On July 31, 2019, the United States Department of Health and Human Services (HHS), in conjunction with the Food and Drug Administration (FDA), announced a Safe Importation Action Plan outlining two possible pathways to lay the foundation for the importation of drugs originally intended for foreign markets.
The first pathway would publish a notice of proposed rulemaking (NPRM) that would rely on the authority under the Federal Food, Drug, and Cosmetic Act (FD&C Act) Section 804 that would, when the rule is finalized, authorize demonstration projects developed by states, wholesalers, or pharmacists. The demonstration projects would outline how they would import certain drugs from Canada that are versions of FDA-approved drugs, manufactured consistent with FDA approval.
The second pathway would consist of FDA-created guidance documents, through which the FDA would provide recommendations to manufacturers of FDA-approved drugs who seek to import versions of those drugs they sell in foreign countries. Manufacturers would use a new National Drug Code (NDC) for those products, which would possibly allow them to offer a lower price than what their current distribution contracts require. The manufacturer would have to establish with the FDA that the foreign version is the same as the U.S. version and appropriately label it for sale in the United States. According to HHS, this pathway may be “particularly helpful to patients with significantly high cost prescription drugs,” including insulin, and medications used to treat rheumatoid arthritis, cardiovascular disorders, and cancer.
Comments on the Plan
Supportive Comments
HHS Secretary Alex Azar spoke highly of the pathway presentation and urged Congress to continue working on lowering drug costs, stating, “We’ve been very pleased to see Congress take significant interest on the issue of high drug prices and out-of-pocket costs. Action from Congress would help secure lasting improvement on many of the areas for action that the President laid out in his drug-pricing blueprint last year.”
Senator Lamar Alexander, Senate Health Committee Chairman, voiced his support for the move. “This is the first administration to take concrete steps to allow importation of prescription drugs to reduce their cost and I welcome it,” he said. “The key for me is whether this plan preserves the Food and Drug Administration’s gold standard for safety and effectiveness. Millions of Americans every day buy prescription drugs relying on the FDA’s guarantee of quality.”
Adverse Comments
PhRMA president and CEO Stephen Ubl has some concerns about the plan, saying, “The Administration’s importation scheme is far too dangerous for American patients. There is no way to guarantee the safety of drugs that come into the country from outside the United States’ gold-standard supply chain. Drugs coming through Canada could have originated from anywhere in the world and may not have undergone stringent review by the FDA. Law enforcement has repeatedly warned that importation schemes could worsen the opioid crisis and jeopardize public safety. Moreover, Canadian officials have said that the policy is unworkable, and they will not risk shortages by diverting their medicine supply to the United States.
Ubl also alluded to a change of heart Secretary Azar seems to have had, “In the words of Secretary Azar just last year, drug importation is a ‘gimmick’ and ‘the last thing we need is open borders for unsafe drugs.’ Rather than surrender the safety of Americans by importing failed polices from single-payer countries, we should work on solutions here at home that would lower patient out-of-pocket costs at the pharmacy counter.”
Canadian pharmacists and others within HealthCanada have also expressed concerns about allowing such imports, that it may create shortages or raise costs for Canadians.