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.
The state released an Invitation to Negotiate to solicit importation vendors on June 30, 2020. The deadline for responses is September 29, 2020.
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
- 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.
- 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
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
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.
What can you do?
Reform domain name policy to stop COVID-19 and other healthcare scams
On May 8, 2020, PSM wrote Congressional leaders in the House and Senate urging them to require domain name sellers to suspend and lock websites that facilitate COVID-19 and other health fraud, and re-open registration information so that law enforcement can pursue criminals using websites to take advantage of the public.