On June 8, 2022, PILMA released the following statement on drug importation legislation and PDUFA.
PILMA has a long history of opposing importation of foreign biopharmaceutical products into the U.S. due to the impact on U.S. construction jobs and patient safety.
Congress is considering adding a prescription drug importation provision to the reauthorization of the Prescription Drug User Fee Act (PDUFA). PILMA urges caution and consideration of any riders accompanying this important piece of legislation.
PDUFA funds key functions of the Food and Drug Administration. The timely reauthorization of this program—which enables the collection of fees from biopharmaceutical companies to help fund the FDA’s ability to review and approve new medicines—is essential and should be considered separately from any importation proposals.
The U.S. biopharmaceutical industry drives economic growth, providing over 900,000 jobs in the U.S. From 2015 – 2020, the industry invested $23.6 billion in infrastructure investment across 14 states providing high-quality construction jobs to union members.
The risks associated with importing medicines and their components from foreign countries are well documented. The U.S. has a long-established closed prescription drug distribution system, which allows medicines to be tracked to maintain a safe drug supply. Unscrupulous actors attempt to penetrate unsecured systems with counterfeit or adulterated drugs, which have sometimes fatal consequences to patients.
Importation schemes could further stress global supply chains already under tremendous constraints. Given these ongoing challenges, countries around the world are seeking to protect their own drug supply chains more rigorously than ever before. By sourcing through irregular channels, importation would further strain overseas supply chains, which could have negative implications for American supplies of medicines.