The Trump administration last week released a proposal that, if finalized, would allow states, wholesalers, and pharmacies to creep toward importing drugs from foreign nations. A second proposed policy would allow manufacturers to import their own products sold abroad. The policies must survive multiple regulatory hurdles—which could take months or years—before they can be implemented.
Pharmacy organizations and advocates have long asserted that importation poses an unacceptable threat to public safety. Other importation skeptics question whether the process of shipping and redistributing drugs under the proper conditions would result in net savings. It would require ensuring drugs are genuine and have not been adulterated or tampered with, and relabeling them so labels conform to U.S. regulations and standards—which would involve physically placing new labels on each bottle.
Other criticisms raise concerns about whether Canada’s drug supply, subject to the same shortages that occur in the United States and serving significantly fewer residents, could meet the needs of a population of a nation nearly 10 times its size.
Still, safety is the most persistent and intractable concern. In a statement released on Wednesday, December 18, APhA said “[The] safeguards to protect Americans … to ensure that prescription drugs are manufactured, stored, shipped, and dispensed in a safe manner would be undermined if this proposal is finalized as written. This would have a negative effect on patient confidence in the safety of their medications.”
FDA’s proposed rule creates a patchwork of interim supply chain measures that introduce gaps and loopholes in the supply chain, even as U.S. pharmacists and other drug supply chain stakeholders have worked for years to implement the Drug Supply Chain Security Act (DSCSA). Also known as track-and-trace, DSCSA creates a closed supply chain to “track and trace” prescription drugs as they move from manufacturer to distributor to pharmacist. Canada has no such safeguards.
Though U.S. Department of Health and Human Services Secretary Alex Azar in May 2018 referred to importation as a “gimmick,” adding that “the last four FDA commissioners have said there is no effective way to ensure drugs coming from Canada really are coming from Canada, rather than being routed from, say, a counterfeit factory in China,” his tone has softened.
“We will move as quickly as humanly possible here,” Azar stated on December 17, 2019. “President Trump is fervently committed to bringing down drug prices, fervently committed to the importation of safe drugs from Canada.”
APhA remains alarmed by the idea. “[The FDA] proposal undermines the DSCSA’s protections by introducing unsecure foreign prescription drug packages into our drug supply and commingling them with secure FDA-approved products,” APhA said. “The lack of clarity around unknown, unproven cost savings does not justify jeopardizing U.S. supply chain integrity and patient safety.”
