Former FDAer Wants Freeze on Russian Applications

Former FDA director of orphan product development Timothy Cote is petitioning the agency to “immediately and completely freeze all administrative actions on any regulatory requests from pharmaceutical and medical device companies headquartered in Russia or with majority Russian ownership.” His 2/22 emergency petition cites the Russian invasion of Ukraine as the reason for the agency to freeze its regulatory actions.

Cote says he is well aware that there are many Russian pharmaceutical/biotech companies with applications being reviewed by CDER, CBER, CDRH, and the Office of Orphan Product Development.

“Continuing the advancement of these applications through the FDA regulatory process would allow Russian companies access to the U.S. market that they currently do not have,” Cote writes. “This would be antithetical to the premise that Russia must pay economic consequences for invading its neighbors.”