Tallahassee, Fla. – Today, Governor Ron DeSantis announced the Agency for Health Care Administration (AHCA) officially submitted its concept paper to the U.S. Department of Health and Human Services (HHS) for Florida’s Canadian Prescription Drug Importation Program. With this milestone achievement, Florida continues to drive the national conversation on reducing prescription drug prices for individuals and families in need.

“Floridians have been paying intolerably high prices for prescription drugs in Florida for too long,” said Governor DeSantis. “Two months after signing Florida’s Prescription Drug Importation Program into law, I am pleased to announce that our state is one step closer to realizing true cost savings on safe, high quality prescription drugs from Canada. I thank Secretary Mayhew for prioritizing this concept paper and moving us closer to implementing Florida’s Program. I commend President Trump for his commitment to this effort and his clear direction to the U.S. Department of Health and Human Services to expedite a pathway for the safe importation of prescription drugs.”

“Since taking office Governor DeSantis has made health care reform one of his top priorities, and this week we have taken the next step in working to make sure Floridians have access to affordable prescription drugs,” said AHCA Secretary Mary Mayhew. “No one should have to forego prescription medicines because of high prices. We have seen unprecedented support from President Trump who realizes this work is vital to improving the lives of the American people, and I thank both Governor DeSantis and President Trump for their steadfast attention to this issue.”

The concept paper outlining Florida’s plan for the wholesale importation of safe, high quality, low-cost prescription drugs from Canada was sent to HHS on Wednesday, August 21. The concept paper is a model to inform HHS as they develop rules in line with President Trump’s recent directives on the importation of prescription drugs. See here for the official document. Based on the strength of the Program design articulated in this concept paper, Florida is confident HHS Secretary Azar can certify to Congress that the implementation of a prescription drug importation program poses no additional risk to the public’s health and safety and will result in cost savings.

While this concept paper only discusses importation to state entities, Florida’s new law does not and should not be interpreted to prevent importation from private wholesalers and pharmacies, which is the purpose of 21 U.S.C. § 384. The State of Florida welcomes and fully supports importation to private entities.

On June 11, Governor DeSantis signed House Bill 19 into law establishing the Program within AHCA, the chief health policy and planning entity for the State of Florida.

The purpose of the Program is to facilitate the commercial importation of prescription drugs into Florida from approved Canadian suppliers. The list of prescription drugs that are imported under the Program must have the greatest potential for savings to the State. House Bill 19 allows the importation of drugs that meet the United States Food and Drug Administration (FDA) standards related to safety, effectiveness, misbranding, and adulteration.

The Agency is required to contract with a vendor that will manage and oversee all aspects of the Program and ensure Canadian suppliers and eligible importers comply with all federal and state law requirements. Eligible importers will be limited to wholesalers and pharmacists that are dispensing prescription drugs to consumers served by certain state and government programs. Florida’s Program must also comply fully with Title II of the Federal Drug Supply Chain.

Under the President’s leadership, HHS in late July published the Safe Importation Action plan that outlined measures HHS and the FDA will take to allow for the safe importation of certain prescription drugs. AHCA will continue working earnestly with HHS through their proposed rulemaking to deliver on President Trump and Governor DeSantis’ promise of making safe, high quality, low cost prescription medicines available for individuals and families in Florida.



Comments are closed.