Congresswoman Doris Matsui. Courtesy photo

WASHINGTON, D.C. (MPG) – Congresswoman Doris Matsui (D-CA-07) and Representatives Dan Crenshaw (R-TX-02), Ashley Hinson (R-IA-02) and Kim Schrier (D-WA-08) recently 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.”

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, and by 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 at matsui.house.gov/sites/evo-subsites/matsui.house.gov/files/evo-media-document/matsui_025_xml.pdf

The bill is endorsed by the Association for Clinical Oncology, Vizient and the American Society of Health-System Pharmacists.