Can FDA's Florida Drug Import Program Cut Costs and Boost Medication Access?

A patient’s ability to afford medications remains an integral factor in determining if a patient will get a prescription filled or remain adherent to medication. Various efforts, such as patient savings programs sponsored by multiple drug manufacturers for eligible patients and coupon saving programs, have helped patients. However, there are some patients who cannot afford or struggle with paying for their medications.

The FDA released a press release on January 5, 2023, stating it authorized Florida’s Agency for Health Care Administration’s drug importation program under section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which is the initial step on this pathway toward Florida enabling the importation of certain prescription drugs from Canada.¹ This plan is the first in the US to improve patient access to more affordable prescription medications.

The FDA press release states, “Through this pathway, the FDA may authorize section 804 importation program (SIP) proposals from states or Indian tribes to import certain prescription drugs from Canada if the SIP will significantly reduce the cost to the American consumer without imposing additional risk to public health and safety.”¹

The FDA authorized Floridia’s SIP for 2 years from the date the FDA was informed of the first shipment of prescription drugs imported. The FDA also specifies Florida’s Agency for Health Care Administration must comply with the following requirements before medications can be imported:

• Provide added drug-specific information for the FDA's review and approval.
• Make certain that the prescription medications that Florida requests to import have been assessed for, among other things, legitimacy and compliance with the FDA-approved drugs’ specifications and standards.
• Relabel the drugs to be in accordance with the FDA-approved labeling.¹

The FDA also indicates that a quarterly report involving information about the imported drugs, cost savings, and any potential safety and quality concerns must be submitted by the Florida Agency for Health Care Administration to the FDA for approval.¹

FDA Commissioner Robert M. Califf, MD, stated, “The FDA is committed to working with states and Indian tribes that seek to develop successful section 804 importation proposals. These proposals must demonstrate the programs would result in significant cost savings to consumers without adding risk of exposure to unsafe or ineffective drugs.”¹

The American Society of Health-System Pharmacists’ Tom Kraus, ASHP vice president of government relations, stated, “This drug importation proposal is not a real solution. The Canadian market cannot supply anywhere close to the amount of medication needed to bring down US drug prices. Patients also need to know that this approach undermines the protections that pharmacists and physicians rely on to keep our drug supply safe. We need politicians to focus on real solutions like ending pharmacy benefit manager rebates that undermine competition and discourage use of lower-cost medications, and allowing pharmacists to substitute clinically equivalent biologic medications like they do for generic small molecule drugs.”²

The press release also indicated that the ASHP has long opposed states importing prescription drugs because, “it has the potential to disrupt the pharmacist-patient relationship, particularly for patients with complex medication regimens, and because it is not a meaningful response to drug pricing.”² The ASHP also added that its organization will continue to monitor the program in Florida as it is implemented and provide updates as they become available.

In another press release, the American Pharmacists Association (APhA) addressing this new FDA mandate stated, “The American Pharmacists Association (APhA) is dismayed that FDA gave the green light to Florida to import prescription drugs from Canada, jeopardizing patient safety and compromising our nation’s drug supply. FDA’s authorization of the State of Florida’s Section 804 Importation Program does not address significant concerns that create vulnerabilities for the introduction of counterfeit and unsafe drugs into the marketplace.”³

Conclusion

Findings from a report published in 2022 revealed that Americans pay the highest amount for prescription drugs than the countries that were manufacturing them.⁴ Another survey conducted in 2023 revealed that 20% of those surveyed indicated that the high costs of medication prevented them from adhering to medications, and an estimated 9% had to forgo or budget basic necessities to afford their medications.⁵

The impact of Florida’s new SIP program remains to be seen. Hopefully, implementing the FDA requirements to ensure safety and compliance with current FDA-approved standards may aid in this program's success, but it is still too early to tell. The pros and cons are an issue of great debate. Due to their drug expertise, pharmacists are always dedicated to ensuring the safe and efficacious use of drugs and providing their patients with the best quality of care. Pharmacists' viewpoints and expertise should be considered and valued as the program is implemented.

References

1. FDA authorizes Florida’s Drug Importation Program. News release. FDA. January 5, 2024. Accessed January 8, 2024. https://www.fda.gov/news-events/press-announcements/fda-authorizes-floridas-drug-importation-program
2. ASHP Weighs in on FDA decision to allow medication imports from Canada. ASHP News Center. Published January 5, 2024. Accessed January 8, 2024. https://news.ashp.org/News/ashp-news/2024/01/05/ashp-weighs-in-on-fda-approval-of-florida-medication-importation-plan
3. FDA’s decision on Florida’s importation program jeopardizes patient safety. News release. APhA. January 5, 2024. Accessed January 8, 2024. https://www.pharmacist.com/APhA-Press-Releases/fdas-decision-on-floridas-importation-program-jeopardizes-patient-safety
4. FDA gives the OK for Florida to import drugs from Canada. Biospace. Published January 8, 2024. Accessed January 8, 2024. https://www.biospace.com/article/fda-gives-the-ok-for-florida-to-import-drugs-from-canada/
5. Dusetzina SB, Besaw RJ, Whitmore CC, et al. Cost-related medication nonadherence and desire for medication cost information among adults aged 65 years and older in the US in 2022. JAMA Netw Open. 2023;6(5): e2314211. doi:10.1001/jamanetworkopen.2023.14211