No, FDA Did Not Stop Accepting Clinical Data from China, But…
(Thursday, February 17, 2022)
Last week after FDA persuaded its oncology drug advisory committee to soundly reject a new drug approval application due to it being based on clinical data exclusively from China, some may have been given the impression that FDA no longer accepts clinical data from China for market approval in the US. It is far from it. A review of the case from last week shows that FDA merely tried to stem a loophole in the bud whereby multiple Chinese companies were planning similar FDA approvals for new drugs based on clinical trials conducted exclusively in China. The US regulations allow clinical data from anywhere in the world so long as it meets FDA’s standards. Hence, almost all new market approval applications submitted to the FDA include significant amounts of non-US clinical data. According to the FDA, clinical data for 4 out of 5 approved drugs included non-US data and almost 9 out of 10 (87%) patients enrolled in FDA regulated trials are non-US volunteers. However, never did all the non-US data for a given market approval application come from one country. It came from “global multi-national” trials. The issue with the recent trend, that FDA rebuffed, was a business strategy developed by several Chinese companies. Under this strategy clinical studies would be conducted exclusively in China. These studies would target expensive drugs to create enough financial returns for the developers. These studies will be conducted outside of the US regulatory oversight, the non-IND studies, and the data would be presented to FDA after it shows promise in China. The companies would promise lower price for their drugs knowing fully well that FDA legally cannot consider that for its decisions or enforce drug pricing commitments made during the regulatory review process. It is this strategy that made FDA leaders worried and made them clarify their position about non-US data. So, now the Chinese companies would need to adjust their strategies a bit. First, conduct the clinical trial under an IND so FDA is aware of the trial from the beginning. Second, include a statistically powered fraction of the patients from countries outside China, preferably the US, while getting bulk of the clinical data from China. Third, discuss the clinical data with FDA in a timely fashion to make amends for any concerns raised by FDA reviewers prior to filing the market approval application. This would assure an FDA-acceptable application with China-rich global data. That’s how the US industry has been successful in getting FDA approvals with global data, and the same will be true for companies based in China as well.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC