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February 25, 2022

Ukraine: Former FDA-er calls for agency to freeze Russian regulatory requests

There are at least five pharma companies and two research centres headquartered in Russia with a clinical trial site recruiting in the US.

By Reynald Castañeda

Former FDA orphan drugs office director Tim Coté is set to file for a citizen petition today to the agency for it to immediately stop administrative work that relates to pharma companies headquartered or are predominantly owned by Russia.

“Since the major response of the US to the Russian invasion will be economic sanctions, I think it’s a terrible idea if the FDA would keep processing Russian entities’ pitches to enter the US market,” Coté tells Clinical Trials Arena. The world had its eyes on geopolitical news from yesterday as Russian troops crossed the border into Ukraine.

Despite the news coverage, Coté says applications from Russia are still likely to be active with the FDA. And while Russia is not necessarily a major player in the US market, the move would be in line with US President Joe Biden’s recent announcements noting a broad array of severe economic sanctions against Russia, he adds.

Former FDA orphan drugs office director Tim Coté

Yesterday, Clinical Trials Arena released an analysis detailing how many clinical trials are ongoing and planned in Ukraine, as well as what their therapy and disease space.

At least two assets have IND filed with FDA

According to GlobalData’s company database, there are at least five pharma companies and two research centres headquartered in Russia with a clinical trial site recruiting in the US. Further, there is at least one Russia-based pharma company (NPO Petrovax Pharm) and an academic institution (Saint Petersburg State University) with an IND filed to the FDA.

Coté notes there would be more companies affected if medical device companies are included. As per the petition seen by Clinical Trials Arena, there are likely to be applications under review at the FDA by the Center for Drugs Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiologic Health, and the Office of Orphan Products Development. 

The definition of what is a Russia-owned company would be something the FDA would have to decide upon, Coté notes. And so, there would likely be between one-to-two dozen pharma firms likely to be affected if the FDA acts, he adds. 

Citizen petition a longstanding channel

The FDA citizen petition process allows individuals or community organisations to make requests to the agency surrounding health policy. This is a well-established channel to communicate to the FDA and the agency is required by law to respond to these petitions, Coté notes.

At times, these petitions can get “stuck in the mud,” and replies can arrive after several months, he adds. But with Ukraine in the headlines, it would make it harder for the FDA to ignore the petition, he notes.

If the agency does impose sanctions to these companies, the decision to lift them should also go in line with the US administration’s decisions, he says. Coté is the former director of the FDA’s Office of Orphan Products Development but is now the CEO and consultant at Only Orphans Coté.

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