A bipartisan proposal from U.S. Sens. Gary Peters (D-MI) and Susan Collins (R-ME) seeks increased transparency through stronger requirements on foreign manufacturers of medical products utilized in the U.S., increasing those needing to register with the Food and Drug Administration (FDA).
“Our nation’s longstanding dependence on foreign manufacturers for critical drugs and medical supplies continues to present a serious public health and national security risk. The FDA needs to know exactly where these important products are made at every step of the manufacturing process to ensure safety, anticipate possible shortages, and prepare for future public health challenges,” Peters, chairman of the Homeland Security and Governmental Affairs Committee, said. “This commonsense, bipartisan bill will help increase visibility into our medical supply chain and provide the FDA with a clearer picture of foreign-made medical products to help ensure they are safe and effective for all Americans.”
The Registration of Certain Foreign Establishments Act’s introduction followed a recent FDA report that stated approximately 78 percent of facilities producing active pharmaceutical ingredients (APIs), or key ingredients that make drugs do what they are supposed to, are based outside of the U.S. Some of these manufacturers have failed to register with the FDA, limiting its ability to see where certain drugs are made and how much, crippling its oversight capabilities. The senators seek to add to current law and require foreign manufacturers to register with the FDA, complete with information on their facilities involved in the production process.
“During the ongoing public health emergency, the last thing patients should have to worry about is whether there will be an adequate supply of the medications they need,” Collins, a member of the Health, Education, Labor and Pensions Committee, said. “Given that nearly 80 percent of active pharmaceutical ingredient manufacturing facilities are located overseas in countries like China and India, it is important for the FDA to have greater visibility into the drug supply chain. Our legislation will help prevent disruptions of medications and builds on the drug manufacturing reporting requirements in the MEDS Act I co-authored that became law in 2020.”
Any foreign manufacturer with the distribution of medical products in the United States — whether they are active pharmaceutical ingredients, finished drugs, or personal protective equipment — would have to register with the FDA upon passage of this legislation. They would need to identify where manufacturing occurred, even if it were spread across multiple nations.