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. Attorneys for the FDA have stated they will render a decision on Florida's application no later than Oct. 31, 2023, making it unnecessary to have a trial in this case.
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.
- 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 analysis, which was published in Lexology on October 13, 2020, three global regulatory experts examine barriers to drug importation.
In this editorial, which was published in WBUR’s Cognoscenti on September 2, 2020, writer Sarah Ruth Bates explains why Canadian drug importation is too expensive and elaborate a solution to be effective.
In this August 14, 2020 editorial, Best Medicines Coalition chair John Adams explains why Canadian importation will not lower U.S. medicine prices—and why the “concept of cheap drugs from Canada has never been anything more than a political hallucination.”
This editorial by Peter J. Pitts was published in The Times Weekly on March 3, 2020. Mr. Pitts is president of the Center for Medicine in the Public Interest and a former FDA associate commissioner. Keep Canadian drugs out of U.S. medicine cabinets The Trump administration recently proposed two rules that would allow states, pharmacies,…
In this editorial in The Globe and Mail, Ujjal Dosanjh, formerly a federal minister of health and a premier of British Columbia, explains that drug manufacturers have no incentive to sell Canadian provinces more medicine to fill the needs of U.S. residents. Importation will lead to drug shortages in Canada and counterfeit drug trafficking to the U.S.
This editorial by David C. Rosenbaum and Dara Jospé was published in the Financial Post on January 16, 2020. Rosenbaum is a partner of the law firm Fasken. Jospé is an associate for the same company.
This editorial by Dr. Kristina M. L. Acri née Lybecker was published in IP Watchdog on January 2, 2020. Dr. Acri is an Associate Professor of Economics at Colorado College in Colorado Springs, and Chair of the Department of Economics and Business.
This editorial by Dr. Kenneth E. Thorpe was published in Town Hall on October 8, 2019. Dr. Thorpe is a professor of health policy at Emory University and chairman of the Partnership to Fight Chronic Disease.
This editorial by C. Michael White was published in The Conversation on September 27, 2019. White is a professor and head of the Department of Pharmacy Practice for the University of Connecticut.
This editorial by Peter J. Pitts was published in The Washington Times on September 11, 2019. Mr. Pitts is president of the Center for Medicine in the Public Interest and a former FDA associate commissioner.