FDA Authorizes Florida’s Drug Importation Program

 | by: Deneen Fumich, RPh | Article Posted: January 9, 2024 |

The U.S. Food and Drug Administration approves the first state request to import drugs from Canada. Announced on January 5th, the FDA has authorized Florida’s Agency for Health Care Administration’s drug importation program under section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This is the first step on this pathway toward Florida facilitating the importation of certain prescription drugs from Canada.

Florida, which filed its proposal with the FDA in 2020, initially wants to import drugs to treat chronic health conditions such as HIV/AIDS, mental illness, and prostate cancer, the governor’s office said in a press release Friday. The state would make the imported drugs available to patients at county health departments managed by the state Department of Health, inmates at state correctional facilities and certain others served by state agencies. The program would then expand to Medicaid enrollees.

Florida’s Agency for Health Care Administration secretary, Jason Weida, told state lawmakers last month, “We’re creating a system with importers and vendors that we as a state will import drugs from Canada, relabel them, get them to Florida and send them out through various state programs that way”. Florida’s SIP is authorized for two years from the date the FDA is notified of the first shipment of drugs to be imported. Among other obligations related to this SIP, before drugs can be imported, Florida’s Agency for Health Care Administration must:

• • Submit additional drug-specific information for the FDA’s review and approval.
  • Ensure that the drugs Florida seeks to import have been tested for, among other things, authenticity and compliance with the FDA-approved drugs’ specifications and standards.
  • Relabel the drugs to be consistent with the FDA-approved labeling.

Florida’s obligations under the FDA’s regulations will include, among other things: ensuring supply chain integrity, monitoring and submitting adverse event reports, complying with drug recall procedures, and reporting quarterly to the FDA. The sponsor of any program the FDA authorizes is responsible for implementing all aspects of their program such as importation and distribution.

Major hurdles remain before Florida can start importing certain medications, and it could be a while before the state and its residents see savings:

• • The drug industry is expected to continue its efforts to prevent the importation of drugs. Both the Healthcare Distribution Alliance (HDA) and Pharmaceutical Research and Manufacturers of America (PhARMA) have already voiced their concerns regarding the importing of unapproved medicines and the increased likelihood of counterfeit or substandard drugs entering a US closed distribution system.
  • Canada has opposed the mass importation of its medications. The Canadian government is concerned about its drug shortages. “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 US,” Health Canada said in a statement Friday evening.
  • Finally, Florida itself has many hurdles to set up the program, find vendors, and secure the supply chain following DSCSA.

Six other states, including Colorado, Maine, New Hampshire, New Mexico, Texas, and Vermont, have passed laws that would allow them to create state drug importation programs. Some are in various stages of seeking FDA approval. New Hampshire’s application was rejected in 2022 because it did not identify a Canadian wholesaler.

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