The US Food and Drug Administration ("FDA") announced last Friday that it had approved a drug importation program proposed by Florida’s Agency for Health Care Administration under section 804 of the Federal Food, Drug and Cosmetic Act . Through this section 804 importation program (also called a “SIP” under the implementing rule, 21 CFR 251), Florida is authorized to import certain eligible prescription drugs from Canada; however, trade is a two-way street. In response, Health Canada released a statement on January 8, 2024 that the Government of Canada was “taking all necessary action to safeguard the drug supply and ensure Canadians have access to the prescription drugs they need”.

Drugs that are eligible to be imported to Florida, according to the implementing rule, are those that have received a Notice of Compliance and a Drug Identification Number  from Health Canada and that meet the conditions in an FDA-approved new drug application or abbreviated new drug application for a drug that is currently commercially marketed in the United States.[1] Of note, certain types of drugs cannot be imported under the SIP.[2] The FDA may approve SIP “proposals from states or Indian tribes to import certain prescription drugs from Canada if the SIP will significantly reduce the cost to the American consumer without imposing additional risk to public health and safety”.[3] Applicants seeking approval also must provide certain information set out in the applicable legislation, including the Federal Food, Drug and Cosmetic Act and the FDA Regulations. The FDA will oversee the program and ensure it continues to meet the requirements of section 804.

In response to the FDA’s approval of the Florida SIP, Health Canada’s statement released on January 8, 2024 references portions of Canada’s Food and Drugs Act (R.S.C., 1985, c. F-27) that prohibit certain drugs intended for the Canadian market from being sold for consumption outside of Canada if that sale could cause, or worsen, a drug shortage in Canada, confirming that these provisions would apply to drugs that are eligible for bulk importation into the US. According to the statement, regulated parties have been informed of their obligation to refrain from distributing a drug to another person for consumption outside of Canada “unless the person holding the licence has reasonable grounds to believe that the distribution will not cause or worsen a shortage of the drug in Canada and has retained detailed records of the information relied upon to make that determination.” Sanctions for non-compliance range from Health Canada requesting a plan for corrective measures or issuing a public advisory or other forms of communication, to taking action on the licenses of regulated parties who contravene the export prohibition.

How successful Florida will be at obtaining Canadian drugs in the face of Health Canada’s response remains to be seen.

If you are considering exporting products to Florida in light of the new FDA-approved SIP, or have concerns about this issue, and require legal assistance, McCarthy Tétrault LLP would be pleased to assist.    

[1] 21 CFR 251.2 “Eligible prescription drug”

[2] Ineligible drugs include biologic drugs, drugs that are infused, intravenously injected, inhaled during surgery intrathecally or intraocularly injected, among others (21 CFR 251.2 “Eligible prescription drug”)

[3] https://www.fda.gov/news-events/press-announcements/fda-authorizes-floridas-drug-importation-program