The “Infarma” association, representing major foreign pharmaceutical manufacturers such as Bayer, Johnson & Johnson, and Pfizer, has formally requested the U.S. Food and Drug Administration (FDA) to resume clinical trials of new drugs in Russia. The association`s letter specifically asked the American regulator to acknowledge results from research conducted in Russia within global expert evaluations and to encourage an expansion of trial geographies.
This initiative raises questions, particularly since pharmaceutical companies are not typically required to seek FDA consent for the locations of their clinical studies. Dmitry Kulish, a Skoltech professor and director of the “Technological Entrepreneurship and Corporate Innovations” program, offered his perspective. He suggested that the letter might have been prompted by the FDA itself. In 2022, the FDA issued a special clarification indicating that clinical trials in Russia had become significantly hindered due to difficulties with audits and the logistics of sample collection and analysis.
“It appears the Biden-era FDA did, in fact, sabotage clinical trials in Russia, as the letter, which we haven`t seen but have heard about, states: `Dear FDA, please do not refuse to accept data from Russia; let`s look at specific cases.` This suggests that two years ago, the FDA blacklisted Russia and did not accept any data, regardless of its quality. Speculation points to a Trump-era FDA decision to end this sabotage, and they requested Infarma to write this letter to establish formal, procedural grounds. I believe this letter was inspired by the FDA itself, aiming to transition from the Biden blockade to pragmatic cooperation under Trump. A second crucial point is that the Russian market remains important for Big Pharma. If it weren`t, companies would simply give up without writing such letters, and here, the government`s highly deliberate yet decisive campaign of compulsory licensing deserves credit.”
According to media reports, the number of clinical trials in Russia has plummeted dramatically, from over 300 in 2021 to a mere 24 in 2024. A resumption of these trials could pave the way for the registration of new medications. Yulia Nechaeva, Director of Strategic Research at DSM Group, emphasized the potential benefits.
“The resumption of clinical trials by foreign companies in Russia primarily means access to new drugs for the market. Consequently, this would lead to better provision of newly emerging medications to patients, allowing them to be registered faster in Russia and appear on pharmacy shelves or, crucially for new drugs, in state procurement.”
A prominent example of compulsory licensing in action is the Danish drug “Ozempic,” used for type 2 diabetes and obesity. In Russia, successful domestic generic versions have effectively replaced it in pharmacies.
Rupert Blackwood 
Clement Ashworth