Bipartisan Discussion Draft Would Enhance Security & Protect America’s Patients
WASHINGTON, DC – The Subcommittee on Health, chaired by Rep. Joe Pitts (R-PA), today held a hearing on “Securing our Nation’s Prescription Drug Supply Chain” and discussed bipartisan draft legislation to secure the pharmaceutical supply chain. The draft legislation would enhance the security of the pharmaceutical distribution supply chain for America’s patients while preventing duplicative federal and state requirements. The draft would establish a collaborative, transparent process between the Food and Drug Administration and stakeholders in order to better understand how and when to move to unit-level traceability.
“While some supply chain provisions were included in Title VII of last year’s FDA user fee bill, the Food and Drug Administration Safety and Innovation Act (FDASIA), a comprehensive ‘track and trace’ package has yet to be finished,” stated Chairman Pitts.
Energy and Commerce Committee Chairman Fred Upton (R-MI) added, “Now it is time to move this legislation down the field and across the goal line. Because of the hard work that already has been put in on this issue, I am confident we can get a product to the president’s desk by the August recess. I commit today that I will do all that I can to make it happen, including marking up the legislation in the committee in May.”
Timothy Davis, an independent pharmacist and member of the National Community Pharmacists Association testified, “We need a reasonable, commonsense federal approach that will strike the appropriate balance between enhanced patient safety and minimizing unreasonable burdens on supply chain stakeholders, particularly small business pharmacies like myself.”
In supporting the legislation, Rep. Latta, one of the bill’s authors, added, “This important draft legislation will ensure greater patient safety for all Americans. In addition to providing uniformity for states, it will prevent burdensome regulations. I look forward to working with committee to advance this legislation forward.”
For more information on today’s hearing, including archived video and witness testimony, please click here.