WASHINGTON, D.C. - Today, Congresswoman Doris Matsui (D-CA-07) and Representatives Dan Crenshaw (R-TX-02), Ashley Hinson (R-IA-02), and Kim Schrier (D-WA-08) introduced the bipartisan Drug Origin Transparency Act, legislation to give the Food and Drug Administration (FDA), health care providers, and purchasers better visibility into where prescription drugs and their key ingredients are actually made.
As it stands, the public and even FDA do not have a full picture of where a drug originates or where its active ingredients come from. That lack of transparency makes it harder to detect vulnerabilities in the supply chain, respond to disruptions, and prevent shortages before they reach patients in need.
"When a patient cannot get the medicine they need, nothing else matters. Families are left waiting, doctors are left scrambling, and too often no one has a clear answer for why it happened," said Congresswoman Matsui. "That is unacceptable. This bill gives FDA and the public a clearer picture of where our drugs and their ingredients come from so we can catch risks earlier, respond faster, and better protect patients from life-threatening shortages."
"We've allowed critical parts of our pharmaceutical supply chain to drift overseas - often to countries that don't share our interests - and we still lack full visibility into the risks it creates. That's unacceptable," said Congressman Crenshaw. "This bill forces transparency so we know exactly where our drugs and their ingredients are coming from. You can't fix a supply chain you can't fully see."
"For far too long, we've relied on China for critical medications Americans depend on every day - that's a serious national security and public health risk," said Congresswoman Hinson. "This bipartisan bill brings much-needed transparency to our pharmaceutical supply chain so we know exactly where our medicines are coming from and can start bringing that production back home. I'm proud to help lead this bipartisan effort to strengthen American manufacturing and reduce our dependence on foreign adversaries for critical medications."
"As a pediatrician, I know how devastating drug shortages can be for patients," said Congresswoman Schrier. "Our pharmaceutical supply chain is heavily reliant on foreign countries, which presents a threat to national security; and the complicated manufacturing process often leaves everyone from patients to the FDA without the critical information they need. This legislation would provide transparency in every step of the process, help ensure we have redundant or domestic sources for the most important medications, and ultimately ensure Americans have access to safe, effective medications."
The Drug Origin Transparency Act would strengthen oversight of the pharmaceutical supply chain by:
-
Allowing FDA to require more detailed reporting on the suppliers of each active pharmaceutical ingredient and intermediate product, including how much of those materials each supplier manufactures.
-
Requiring the drug label to identify the original manufacturer, the original manufacturer of the active pharmaceutical ingredient, and any other manufacturer, packer or distributor involved in the supply chain.
Current law requires manufacturers to report to FDA the annual amount of drug they produce, but that alone does not show where key ingredients originate or how reliant manufacturers are on specific suppliers. Drug labels only identify the final manufacturer, packer or distributor, even though critical parts of a drug's supply chain may lie elsewhere.
Full text of the legislation can be found HERE.
The bill is endorsed by the Association for Clinical Oncology, Vizient, and the American Society of Health-System Pharmacists.