A proposed program by the state of Florida to import certain prescription drugs from Canada has received the approval of the United States Food and Drug Administration (FDA): FDA news release on January 5, 2024.
Background
In 2020, the U.S. created a pathway – as published in a final rule on Importation of Prescription Drugs on October 1, effective November 30 – to allow importation of eligible prescription drugs from Canada.
Under the Federal Food, Drug, and Cosmetic Act, the FDA can authorize Section 804 Importation Program (SIP) proposals by states or Indian tribes that demonstrate the program will significantly reduce the cost of covered products to the American consumer and will pose no additional risk to public health and safety. Some categories of drugs are excluded, such as biological products, infused drugs, and intravenously injected drugs.
Recognizing that diversion of drugs from the Canadian market would increase the risk of drug shortages harming Canadians, and referring to the U.S. framework, Canada quickly introduced measures to help prevent such bulk importation programs from causing or exacerbating a drug shortage in Canada.
On November 27, 2020, the Minister of Health issued a one-year Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply), which prohibited a drug establishment licence (DEL) holder from distributing certain drugs for consumption or use outside Canada unless the DEL holder has reasonable grounds to believe that the distribution will not cause or exacerbate a shortage of the drug.
On November 28, 2021, the Interim Order provisions were made permanent through amendments to the Food and Drug Regulations. Health Canada also released a related guidance document, Guide to distributing drugs intended for the Canadian market for consumption or use outside of Canada (GUI-0145).
Authorization of Florida’s program
On January 5, 2024, the FDA authorized Florida’s SIP proposal. This is the first step in the pathway toward Florida facilitating importation of certain listed drugs from Canada. As detailed in the Letter of Authorization, Florida must meet further statutory requirements before drugs can be imported, including testing and relabeling of the prescription drugs. Florida’s SIP is authorized for two years from the date the FDA is notified of the first shipment of drugs to be imported.
Health Canada’s response
Health Canada released a Bulletin and Statement on January 8, 2024, addressing the FDA decision.
The bulletin (“Regulatory requirements prior to distributing Canadian drugs outside Canada”) reminds stakeholders of relevant obligations: Under the Food and Drug Regulations, DEL holders must not distribute certain Canadian-authorized and labelled drugs for use outside Canada if this could cause or worsen a shortage. The bulletin also indicates Health Canada is monitoring the situation in Florida and in other states where the FDA is reviewing importation program proposals.
Touching on Canada’s position on the use of bulk importation programs, the statement emphasizes:
… The Government of Canada is taking all necessary action to safeguard the drug supply and ensure Canadians have access to the prescription drugs they need and has been clear in its position: bulk importation will not provide an effective solution to the problem of high drug prices in the U.S.
Health Canada states it will not hesitate to take immediate action to address non-compliance, ranging from requesting a plan for corrective measures, issuing a public advisory or other forms of communication, to taking action on the licences of regulated parties who contravene the export prohibition if warranted.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group.
The preceding is intended as a timely update on Canadian intellectual property and life sciences regulatory law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.