FDA Needs More Data on China Drug Production: Report

The U.S.-China Economic and Security Review Commission, which was created by Congress in 2000, says it is difficult to tell how entrenched China is in manufacturing drugs used in the U.S. because FDA “doesn’t collect data on where the basic building blocks of medicines are made.” A Bloomberg Europe 11/18 report says the commission recommends that Congress develop legislation to require companies to provide the information to the agency.

A commission report says that about 25% of generic drugs taken by Americans rely on ingredients from China. “With China’s recent restrictions on rare earth minerals top of mind,” Bloomberg says, “the commission said that similar moves involving drug ingredients ‘could have drastic consequences for the U.S. healthcare system, causing supply shocks that would result in loss of lives and force hospitals to make tough choices in allocating insufficient supply.’”

Bloomberg reports that a 2024 Biotechnology Innovation Organization survey found that 79% of 124 biopharmaceutical companies had China-based development and manufacturing partners. The report says most biotech companies lack the resources o make drugs in the U.S., a priority for the Trump administration.

It reports that FDA commissioner Marty Makary raised the possibility last month of the agency lowering the review user fees charged to companies if they conduct early-stage studies in the U.S. rather than China. He told a gathering of pharmaceutical supply chain executives that FDA is looking to negotiate such a process in upcoming user fee reauthorization talks.

Many manufacturing plants in China and India have struggled to meet U.S. standards, the report says. FDA inspectors often cite them for not adhering to manufacturing practices meant to ensure the safety and quality of medications.

In the end, the report authors conclude, fixing supply chain vulnerabilities will require a wholesale approach, take years, and be hard to achieve. It will require “significant modifications to U.S. and global economic statecraft, tools, and approaches,” including efforts to bolster domestic manufacturing, they said.

While the Trump administration has secured commitments from some large drugmakers to open manufacturing plants here, they don’t include generic companies that can’t afford it. Recently imposed restrictions and reductions in research funding at U.S. universities and other institutions also could limit America’s chances at extracting itself from China’s grasp, Bloomberg says.