What Does the “Most Favored Nation” Executive Order Mean for Personal Use Imports?

We are still parsing through the May 12 Executive Order (EO), “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients” and impacts this may have on the pharmaceutical industry.  We’ve blogged about Most-Favored-Nation (MFN) drug pricing and how the new EO goes well beyond the 2020 order and questions we have.  Of interest to these bloggers is the provision that deals with personal use importation.  (We note our departure from more light-hearted content and absence of musical references.  Please bear with us.)

Section 5 of the May 12 EO states that within 30 days, HHS will communicate MFN price targets to pharmaceutical manufacturers to bring prices for patients in line with “comparably developed nations.” If significant progress toward MFN is not made, the EO seeks to permit personal importation of less expensive drugs from foreign countries.  It provides that

the Secretary shall consider certification to the Congress that importation under section 804(j) of the Federal Food, Drug, and Cosmetic Act (FDCA) will pose no additional risk to the public’s health and safety and result in a significant reduction in the cost of prescription drugs to the American consumer; and if the Secretary so certifies, then the Commissioner of Food and Drugs shall take action under section 804(j)(2)(B) of the FDCA to describe circumstances under which waivers will be consistently granted to import prescription drugs on a case-by-case basis from developed nations with low-cost prescription drugs

We’ve seen this type of language in an EO before and to date, we still do not have a legal pathway for the personal importation of unapproved drugs.  Given that the provision in the May 12 EO may be a rehash of what occurred in 2020, we thought it would be helpful to provide a bit of history and background on personal importations.

As an initial matter, the Federal Food, Drug, and Cosmetic Act (FDC Act) precludes the importation of unapproved prescription drug products, including versions of FDA-approved drugs intended for distribution in foreign markets like the EU. As documented in a Congressional Research Service Report, FDA has taken the position that even a foreign-made drug that has the same active ingredient and is made by the same manufacturer of an FDA-approved drug is “highly unlikely” to “meet all of the requirements in the [FDC Act] for approval” such that it may be eligible for importation into the U.S.  Instead, FDA’s webpage on Personal Importation provides that “[i]f a drug is approved for use in another country but is an unapproved new drug in the U.S. it is illegal to import.”

Congress afforded FDA discretion to waive the prohibition on importation of unapproved prescription drugs where importation is for personal use and the drug does not appear to present an unreasonable risk to the individual.  FDC Act § 804(j)(1), (2).  FDA may issue such waivers by regulation or on a case-by-case basis.  Congress also directed FDA to issue guidance describing circumstances under which FDA consistently would grant such waivers.  This provision is effective only upon certification to Congress under FDC Act § 804(l) that the implementation of a waiver system would “pose no additional risk to the public’s health and safety” and would “result in a significant reduction in the cost of covered products to the American consumer.”   Absent such a certification, the provisions of FDC Act § 804 legally are not in effect.

Note – This is what the May 12 Executive Order is requiring – that HHS consider certifying to Congress that personal imports will pose no additional risk to the public’s health and safety.

The May 12 EO regarding personal importation is similar in this regard to the EO from 2020.  President Trump, at that time, directed HHS and FDA to facilitate “grants to individuals of waivers of the prohibition of importation of prescription drugs,” subject to the caveat that “such importation poses no additional risk to public safety and results in lower costs to American patients, pursuant to section 804(j)(2) of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 384(j)(2).”  Rather than obviate the need for a certification to that effect, the EO mandates that such waivers are granted only as “consistent with applicable law,” which, again, requires a certification under 804(l) for 804(j) to be in effect.  While then-Secretary of Health and Human Services, Alex Azar, made a certification to Congress about other provisions in §804 of the FDC Act (namely, importations from Canada as described in FDC Act §§ 804(b)-(h)) this certification expressly excluded § 804(j).  Letter from Alex Azar II to Hon. Kevin McCarthy (Sept. 23, 2020).  Specifically, the certification letter states that “[t]he personal importation provisions of section 804(j) of the FD&C Act are not being implemented . . . and thus section 804(j) is not currently in effect.”   Secretary Azar goes on to say “[a]ny implementation of section 804(j) . . . would occur through a separate certification.”  No such separate certification has been issued to date.

Due to the risks involved in personal importation, FDA specifically refused to implement a formal personal importation policy.  See Proposed Rule, Importation of Prescription Drugs, 84 Fed. Reg. 70,796, 70,800 (Dec. 23, 2019).  In a Proposed Rule implementing provisions relating to the importation of certain prescription drugs from Canada, FDA explained that it “is not proposing to implement the personal importation provisions in section 804(j)” because imported medications “pose significant challenges for FDA and its ability to adequately safeguard the quality and safety of drugs taken by U.S. consumers.”  FDA recognized that “there are pharmacy websites that operate legally and offer convenience, privacy, and safeguards for purchasing medicines,” but there are many that fail to adhere to safeguards followed by pharmacies licensed in the U.S.  Accordingly, FDA did “not implement personal importation provisions under section 804(j) of the FD&C Act” when it adopted rules implementing other provisions in section 804 of the FDC Act.  And while the Final Rule acknowledges that EO 13938 directs FDA and HHS to facilitate waivers under section 804(j) of the FDC Act, FDA maintained that it was “not implementing the personal importation provisions in section 804(j) of the FD&C Act through this rulemaking.”  Final Rule, Importation of Prescription Drugs, 85 Fed. Reg. 62,094, 62,097 (Oct. 1, 2020).

To date, neither FDA nor HHS has issued a guidance document describing circumstances in which the agencies will consistently grant waivers, as required under FDC Act § 804(j)(2).  FDA has, however, set forth on its website a policy for “personal importation.”  Under that policy, FDA would permit imports of Over-the-Counter treatment and limited imports of prescription drug products for personal use.   https://www.fda.gov/industry/import-basics/personal-importation.  With respect to prescription drug products, FDA will allow personal imports if the product is for a serious condition for which effective treatment may not be available domestically; there is no known commercialization or promotion of the product to persons in the U.S.; the product does not represent an unreasonable risk; the consumer affirms in writing that the product is for personal use; and the quantity is not more than a three-month supply.

It’s hard to read the tea leaves on the future of personal imports.  FDA has previously issued Warning Letters to entities facilitating the importation of foreign drugs and maintains an active import alert regarding these products, last updated on April 14, 2025.  That import alert notes the following:

FDA has observed foreign unapproved prescription drugs offered for sale in the United States by unsafe online pharmacies which poses a significant public health concern. Unapproved prescription drugs present serious safety and effectiveness concerns. Moreover, FDA-approved versions of these drugs are often available in the United States. Therefore, this import alert is intended to identify known distributors, including online pharmacies, of unapproved prescription drugs to U.S. consumers.

There are inherent risks to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight. Drugs that have circumvented regulatory safeguards may be contaminated, contain varying amounts of active ingredients, or contain different ingredients altogether. In examining imported drugs sent through the mail, FDA has identified unapproved drugs, counterfeit drugs, improperly labeled drugs, drugs that failed to meet special storage conditions, and drugs that require supervision of a practitioner licensed by law to administer them.

It’s not clear whether the May 12 EO will lead to a certification to Congress that personal imports pose no additional risk to the public’s health and safety.  That position is at odds with FDA’s historical stance.  Given the unprecedented turnover within FDA and new leadership, however, FDA’s historical stance may not be relevant.