FDA directed to work with states on importation program plans


TALLAHASSEE, Fla. – Nearly eight months ago, under the leadership of Governor Ron DeSantis, Florida submitted its Section 804 Importation Proposal (SIP) to the U.S. Department of Health and Human Services (HHS) for our state’s Canadian Prescription Drug Importation Program – the first in the nation to do so. Today, President Biden directed the U.S. Food and Drug Administration (FDA) to work with states and tribes to safely import prescription drugs from Canada as outlined in the FDA’s implementing regulations based in part off Florida’s 2019 importation concept paper.


Since taking office, Governor Ron DeSantis has prioritized lowering the cost of prescription drugs for Floridians. In 2019, the Florida Legislature passed several pieces of legislation, including Florida’s Canadian Drug Importation Program, to reform Florida’s health care market by increasing transparency, empowering patients, and reducing costs. Florida’s Canadian Drug Importation Program will improve access to essential medications to vulnerable citizens and potentially save the state between $80 to $150 million in the first year alone.


“In Florida, we’ve led the nation in creating a program to lower prescription drug costs through their importation from Canada,” said Governor Ron DeSantis. “With the issuance of this new executive order directing the FDA to work with states, I expect no further delay in the approval of Florida’s plan to import safe and effective prescription drugs. While Big Pharma and federal bureaucracy have continued to stand in the way, it’s past time Florida taxpayers realized savings on these drugs.”


In May of this year, Governor Ron DeSantis toured the facility secured by Florida to warehouse drugs procured through this program and called on the Biden Administration and leadership at HHS to approve Florida’s SIP. Further, on June 1, 2021, Florida filed an Amicus brief in support of the HHS final rule implementing Section 804 of the Federal Food, Drug and Cosmetic Act, to facilitate the importation of prescription drugs.


Within 90 days of approval by the FDA, the Agency for Health Care Administration will finally be able to physically import prescriptions drugs, ensure customs inspections are complete and proper testing has taken place, and then fulfilling state agency orders. The state will begin by providing prescription drugs in a small number of drug classes which will include maintenance medications to help individuals that have chronic health conditions such as asthma, COPD, diabetes, HIV/AIDS and mental illness. These drugs will be for individuals who are under the care of the Agency for Persons with Disabilities (APD), Department of Children and Families (DCF), Department of Corrections (FDC), and Department of Health (DOH).



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