Washington, D.C. (Updated June 13, 2022) – Shabbir Imber Safdar, executive director of the Partnership for Safe Medicines, released the following statement in advance of the Senate HELP Committee’s June 14th Executive Session.
“The amendments offered to include foreign drug importation in S. 4348, Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act, are a dangerous step toward opening the secure American drug supply chain to illegitimate, substandard, and deadly counterfeit medicines, including counterfeits made with fentanyl-related substances. Congress must bear in mind that these proposals to import medicines from foreign countries -- Canada, the United Kingdom, and elsewhere -- are unworkable for many reasons.
“Drug importation schemes like this one would give unregulated actors a green light to enter our supply chain at a time when law enforcement is already struggling to keep up with the sheer volume of counterfeits made with fentanyl that are killing more Americans than ever before.
“Even before the current fentanyl crisis, FDA Commissioner Robert Califf and three prior commissioners all called importation a ‘risky approach’ that ‘will not achieve the aim.’
“Canada, the first country proposed as a source for Americans' medication, has been unwilling to participate in this exchange. PSM has been tracking Canadian voices and actions on this topic, and, in 2020, the Canadian government created new regulatory restrictions on the export of drugs to the U.S.
“As politicians propose these schemes, there are millions of seized counterfeit COVID-19 medical products sitting in warehouses, a grim reminder that going outside the U.S.’s closed, secure drug supply chain rarely delivers safety or savings.
“Logistically, the proposal is destined to collapse. Past policies, including those in Illinois, Minnesota, and Maine, have all failed. In addition to being plagued with safety issues, the policies didn’t generate savings for patients – negating the whole purpose. PSM urges Senators to excise this proposal and enact a package free of poison pill policies that would only act to undermine the entire purpose of the User Free program.
About the Partnership for Safe Medicines
The Partnership for Safe Medicines (PSM) is a public health group comprised of non-profit organizations that handle medicine from the factory floor to the patient and are committed to the safety of prescription drugs. To learn more, visit www.safemedicines.org.