FDA should heed Congress’s declaration to allow personal importation of lower-cost medications.
The U.S. Congress does not often declare how a federal agency should exercise enforcement discretion. When it does, particularly with respect to access to affordable prescription drugs for millions of Americans, its statutory language deserves careful attention. Section 804(j)(1) of the Federal Food, Drug, and Cosmetic Act (FDCA) is one such provision.
In 2003, against the backdrop of a growing number of Americans importing lower-cost prescription drugs for personal use—“personal importation”—Congress added section 804(j)(1) to the FDCA. The provision declares that the Secretary of Health and Human Services should exercise enforcement discretion to permit otherwise non-compliant drug importation when it is “clearly for personal use” and does not “appear to present an unreasonable risk to the individual.”
The U.S. Food and Drug Administration (FDA) does not view personal importation as categorically unlawful. It states that in most circumstances, personal importation is unlawful because drugs sold abroad “often have not been approved by FDA.” But when FDA confronts a personal prescription-drug importation that does appear to violate the FDCA, what legal significance should be given to Congress’s declaration in section 804(j)(1) asserting how the Secretary should exercise enforcement discretion?
FDA has maintained a Personal Importation Policy (PIP) for decades, predating the enactment of section 804(j)(1). Unlike section 804(j)(1), the PIP is neither law nor regulation but an internal policy articulating how FDA personnel should exercise enforcement discretion regarding personal importation that violates the FDCA. According to FDA, the PIP generally covers individuals seeking “unapproved” drugs, not lower-cost versions of prescription drugs commercially available through U.S. pharmacies. Accordingly, while still a fraction of the total imported, when FDA examines personal prescription-drug importations, it generally refuses admission and ultimately destroys the medications
Whether FDA’s enforcement practices give meaningful effect to Congress’s declaration in Section 804(j)(1) turns on two related questions: first, whether section 804(j)(1) has independent legal force; and second, if it does, whether FDA’s PIP faithfully implements that directive.
The answers to those questions have serious consequences. A nationally representative study estimated that approximately 2.3 million Americans with prescriptions obtain drugs from outside the United States each year to save money. FDA justifies increased enforcement as necessary to intercept dangerous opioid drugs, especially fentanyl.
In 2022, FDA personnel examined nearly 53,000 imported drug shipments; only 33 contained opioids, and none contained fentanyl. Most were destroyed anyway. The agency’s enforcement data show that almost all intercepted shipments involve non-controlled prescription medications, including drugs used to treat chronic diseases such as asthma, diabetes, cancer, HIV, thyroid disease, high cholesterol, and other serious medical conditions. More recent FDA data indicate that the number of drug products refused at FDA inspection have increased to about 72,000, with most destroyed, over the last one-year span FDA measured.
The answer to the threshold question begins with the structure of section 804 in its entirety before turning to the judicial decisions that later construed it.
Section 804 establishes two distinct importation frameworks: a wholesale importation program, set forth principally in subsections (b) through (h) and separate provisions governing personal importation—subsection (j). Added to the FDCA in 2003 as part of the Medicare Prescription Drug, Improvement, and Modernization Act, subsection (j) established three distinct provisions serving separate functions: (j)(1), (j)(2), and (j)(3). Subsection (j)(1) declares how the Secretary should exercise enforcement discretion, (j)(2) authorizes waivers for personal importation generally, and (j)(3) creates a separate waiver program limited to personal imports from Canada. The geographic limitation in subsection (j)(3), absent from (j)(1) and (j)(2), further reinforces that Congress assigned each paragraph a distinct function.
The legislative history corroborates that statutory interpretation. The U.S. House of Representatives passed its bill with only a Canada-specific waiver provision, but the U.S. Senate instead adopted the amendments proposed by Senator Byron Dorgan (D-N.D.), dividing personal importation into the three provisions—(j)(1), (j)(2), and (j)(3)—that ultimately became subsection 804(j). Contemporary Congressional Research Service analysis likewise explained that the Senate bill “would let the Secretary grant waivers for personal-use imports from any source” and that the bill “urges using discretion in enforcing the personal-use import policy.”
The courts, however, have not always construed section 804(j) consistent with that design. Subsequent judicial decisions instead misconstrued subsection 804(j)(1) in conjunction with the neighboring provisions (j)(2) and (j)(3), rather than as an independent congressional declaration regarding enforcement discretion. In Vermont v. Leavitt (2005), a federal trial court held that section 804(l)’s certification requirement—under which the Secretary of Health and Human Services needed to certify certain conditions before section 804 would become effective—applied to the personal importation provisions, not just the wholesale importation provisions at issue in the case.
Notably, however, when the Secretary finally issued that subsection (l) certification in 2020, he applied it only to the wholesale importation provisions found in (b) through (h), not the personal importation provisions in subsection (j). Moreover, the structure of section 804 does not make the subsection (l) applicable to the personal importation provisions. Subsection (l) consists of two intertwined provisions: “(l)(1) Commencement of Program” and “(l)(2) Termination of Program.” Read together, they govern the same regulatory “program.” Critically, (l)(2) authorizes termination of regulations governing wholesale importation under subsection (b), not regulations of personal importations under subsection (j). Had Congress intended the subsection (l) to govern both wholesale and personal importation, the termination provision would have addressed both.
The statute’s differing safety standards for wholesale and personal importation reinforce that conclusion. Congress required the Secretary to certify that wholesale importation from Canada would pose “no additional risk” to the public’s health and safety. By contrast, section 804(j)(1) declares that the Secretary “should” permit personal importation from any country when it “does not appear to present an unreasonable risk to the individual.” Those are different standards to address distinct supply channels.
Even if subsection (l) does not govern personal importation, Cook v. FDA presented a different challenge to enforcement discretion under section 804(j)(1) where the court stated that a “waiver” issued by the Secretary was first required.
In Cook, death-row inmates challenged FDA’s decision to allow the importation of sodium thiopental for use in lethal injections, arguing that a different statutory provision required FDA to refuse importation of the drug because it was an “unapproved” drug. In Cook, FDA argued that under section 804(j)(1), the agency has discretion to ignore that requirement to allow the importation of drugs that are “clearly for personal use.” The U.S. Court of Appeals for the D.C. Circuit rejected that argument, reasoning that Congress would have had no reason to enact section 804(j)(2)’s express waiver authority if FDA already possessed the enforcement discretion it claimed under section 804(j)(1).
The court in Cook was right to reject FDA’s invocation of section 804(j)(1). Sodium thiopental imported for use in executions fell well outside of the circumstances Congress described in section 804(j)(1). The drug was not imported by patients for personal use and plainly presented an unreasonable risk to the individual. But in doing so, the court in Cook conjoined two independent provisions that Congress had deliberately separated. Section 804(j)(1) concerns the Secretary’s exercise of enforcement discretion. Section 804(j)(2) authorizes the Secretary to grant waivers. Those provisions serve different purposes. A waiver prospectively authorizes conduct that would otherwise violate the FDCA. Enforcement discretion, by contrast, concerns FDA’s decision whether to act against a particular non-compliant import. Nothing in the statute mandates the prior issuance of a waiver for the Secretary to exercise enforcement discretion.
Cook’s reading, that Congress intended the newly enacted waiver authority to serve as the exclusive means by which FDA could permit personal importation, is also hard to reconcile with the contemporaneous circumstances giving rise to the new law. Congress enacted section 804 when millions of Americans were already importing lower-cost prescription drugs for personal use pursuant to FDA’s longstanding exercise of enforcement discretion. A more straightforward reading is that section 804(j)(1) codified Congress’s support of that practice.
Personal importation, when patients use verified international pharmacies that require valid prescriptions, is considered a lifeline of affordable medicine by consumer advocates and health policy experts. However, FDA continues to destroy more personally imported medication each year without assessing if the products represent an “unreasonable risk.” Instead, FDA should administer the PIP in a manner that gives meaningful effect to Congress’s declaration in section 804(j)(1). Even better, the Secretary should implement the separate waiver authority Congress enacted in section 804(j)(2), creating a more trusted and transparent process through which patients may lawfully obtain lower-cost prescription drugs under appropriate safeguards.
