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
This editorial by Liam Sigaud was published by Inside Sources on August 27, 2019. Mr. Sigaud is an economic policy researcher who writes for the American Consumer Institute, a nonprofit educational and research organization.
This editorial by Dana McDougall was published in The Waterloo Cedar Falls Courier on August 26, 2019. Mr. McDougall, Pharm.D., BCPS, is a pharmacist with the Covenant Cancer Treatment Center in Waterloo, Iowa.
This editorial by Perry Thurston Jr. was published in Florida Politics on July 16, 2019. In it, State Senator Thurston explains that state-implemented drug importation will not bring any medication cost savings to Floridians.
This editorial by Adam Fein and Dirk Rodgers was published in Stat News on July 11, 2019. In it, Fein and Rodgers warn that plans by states to create drug importation programs will open new pathways for counterfeit drugs to enter the U.S. drug supply chain…
In this editorial, which was published by the Fraser Institute on June 13, 2019, economist Dr. Kristina Acri argues against importation, concluding: “Diverting drugs meant for Canadian patients to the U.S. through state importation schemes will create shortages for Canadian patients and increase pressure on potentially unscrupulous suppliers to source drugs from wherever they can, opening the door to counterfeiters.”
This editorial by Guy Anthony was published in the Orlando Sentinel on June 12, 2019. Anthony, President and CEO of Black, Gifted & Whole, a nonprofit focused on issues surrounding black, queer men, warns that drug importation will open up “a market for dangerous, counterfeit drugs” that will make it harder for people to live with HIV and other complex illnesses.
In this editorial published on April 26, 2019, Douglas Holtz-Eakin, economist and President of American Action Forum, questions economic truths about drug importation:
“Drug reimportation has long been the fool’s gold of health policy, and the Florida bill is no different. It flunks a basic policy analysis. But most amazing, it is drafted to raise hope, but not actually help Floridians.”
In this piece published in the Washington Free Beacon on April 25, 2019, staff writer Charles Fain Lehman explores issues around Florida’s drug importation proposal. “Critics,” he notes, “fear that the actual realities of regulatory oversight—especially in the hand of an as-yet-unnamed private vendor—will simply be too challenging to manage responsibly.”
In this piece, which was published on the ABC affiliate WJLA’s website on April 25, 2019, political analyst Boris Epshteyn explains that “this is a risky plan that will make it difficult to ensure that Floridians are receiving real and safe medicine.”
In this piece, which was published in the Inside Sources on April 22, 2019, Michael Graham reviews the case against drug importation: “As Scott Gottlieb said in 2016 before becoming President Trump’s FDA chief…’There are simply too many channels for fake drugs to enter any importation scheme to forgo some meaningful controls.’”