FDA Approval Makes Florida First State to Import Drugs From Canada

In a pivotal move that could lower drug prices for the American consumer, the FDA has given Florida the okay to begin importing drugs in bulk from Canada.¹ The state estimates that its drug importation program could save taxpayers up to $180 million annually.²

What’s the Issue?

Soaring drug costs have placed financial strain on Americans for decades, leading some to choose between being able to afford prescribed medications and other necessities like rent or groceries. Florida’s plan will help lower drug prices for Americans, an issue championed by key players like President Joe Biden and former President Donald Trump.²

• Under the Federal Food, Drug and Cosmetic Act, Florida will be allowed to purchase and distribute Canadian wholesale medications to participants of the state’s Medicaid program, government clinics, and prisons.²
• The program will be authorized for 2 years from the date of the first shipment of imported drugs.¹
• Terms of the FDA approval require that Florida’s Agency for Health Care Administration submit quarterly reports to the FDA detailing information about imported drugs, financial data, and any shipment issues, for the duration of the program.¹

Why it Matters

The struggles faced by Americans who cannot afford their prescriptions have been consistently demonstrated by past literature. The FDA’s approval of Florida’s program will help mitigate the financial burden placed on patients and the larger health care system.

• In 2021, the CDC reported that 8.2% of adults between the ages of 18 and 64 who took prescription medication in the past 12 months stopped their prescribed regimen due to high costs.³
• Cost-related nonadherence is linked to adverse patient outcomes, hospitalizations, and billions of dollars spent on unnecessary health care costs.⁴
• The financial burden of out-of-pocket prescription prices has weighed disproportionately on low-income communities: Hispanics and Blacks, who have been shown to be more likely to be paid lower wages than Whites, must sacrifice a larger percentage of their earnings to afford necessary medications.⁵

In-Depth Insights

The FDA approval has stirred up a mixed response from the public.

• Following suit of Florida, at least 7 states have established laws that would allow them to implement similar state drug importation programs, many of which have already received attention from the FDA.²
• On behalf of the approval, the Pharmaceutical Research and Manufacturers of America issued a statement labeling the importation of unapproved medicines as “reckless.”⁶
• Some Canadian officials have expressed opposition to the move, echoing a briefing from government officials written in 2019 that said the country “does not support actions that could adversely affect the supply of prescription drugs in Canada and potentially raise costs of prescription drugs for Canadians.”⁷

Expert Commentary

• “The FDA is committed to working with states and Indian tribes that seek to develop successful section 804 importation proposals,” said Robert M. Califf, MD, FDA commissioner, referencing the feasibility of similar programs proposed by other states.¹ “These proposals must demonstrate the programs would result in significant cost savings to consumers without adding risk of exposure to unsafe or ineffective drugs.”
• “We’re creating a system with importers and vendors that we as a state will import drugs from Canada, relabel them, and get them to Florida and send them out through various state programs that way,” said Jason Weida, secretary of Florida’s Agency for Health Care Administration.² “That guarantees safety. That guarantees cost savings.”

Extra Reading

For more on this issue, check out these articles.

• https://www.fda.gov/news-events/press-announcements/fda-authorizes-floridas-drug-importation-program?Fri,%2005%20Jan%202024%2009:15:13%20EST (FDA)
• https://www.cnn.com/2024/01/05/politics/florida-canada-drug-imports-fda/index.html (CNN)

References

1. FDA authorizes Florida’s drug importation program. News release. FDA. January 5, 2024. Accessed January 5, 2024. https://www.fda.gov/news-events/press-announcements/fda-authorizes-floridas-drug-importation-program?Fri,%2005%20Jan%202024%2009:15:13%20EST

2. Luhby, T. FDA approves first state request to import drugs from Canada. News release. CNNPolitics. January 5, 2024. Accessed January 5, 2024. https://www.cnn.com/2024/01/05/politics/florida-canada-drug-imports-fda/index.html

3. Laryssa, M, Cohen, AR. Characteristics of adults aged 18-64 who did not take medication as prescribed to reduce costs: United States 2021. Data brief. CDC. June 2, 2023. Accessed January 5, 2024. https://stacks.cdc.gov/view/cdc/127680

4. Rohatgi KW, Humble S, McQueen A, et al. Medication adherence and characteristics of patients who spend less on basic needs to afford medications. J Am Board Fam Med. 2021;34(3):561-570. doi:10.3122/jabfm.2021.03.200361

5. Kogut SJ. Racial disparities in medication use: Imperatives for managed care pharmacy. J Manag Care Spec Pharm. 2020;26(11):1468-1474. doi:10.18553/jmcp.2020.26.11.1468

6. PhRMA statement on FDA authorizing Florida’s importation plan. News release. PhRMA. January 5, 2024. Accessed January 5, 2024. https://www.phrma.org/resource-center/Topics/Access-to-Medicines/PhRMA-Statement-on-FDA-Authorizing-Floridas-Importation-Plan

7. Martell, A. Exclusive: Canada warns U.S. against drug import plans, citing shortage concerns. News release. Reuters. July 18, 2019. Accessed January 5, 2024. https://www.reuters.com/article/idUSKCN1UD2LJ/