top of page

A Prescription for Savings: Florida's Canadian Drug Importation Initiative

In today's RegAffairs Rx posting, we will discuss recent drug importation changes that have gained great lawmaker support and industry criticism. Whether it may prove itself to the overall benefit of patients will be seen in the coming years.


In a historic ruling, Florida was able to import some prescription medications from Canada on January 5, 2024, when the U.S. Food and Drug Administration (FDA) approved the state's drug importation program. This move, aligned with President Biden’s 2021 Executive Order 14036 to enhance competition in the American economy, aims to reduce drug costs while maintaining public health and safety. The program, established in 2020 under Section 804 of the Federal Food, Drug, and Cosmetic Act, sought to lower drug costs for American patients while protecting patient health outcomes. Based on the Florida Agency for Health Care Administration, this two-year authorization could save the state of Florida up to $150 million annually when it comes to importing drugs for conditions like diabetes, hepatitis C, HIV/AIDS, asthma, and chronic obstructive pulmonary disease.


To provide some regulatory context, 21 C.F.R. Part 251, which outlines the strict requirements for the importation program, contains Section 804. Key concepts include the medication receiving a compliance notice and drug identification number from the Health Products and Food Branch of Health Canada (HPFB), US labeling requirements, and NDA or ANDA requirements. Eligible medications do not include controlled substances, biologics, inhaled medications meant for surgery, IV or infused medications, intrathecal or intraocularly injected medications, REMS drugs, or drugs not defined as a product by the FDA.

From a patient perspective, the primary benefit of the program is the potential reduction in out-of-pocket costs for prescription drugs. This could particularly benefit those on fixed incomes or with chronic conditions requiring long-term medication. Improved access to affordable medicines could lead to improved adherence to treatment regimens, positively impacting overall health outcomes.


To implement this plan, Florida must fulfill additional FDA requirements, including pre-import requests for each drug and ensuring the drugs meet FDA labeling and quality standards.

The program's scope is limited: only particular state agency beneficiaries, like Medicaid recipients and residents in state facilities, will have access, and it excludes certain drug types, like biological products. Despite these limitations, the FDA's approval is a significant step in efforts to lower drug prices and could inspire other states to pursue similar strategies. This initiative aligns with the Biden Administration’s broader efforts to reduce prescription drug costs, as seen in the Inflation Reduction Act of 2022. In summary, the Inflation Reduction Act of 2022 includes provisions that introduce measures to reduce prescription drug costs, particularly for Medicare beneficiaries, through government negotiation of drug prices, rebates for price increases exceeding inflation, and a redesign of Medicare Part D to cap out-of-pocket costs and limit premium growth.


The American Pharmacists Association (APhA) has raised concerns about potential risks to patient safety and the integrity of the U.S. drug supply. The APhA warns that the program might introduce counterfeit drugs and create confusion in pharmacies, questioning its ability to reduce consumer costs significantly. Similarly, the Pharmaceutical Research and Manufacturers Association (PhRMA) has expressed serious concerns about the potential risks to public health. In addition, the state of Florida is also tasked with maintaining supply chain integrity and complying with drug recall procedures. This development reflects prescription drug regulation's complex landscape and the ongoing debate over the best methods to manage drug costs and safety. Further challenges include restrictions from the Canadian government concerning its drug supply and opposition from pharmaceutical industry groups like Pharmaceutical Research and Manufacturers of America (PhRMA). Industry lobbyists have argued that the decision does not ensure patient savings, burdens law enforcement, and increases the risk of counterfeit or adulterated pharmaceuticals.


Despite these hurdles, the FDA's approval marks a proactive step toward addressing high drug prices in the United States. Drug prices are a substantial concern for the US population, and plans to reduce costs have received bipartisan support. There is historical precedence behind this; there has been a decades-long effort to lower drug prices in the U.S., including legislative actions like the Medicine Equity and Drug Safety Act of 2000. This development represents a complex balance between cost reduction, drug safety, and efficacy, setting a precedent for other states. For regulatory affairs professionals, it underscores the importance of stringent regulatory compliance, supply chain management, and ongoing collaboration between state agencies and federal regulatory bodies. As the landscape of drug importation and distribution in the U.S. evolves, this decision will undoubtedly have far-reaching implications for drug pricing, patient safety (especially concerning the FD&C Act), and the pharmaceutical industry.

 

Sources

  1. AHCA head tells lawmakers a Canada drug import plan could save Florida $150 million. Health News Florida. Published October 21, 2021. Accessed January 15, 2024. https://health.wusf.usf.edu/health-news-florida/2021-10-21/ahca-head-tells-lawmakers-a-canada-drug-import-plan-could-save-florida-150-million

  2. Commissioner O of the. Importation Program under Section 804 of the FD&C Act. FDA. Published online January 5, 2024. Accessed January 15, 2024. https://www.fda.gov/about-fda/reports/importation-program-under-section-804-fdc-act

  3. FDA grants first-ever approval for a state to import Canadian drugs. MedicalEconomics. Published January 5, 2024. Accessed January 15, 2024. https://www.medicaleconomics.com/view/fda-grants-first-ever-approval-for-a-state-to-import-canadian-drugs

  4. ‌Cubanski J, Neuman T, Freed M. Explaining the Prescription Drug Provisions in the Inflation Reduction Act. KFF. Published September 22, 2022. https://www.kff.org/medicare/issue-brief/explaining-the-prescription-drug-provisions-in-the-inflation-reduction-act/

  5. ‌Florida’s importation plan puts patients in danger. phrma.org. Accessed January 15, 2024. https://phrma.org/Blog/Floridas-importation-plan-puts-patients-in-danger

  6. ‌APhA Press Releases. American Pharmacists Association. Accessed January 15, 2024. https://www.pharmacist.com/APhA-Press-Releases/fdas-decision-on-floridas-importation-program-jeopardizes-patient-safety

  7. Commissioner O of the. Importation Program under Section 804 of the FD&C Act. FDA. Published online January 5, 2024. https://www.fda.gov/about-fda/reports/importation-program-under-section-804-fdc-act

33 views1 comment

1 Comment


Guest
Jan 18

Greatly appreciate your brilliant observations; inspiring!


Like
bottom of page