U.S. lawmakers urge HHS to expand domestic manufacturing, technologies for pharmaceutical stockpile

In a letter dispatched last week, five U.S. representatives called on Health and Human Services Secretary Xavier Becerra to tap domestic manufacturing and new technologies to grow the national stockpile of important pharmaceuticals and reduce reliance on foreign production.

Although the lawmakers stressed the importance of self-reliance in general, they had a particular eye on China with this effort. They noted that China has, for example, been the largest producer of active pharmaceutical ingredients used by the Strategic National Stockpile (SNS) for more than a decade. It’s estimated that Chinese manufacturers make approximately 40 percent of all APIs used worldwide.

“The coronavirus pandemic exposed serious vulnerabilities in our critical supply chain of lifesaving medications,” U.S. Rep. Bill Posey (R-FL) said. “With a majority of key pharmaceuticals imported to the United States from China, a supply disruption of any origin, whether by design or mistake, could put American patients in danger.”

When combined with India, that corner of the world makes 75-80 percent of all APIs imported to the United States. While this has historically had its advantages, dangers became realized last year, when India’s Ministry of Commerce and Industry restricted the export of 13 APIs and any formulations made from them, even as the COVID-19 pandemic got underway.

“The centralization of the global supply for essential ingredients for drugs in China and India makes it vulnerable to interruption, whether by mistake or design,” the lawmakers wrote in their letter. “If disruptions occur for an essential ingredient made in China, the United States will wait in line with other countries around the world to obtain it. This places the American patient at great risk.”

As a result, the members of Congress called for giving preference to domestically sourced APIs for any pharmaceutical products purchased for the SNS. This, they argued, would also accelerate domestic companies’ transition to new manufacturing technologies that could allow for a more sturdy and flexible supply of essential medicines.

A briefing from Becerra and the HHS was requested before Sept. 30, 2021, focusing on any steps being taken by HHS to prioritize the purchase of SNS-slated APIs from domestic sources.

“We simply cannot outsource our public safety and national security to foreign nations,” U.S. Rep. Brian Fitzpatrick (R-PA) said. “We must reconstitute our healthcare and public safety supply chain back to the United States. Medical products, protective equipment, pharmaceuticals, emergency response equipment, and all other critical items and materials needed to respond to a national emergency must be produced domestically for domestic consumption, especially during a critical, time-sensitive crisis.”