The FDA may halt approval on some cancer drugs and other medications being developed in China after concerns were raised over the whether the results of drug studies carried out in the country could be applied to the US population.
Regulators also raised concerns that some of the studies use outdated designs, ultimately questioning the quality of the studies themselves.
“We have nothing against drugs being developed in China,” the director of the FDA’s cancer-drugs division,Richard Pazdur, told The Wall Street Journal. “Our issue is, are those results generalisable to the US population?”
The potential U-turn on drug approvals comes as drugmakers Eli Lilly and Novartis AG look to bring the medicines to the US from China – in what would have potentially netted the companies billions of dollars.
Drugs produced in China account for a significant share of the US drug market, with the FDA reporting in 2018 that China “ranks second among countries that export drugs and biologics to the United States by import line”.
A reluctance from regulators to approve drugs developed in China is also likely to have an impact on relations between the two nations.
