The Food and Drug Administration laid out a road map for prescription drug importation from Canada, a policy that has been touted as a means of lowering costs for Americans.
The FDA released guidance for importation late Wednesday evening, saying that licensed state wholesalers and pharmacists can import drugs from Canada for up to two years as long as the medications have undergone rigorous safety and authenticity testing. The final rule also stipulates that foreign sellers must be licensed to offer wholesale drugs by the FDA and Health Canada, the Canadian equivalent.
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“The purpose of the final rule is to achieve a significant reduction in the cost of covered products to the American consumer while posing no additional risk to the public’s health and safety,” the agency said.
Not all drugs will be authorized for importation, however. The rule excludes controlled substances, infusion treatments such as dialysis solution, injectable drugs, drugs that are inhaled during surgery, drugs that are administered in the eyes, and those that fall under the FDA’s regulation of certain medications with serious safety concerns, known as the Risk Evaluation and Mitigation Strategy program, or REMS.
“Essentially, eligible prescription drugs are those that could be sold legally on either the Canadian market or the American market with appropriate labeling,” the plan said.
Former President Donald Trump first proposed drug importation as a salve for sky-high prescription drug prices, reforms on which Congress has fumbled in recent years. Despite Trump’s enthusiasm for the program, which attracted the support of Florida Gov. Ron DeSantis, the Department of Health and Human Services was lukewarm. Still, the FDA rule was finalized in October 2020 toward the tail end of Trump’s presidency.
The Biden administration has resurrected the plan as legislation to reduce drug prices has struggled to gain traction. Despite staunch Republican opposition, the Democratic Party has introduced legislation several times that would give Medicare, the federal health program for seniors, the authority to negotiate drug costs with manufacturers. It remains stalled in the Senate with little chance of advancement.
Canada, meanwhile, where government controls keep prices lower, has opposed U.S. plans to pass importation policies out of concern for its own country’s drug supply and cost increases. The Canadian foreign ministry told officials in the country in 2019 that “Canada does not support actions that could adversely affect the supply of prescription drugs in Canada and potentially raise costs of prescription drugs for Canadians.”
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The pharmaceutical industry has also objected to importation proposals, citing concerns that the medications coming from Canada are not guaranteed to be safe for Americans to consume. Counterfeit, substandard or diverted, repackaged, and adulterated drugs could be introduced into the U.S. drug supply chain if drug importation plans are allowed to move forward, according to the pharmaceutical industry trade group PhRMA.
“The prevalence globally of counterfeit COVID-19 vaccines provides proof that the threat of counterfeit drugs is a very real and dangerous threat, yet the current administration is continuing to push forward a drug importation scheme from the Trump Administration," said PhRMA spokeswoman Nicole Longo. "Drug importation schemes make it even easier for criminal organizations to bring counterfeit drugs, including pills laced with fentanyl, into the United States, putting Americans in harm’s way."