The FDA’s final rule allows the importation of certain prescription drugs from Canada under certain conditions.
Pharmacy groups oppose the FDA’s new final rule that legalizes the importation of drugs from Canada. The rule was published late last week.1
The final rule implements a provision of federal law that allows FDA-authorized programs to import certain prescription drugs from Canada under specific conditions. According to the FDA, the rule allows states, Indian tribes, and – in certain future circumstances – pharmacists and wholesalers, to submit importation program proposals to the agency for review and authorization.1
In a statement, the American Pharmacists Association (APhA) criticized the agency’s rule. According to APhA, the new rule jeopardizes patient safety by creating supply chain vulnerabilities that could potentially introduce counterfeit or unsafe drugs.
“APhA is disappointed that FDA would risk the safety and security of our nation’s drug supply by creating a complex and convoluted program allowing legal importation of certain drugs from Canada,” APhA said in a news release.2 “We believe FDA’s new drug importation program is not a safe way to reduce drug prices—and puts patients at risk.”
“Today’s final rule threatens our drug supply by creating opportunities for mischief that could introduce unsafe drugs into the US. The lack of clarity around unknown, unproven cost savings does not justify jeopardizing US supply chain integrity and patient safety,” said Ilisa Bernstein, PharmD, senior vice president of pharmacy practice and government affairs, for APhA.
Likewise, the American Society of Health-System Pharmacists (ASHP) is “deeply concerned that allowing wholesale importation of drugs will punch a massive hole in our nation’s drug supply chain, exposing patients to risks and potentially undermining an expensive track and trace system that’s in the midst of implementation,” said Tom Kraus, vice president of government relations for ASHP, in a statement provided to Drug Topics®.
“We are strongly supportive of efforts to reduce drug pricing, but not if, like importation, they come at the expense of patient safety with no guarantee of meaningful cost savings over the long term,” Kraus added.
“It also undermines the Drug Supply Chain Security Act (DSCSA), which creates ‘track-and-trace’ safeguards that do not exist in Canada. By commingling FDA-approved and imported versions in the marketplace, this program also creates pharmacy operation disruptions and product selection confusion and may limit patient access to medications by complicating insurance coverage and reimbursement at the pharmacy,” APhA noted.
Given the additional steps in the supply chain, such as relabeling and laboratory testing requirements, additional reporting systems, and the fact that most high-cost drugs are excluded from the program, importing drugs from Canada will not produce significant cost savings to American consumers, according to APhA.
In December 2019, APhA, NCPA, ASHP, and several other pharmacy organizations and consumers joined together to oppose the proposed FDA rule.
“FDA failed to consider the thousands of comments that opposed finalizing this program. We will continue to explore ways to protect patients and the drug supply from the perils that importation may bring and to ensure patient safety is not compromised,” APhA said.
1. Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, and Combination Products under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry. FDA; September, 2020. Accessed September 28, 2020. https://www.hhs.gov/sites/default/files/importation-guidance.pdf
2. APhA: New federal drug importation program puts patients at risk. News release. APhA; September 25, 2020. Accessed September 28, 2020. https://www.pharmacist.com/press-release/apha-new-federal-drug-importation-program-puts-patients-risk