’s invasion of, and war against, Ukraine. The February petition was filed by former FDA Office of Orphan Product Development director **Timothy R. Cote**, who is CEO of consulting firm Only Orphans Cote.

The petition said that allowing pending applications to continue through normal regulatory processes “would allow Russian companies access to the U.S. market that they currently do not have. This would be antithetical to the premise that Russia must pay economic consequences for invading its neighbors.”

In denying the petition, [FDA said](https://downloads.regulations.gov/FDA-2022-P-0237-0003/attachment%5F1.pdf?ref=fdaweb.com) its legal authorities do not “direct it to consider the country where a pharmaceutical or medical device company is headquartered when we decide whether to take action on a regulatory request from that company. We are also not directed to consider the citizenship of a company’s owners.

“We have deep concern,” the agency continued, “for the health and safety of the Ukrainian people during the ongoing Russian invasion of Ukraine and FDA stands with the people of Ukraine as they bravely defend  
their country.”