Grassroots effort is aimed at pharmacist action on drug importation
APhA, warning that importation jeopardizes patient safety and the security of the U.S. drug supply chain, has launched a grassroots effort and call to action to challenge FDA's December 23, 2019, proposed rule on importing drugs from Canada.
U.S. Health and Human Services Secretary Alex Azar at one time dismissed the idea of importing drugs from Canada as a way to secure lower prices as a “gimmick.” But with the release of a December 23, 2019, FDA draft guidance and proposed rule, importation from Canada has a pathway toward reality. APhA, which has warned that importation jeopardizes patient safety and the security of the U.S. drug supply chain, has now launched a grassroots effort to educate pharmacists and help them submit comments to FDA by the agency’s March 9, 2020, deadline. Access the call-to-action page, created in partnership with the National Alliance of State Pharmacy Associations (NASPA), at www.pharmacist.com/drug-importation.
At www.pharmacist.com/drug-importation, pharmacists will find a video explaining how a drug importation program designed under the December 23 proposed rule would work and an overview of associated concerns. Pharmacists can also download a background document with more information on how the proposed importation program affects pharmacies and patients and use provided templates to send comments to FDA by the March 9, 2020, deadline. The page includes detailed instructions on how to submit comments.
“Pharmacists are the gatekeeper of safe medications between the supply chain and their patients,” said Ilisa Bernstein, PharmD, JD, FAPhA, APhA senior vice president of pharmacy practice and government affairs. “But the safeguards currently in place to protect Americans would be undermined if this proposal is finalized as written.” Critics of the Trump administration’s efforts to institute importation channels, including APhA, say FDA’s proposed scheme would allow the introduction of risky products into the drug supply chain without any proof that doing so would save money for patients or the health care system.
Pharmacists and other drug supply chain stakeholders have been working for years to implement the Drug Supply Chain Security Act (DSCSA), also known as “track and trace,” which adds new protections to further secure our nation’s drugs. DSCSA creates a closed supply chain to track and trace prescription drugs as they move from manufacturer to distributor to pharmacist. Canada does not have such safeguards.
“FDA’s proposed rule creates a patchwork of interim supply chain measures that introduce gaps and loopholes in the supply chain as drugs are distributed from Canada into the U.S.,” Bernstein said.