Drug Importation in Florida: An Overview
On November 23, 2020, Gov. Ron DeSantis announced that Florida had submitted its application to HHS for permission to run a Canadian importation program. (PDF)That application was amended several times, with the most current one dated April 7, 2023. (Read the current application) Older versions: Nov. 11, 2021 | Nov. 23, 2020
In August 2022, the State of Florida and Florida's Agency for Health Care Administration filed suit against the FDA and Department of Health and Human Services for delaying approval of its state importation program. October 2023 court filings show that the dialogue between Florida and the FDA about the program continues, but it's not clear when the government's final discussion will be made.
In April 2019, the Florida State Legislature passed HB19, a bill which requires Florida's Agency for Health Care Administration to establish a Canadian Prescription Drug program and an International Prescription Drug Importation Program.
Under the Medicare Modernization Act of 2003, Florida is required to submit a plan to HHS to import medicine from Canada that meets requirements set in that legislation.
How should we evaluate this program?
Official actions and statements
- April 29, 2019: Florida Legislature Passes HB19
- May 5, 2019: Florida Agency For Health Care Administration releases a Request For Information For Canadian Prescription Drug Importation Program (pdf | archived copy)
- May 6, 2019: Agency for Health Care Administration Secretary Mary Mayhew Issues Statement on the Passage of SB 1528/HB 19: Prescription Drug Importation Programs
- June 11, 2019: Governor Ron DeSantis Signs CS/HB 19: Prescription Drug Importation Programs
- June 13, 2019: The Drug Wholesale Distributor Advisory Council Discusses HB19 in Their June Meeting: Excerpt of Minutes
- June 18, 2019: Florida Board of Pharmacy Board Meeting discussing HB19
- August 23, 2019: Governor Ron DeSantis Submits Drug Importation Proposal to the U.S. Department of Health and Human Services. (Read the concept paper.)
- November 5, 2019: Florida's Senate Committee on Health Policy update on importation legislation. (Discussion begins at the 50 minute mark.)
- June 30, 2020: Florida issues an Invitation to Negotiate (ITN) to prospective importation vendors.
- November 23, 2020: Florida submits application to HHS.
- January 7, 2021: PHRMA, PSM and CAHC submit a citizen petition asking FDA not to authorize the proposal and to disclose the identities of Foreign Sellers for public comment.
- April 1, 2021: The American Pharmacists Association writes in support of the citizen petition.
- May 28, 2021: The Healthcare Distribution Alliance writes in support of the citizen petition.
- July 6, 2021: The U.S. Food and Drug Administration writes to say they have not yet resolved the issues raised in the citizen petition.
- August 31, 2022: The State of Florida and Florida's Agency for Health Care Administration filed suit against the FDA and Department of Health and Human Services for delaying approval of its state importation program.
- August 14, 2023: The FDA asked Florida to demonstrate supply chain safety and cost savings in its application.
- August 29, 2023: Florida's reply to the FDA's August 14 letter.
- September 18, 2023: PhRMA, PSM, and CAHC supplemented their January 2021 citizen petition to address Florida's updated proposal.
- HB 19: Text of the Bill | Florida House Staff Analysis
- May 5, 2019: Florida's Request For Information For Canadian Prescription Drug Importation Program (Archived copy)
- June 25, 2019: Responses to the Request for Information
- American Senior Alliance
- Epilepsy Association of the Big Bend (not provided to us in our FOIA request to Florida)
- Ernst and Young
- Health Distribution Alliance
- Maximus, Inc.
- Oncology Managers of Florida
- The Partnership for Safe Medicines
- State Hispanic Chamber of Commerce (not provided to us in our FOIA request to Florida)
- June 27, 2019: International Export Pharmacy Permit Application, DRAFT
- August 20, 2019: Canadian Prescription Drug Importation Concept Paper
- September 16, 2019: The Agency For Health Care Administration: Expenditures by Issue and Appropriation Category (Florida allocates $25.4 million for their importation program on pages 46-48)
- June 30, 2020: Invitation to Negotiate
- July 28, 2020: Addendum No. 1 to Invitation to Negotiate
- November 23, 2020: Preliminary Section 804 Importation Program (SIP) Proposal for the Importation of Prescription Drugs from Canada
- December 29, 2020: Contract between LifeScience Logistics and Florida's Agency for Health Care Administration
Background / resources
Just learning about the Florida foreign drug importation proposal? Start with some of these resources that outline the safety issues.
- "The Deadly Counterfeit Drug Trade Thrives in Florida" (May 2019 counterfeit incident summary)
- "10 Reasons Not to Import Drugs From Canada"
- Television advertisements:
- Florida Fails to Attract Bidders for Canada Prescription Drug Importation Program (October 23, 2020)
- Survey: Republicans Not Sold on Drug Importation, But Support Eliminating PBMs (June 12, 2019)
Op-eds from the Experts
In this editorial, which was published in the Palm Beach Post on April 22, 2019, Michelle Flowers writes about Florida’s history of black market cancer treatments and the danger importation poses to patients. Flowers is president of the Oncology Managers of Florida.
In this editorial, which was published in The Santa Cruz Sentinel on April 18, 2019, business columnist Jeffrey Scharf argues that importation of prescription drugs is a plan that is too good to be true.
The editorial board of the The Wall Street Journal published this editorial on April 15, 2019. In it, they write:
“The argument that drug importation threatens the integrity of the drug supply is often dismissed because pharmaceutical lobbyists make it. But keeping the drug supply free from contaminated or counterfeit products is not easy, and the World Health Organization has warned that 1 in 10 medical products in the developing world are phony. It isn’t clear who is liable if counterfeits are found in Florida, but you can bet it won’t be the politicians.”
In this editorial, which was published in The Gadsden Times on April 11, 2019, former FDA-OCI director George Karavetsos points out the real dangers of drug importation:
“Even today, Americans are being hurt and even dying because of counterfeit medications being imported into this country. Adding insult to injury, while some might point to Canada as being a safe source, counterfeit medications are transshipped through Canada from other countries in remote corners of the globe.”
This editorial by Dan Fucarino was published in Florida Politics on April 1, 2019. Mr Fucarino is the owner and a pharmacist at Carrollwood Compounding Center & Pharmacy.
“The monetary rewards of Canadian prescriptions are just not worth their safety risks,” he warns. “I urge Florida legislators to listen to health care experts on this issue rather than the understandable populist appeals and vote no on this dangerous legislation — and then get back to working on more productive ways to lower drug prices for Floridians. Thousands of Americans have been injured or killed by imported prescription drugs.”
Counterfeits coming from Canada have been a big issue in the Sunshine State. The FDA has identified dozens of counterfeit drugs coming into Florida from foreign pharmacies.
“Several other states have attempted to legalize drug importation, but all have failed to show that it’s safe or saves money. The federal government has determined multiple times that drug importation can’t be done safely. I hope, for the sake of Floridians, that state policymakers come to that same conclusion.”
In this March 5, 2019 editorial, published on the National Association of Manufacturers blog, Robyn Boerstling, the organization’s Vice President of Infrastructure, Innovation and Human Resources Policy, raises concerns about Florida’s drug importation proposal.