Drug Importation in Florida: An Overview
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.
Governor De Santis signed the bill on June 11, 2019. The state is developing a plan to submit a Canadian importation plan to the Federal Health and Human Services Agency. Florida state regulators are simultaneously developing an RFP to solicit a vendor to run the importation program as well as licenses for international export wholesalers and pharmacies. (June 26, 2019)
How should we evaluate this program?
The program hasn't started yet, or even been designed, so there's no way to measure whether it saved money or kept patients safe, both promises made at the time of passage. However, the 2003 Medicare Modernization Act contains requirements for safety requirements built into any such program. PSM staff followed the debate in Florida and recorded promises made about safety and savings by the sponsors of the legislation.
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
- 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
- June 27, 2019: International Export Pharmacy Permit Application, DRAFT
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:
Op-eds from the Experts
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.