The Issue
Millions of Americans rely on personal drug importation to afford needed medications.1 Evidence indicates that personal importation of non-controlled prescription drugs from properly verified sources—such as reputable licensed pharmacies operating in adequately regulated countries—can be done safely.2
Yet at International Mail Facilities (IMFs), FDA often destroys these medications based on technical classifications, such as “misbranding” or “unapproved” status, rather than evidence of diminished safety, thereby depriving patients of access to FDA-approved drugs or comparable foreign versions of those drugs.3
What’s Happening
Current enforcement priorities are misaligned with public health risk. FDA data show that the overwhelming majority of drugs stopped at IMFs are ordinary prescription medications for chronic conditions—not opioids or controlled substances. In 2022, about 53,000 drugs were detained by FDA and most of them were destroyed. None of the detained shipments involved fentanyl, and only a tiny fraction, 33 (0.06%) involved prescription opioids.4 At the same time, federal law expressly contemplates lawful personal importation and directs FDA to permit it where it does not present an “unreasonable risk” to patients.5
Approximate number of drug shipments detained by FDA in 2022, most of which were destroyed.
None of the detained shipments involved fentanyl, and only 33—approximately 0.06 percent—involved prescription opioids. At the same time, federal law expressly contemplates lawful personal importation and directs FDA to permit it where it does not present an “unreasonable risk” to patients.
Why the Current Approach Falls Short
Treating technical noncompliance as if it were evidence of danger diverts enforcement attention from products that pose genuine threats. A medicine can be deemed “unapproved” or “misbranded” under the Federal Food, Drug, and Cosmetic Act even where the product is authentic, properly manufactured, and comparable to a medicine lawfully sold in the United States.
FDA should distinguish between statutory noncompliance and actual risk. That distinction would permit more effective enforcement against counterfeit, contaminated, controlled, and otherwise dangerous products while reducing unnecessary harm to patients seeking affordable medicines.
Policy Recommendation
Congress should direct FDA to apply a risk-based, patient-centered approach at International Mail Facilities consistent with 21 U.S.C. § 384(j)(1).
- Prioritize enforcement against counterfeit, controlled, or dangerous drugs.
- Do not target personal-use quantities of non-controlled prescription drugs absent evidence of risk.
- Align enforcement with congressional intent and patient access needs.
- Clarify that technical noncompliance alone does not constitute a public health risk.
FDA should focus on dangerous drugs—not block safe, affordable medications Americans depend on.
References
- David Lim and Lauren Gardner, Individuals to drive drug imports for now, Politico-Prescription Pulse (Jan. 9, 2024), https://www.politico.com/newsletters/prescription-pulse/2024/01/09/individuals-to-drive-drug-imports-for now-00134439; Hong et al., Socioeconomic and Demographic Characteristics of US Adults Who Purchase Prescription Drugs From Other Countries, JAMA Network Open 3(6):e208968 (2020), https://doi.org/10.1001/jamanetworkopen.2020.8968, at 1.; H.S. Lalani et al., Strategies to Help Patients Navigate High Prescription Drug Costs, JAMA 332(20):1741–1749 (2024), https://doi.org/10.1001/jama.2024.17275 (recommending international online pharmacies as a last resort for patients lacking affordable domestic options).
- Roger Bate et al., American Enterprise Institute, Personal Medicine Importation: What Are the Risks, and How Can They Be Mitigated? (2019) (concluding that medicines purchased from credentialed foreign pharmacies are safe and that concerns about such sources are substantially overstated).
- Phil Galewitz, Asthma, Cancer, Erectile Drugs Sent From Abroad Make Up Most Confiscations, Despite Opioid Claims, CNN (Mar. 7, 2023), https://www.cnn.com/2023/03/07/health/fda-drug-shipments-khn-partner/index.html
- Id.
- See 21 U.S.C. §§ 384(j)(1); and 335a(b)(5); Prescription Drug Import Fairness Act of 2000, Pub. L. No. 106–387, § 745, 114 Stat. 1549, 1549A-40 (Oct. 28, 2000) (codified at 21 U.S.C. § 381(g)) (“Patients and their families sometimes have reason to import into the United States drugs that have been approved by the Food and Drug Administration…”).