Impact of FDA China Cell Rule Unclear: Experts
Experts interviewed for an online Clinical Trials Arena post have differing opinions on the impact of a recent FDA rule barring new clinical trials that involve sending U.S. citizens’ living cells to China and other “hostile” countries for genetic engineering before they are returned to be infused into the patients. “The scope is a little unclear currently,” said Project Farma CEO Anshul Mangal. “FDA has not said how many trials are affected, but the policy could potentially affect cell therapies, for example, CAR-T, where manufacturing steps sometimes occur overseas.”
The post says it is hard to say how many U.S. companies use Chinese contract development and manufacturing organizations for cell and gene therapy trials. Some experts think there are many companies involved, it says, while others think it may not be standard practice due to logistics.
Smaller biotech companies can be attracted to China due to the lower costs, the article says. It quotes Cytoart general manager Frank Li as saying that using Chinese facilities may be common practice and the FDA ruling will, in the future, affect the number of cell and gene therapy trials available to U.S. patients. However, Dark Horse Consulting founder Anthony Davies says, “I do not believe this is a particularly common practice in clinical trials. Most of the time, autologous therapies are not sent abroad to China. In fact, they’re not often sent abroad at all because it’s an extremely inefficient way of doing it. Shipping them around the country is hard enough. Shipping it internationally and you’re suddenly dealing with customs, which can cause potential delays.”
Shifting from Chinese to American contract development and manufacturing organizations could mean pipelines are restructured or that companies cancel upcoming studies while they try to manage increasing costs, the post says.
“Sponsors will need to redesign the protocols so that all cell processing occurs domestically, or at least not in countries that are subject to restriction,” Mangel says. “This could potentially delay timelines if you’re a U.S. company that has cell processing occurring in China.”
Li says one strategy companies may consider is to run studies in China to establish proof of concept before transitioning to the U.S., where studies will cost more.
“If China data cannot be accepted,” Li also says, “Europe is good, and Australia is also a possibility. This will affect Americans and create more burden to some companies, especially small biotech and startups.”