ADVI Instant: FDA Authorizes Florida’s Drug Importation Program

On January 5, 2024, the Food and Drug Administration (FDA) announced that it authorized Florida’s drug importation program under section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), allowing the state to move forward with its plan to import prescription drugs from Canada.

The announcement follows a July 2021 executive order directing the FDA to work with states to develop plans for drug importation and a federal court’s ruling in February 2023 to dismiss a lawsuit against a 2020 final rule related to importation. 

While Florida is the first state to receive approval to import prescription drugs from Canada, several others have either submitted an authorization request or are planning to do so.

Background

Current law allows for the importation of certain drugs in defined, limited circumstances, and only if the Secretary of HHS certifies that importation poses no threat to the health and safety of the American public and will result in significant cost savings to the American consumer. In September 2020, the Trump Administration issued a final rule and final FDA guidance, creating new pathways for the safe importation of drugs from Canada and other countries. After the rule was finalized, PhRMA and other parties filed a lawsuit challenging the rule based on safety and other concerns.

In May 2021, the Biden Administration sought to dismiss this lawsuit, arguing that plaintiffs cannot show the final rule or the certification by the HHS Secretary has harmed them. Because, at the time, FDA had not authorized any state importation plan under the final rule, and because there is no timeline for authorization, the Administration asserted that “possible future injuries to Plaintiffs’ members are overly speculative and not imminent.” The federal court granted the motion to dismiss in February 2023. 

The Biden Administration’s position in this lawsuit opened the door for states to move forward with drug importation plans. In a July 2021 executive order, President Biden directed the FDA to work with states to create plans to import prescription drugs from Canada.

After the 2021 executive order, the FDA developed a pathway under section 804 of the FD&C Act that allows importation of certain prescription drugs from Canada. To legally import prescription drugs from Canada, states must submit a Section 804 Importation Program, or SIP, application. In 2019, Florida became the first state to submit an SIP application with the FDA. Eight other states — Colorado, Maine, New Hampshire, New Mexico, North Dakota, Texas, Vermont and Wisconsin — have laws allowing for a state drug importation program, and many are seeking, or planning to seek, FDA approval.

Announcement

On January 5, 2023, the FDA announced that it authorized Florida’s drug importation program under section 804 of the FD&C Act. While further action is needed, Florida may now move forward with its plan to import prescription drugs from Canada.

Florida’s SIP is approved for 2 years, with the timeline beginning on the date FDA is notified of the first shipment of drugs to be imported. The FDA may extend the authorization period in two-year increments moving forward.

Before drugs can be imported, Florida must:

• Submit a Pre-Import Request to FDA for individual drugs it plans to import.
• Conduct testing to ensure product authenticity, quality, and compliance with U.S. standards. This testing may be done by Florida or the manufacturer of the prescription drugs.
• Re-label the prescription drugs to be consistent with FDA-approved labeling.

Florida must submit quarterly reports moving forward which include information on:

• Imported prescription drugs
• Cost savings
• Potential safety and quality issues

While Florida has not yet specified which drugs it will seek to import, the state has previously indicated it may focus on medicines that treat HIV, AIDS, diabetes, hepatitis C, and psychiatric conditions.

Stakeholder Response

Shortly after the announcement, the Pharmaceutical Research and Manufacturers of America (PhRMA) released a statement expressing concern with FDA’s decision. PhRMA previously sued over the 2020 final rule allowing importation of prescription drugs from Canada, and indicated in press statements on January 5, 2024, that it may do so again.

ADVI will continue monitoring developments and the next steps. This is a delayed release. ADVI Instant content is distributed in real-time for retainer clients. Get in touch to learn more about how we can support your commercialization, market access, and policy needs.

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Allison Schneider, MHA
Director