We’re nonetheless parsing by the Could 12 Government Order (EO), “Delivering Most-Favored-Nation Prescription Drug Pricing to American Sufferers” and impacts this may increasingly have on the pharmaceutical business. We’ve blogged about Most-Favored-Nation (MFN) drug pricing and the way the brand new EO goes nicely past the 2020 order and questions we have now. Of curiosity to those bloggers is the availability that offers with private use importation. (We notice our departure from extra light-hearted content material and absence of musical references. Please bear with us.)
Part 5 of the Could 12 EO states that inside 30 days, HHS will talk MFN worth targets to pharmaceutical producers to carry costs for sufferers consistent with “comparably developed nations.” If important progress towards MFN shouldn’t be made, the EO seeks to allow private importation of inexpensive medication from overseas international locations. It supplies that
the Secretary shall contemplate certification to the Congress that importation underneath part 804(j) of the Federal Meals, Drug, and Beauty Act (FDCA) will pose no further threat to the general public’s well being and security and lead to a major discount in the price of prescribed drugs to the American client; and if the Secretary so certifies, then the Commissioner of Meals and Medication shall take motion underneath part 804(j)(2)(B) of the FDCA to explain circumstances underneath which waivers shall be constantly granted to import prescribed drugs on a case-by-case foundation from developed nations with low-cost prescribed drugs
We’ve seen such a language in an EO earlier than and up to now, we nonetheless would not have a authorized pathway for the non-public importation of unapproved medication. On condition that the availability within the Could 12 EO could also be a rehash of what occurred in 2020, we thought it might be useful to offer a little bit of historical past and background on private importations.
As an preliminary matter, the Federal Meals, Drug, and Beauty Act (FDC Act) precludes the importation of unapproved prescription drug merchandise, together with variations of FDA-approved medication meant for distribution in overseas markets just like the EU. As documented in a Congressional Analysis Service Report, FDA has taken the place that even a foreign-made drug that has the identical lively ingredient and is made by the identical producer of an FDA-approved drug is “extremely unlikely” to “meet all the necessities within the [FDC Act] for approval” such that it could be eligible for importation into the U.S. As an alternative, FDA’s webpage on Private Importation supplies that “[i]f a drug is accredited to be used out of the country however is an unapproved new drug within the U.S. it’s unlawful to import.”
Congress afforded FDA discretion to waive the prohibition on importation of unapproved prescribed drugs the place importation is for private use and the drug doesn’t seem to current an unreasonable threat to the person. FDC Act § 804(j)(1), (2). FDA might subject such waivers by regulation or on a case-by-case foundation. Congress additionally directed FDA to subject steering describing circumstances underneath which FDA constantly would grant such waivers. This provision is efficient solely upon certification to Congress underneath FDC Act § 804(l) that the implementation of a waiver system would “pose no further threat to the general public’s well being and security” and would “lead to a major discount in the price of lined merchandise to the American client.” Absent such a certification, the provisions of FDC Act § 804 legally usually are not in impact.
Notice – That is what the Could 12 Government Order is requiring – that HHS contemplate certifying to Congress that non-public imports will pose no further threat to the general public’s well being and security.
The Could 12 EO relating to private importation is comparable on this regard to the EO from 2020. President Trump, at the moment, directed HHS and FDA to facilitate “grants to people of waivers of the prohibition of importation of prescribed drugs,” topic to the caveat that “such importation poses no further threat to public security and ends in decrease prices to American sufferers, pursuant to part 804(j)(2) of the Federal Meals, Drug, and Beauty Act (FDCA), 21 U.S.C. 384(j)(2).” Slightly than obviate the necessity for a certification to that impact, the EO mandates that such waivers are granted solely as “in keeping with relevant legislation,” which, once more, requires a certification underneath 804(l) for 804(j) to be in impact. Whereas then-Secretary of Well being and Human Companies, Alex Azar, made a certification to Congress about different provisions in §804 of the FDC Act (particularly, 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). Particularly, the certification letter states that “[t]he private importation provisions of part 804(j) of the FD&C Act usually are not being applied . . . and thus part 804(j) shouldn’t be at the moment in impact.” Secretary Azar goes on to say “[a]ny implementation of part 804(j) . . . would happen by a separate certification.” No such separate certification has been issued up to now.
Because of the dangers concerned in private importation, FDA particularly refused to implement a proper private importation coverage. See Proposed Rule, Importation of Prescription Medication, 84 Fed. Reg. 70,796, 70,800 (Dec. 23, 2019). In a Proposed Rule implementing provisions regarding the importation of sure prescribed drugs from Canada, FDA defined that it “shouldn’t be proposing to implement the non-public importation provisions in part 804(j)” as a result of imported drugs “pose important challenges for FDA and its capacity to adequately safeguard the standard and security of medication taken by U.S. shoppers.” FDA acknowledged that “there are pharmacy web sites that function legally and provide comfort, privateness, and safeguards for buying medicines,” however there are various that fail to stick to safeguards adopted by pharmacies licensed within the U.S. Accordingly, FDA did “not implement private importation provisions underneath part 804(j) of the FD&C Act” when it adopted guidelines implementing different provisions in part 804 of the FDC Act. And whereas the Last Rule acknowledges that EO 13938 directs FDA and HHS to facilitate waivers underneath part 804(j) of the FDC Act, FDA maintained that it was “not implementing the non-public importation provisions in part 804(j) of the FD&C Act by this rulemaking.” Last Rule, Importation of Prescription Medication, 85 Fed. Reg. 62,094, 62,097 (Oct. 1, 2020).
So far, neither FDA nor HHS has issued a steering doc describing circumstances by which the companies will constantly grant waivers, as required underneath FDC Act § 804(j)(2). FDA has, nonetheless, set forth on its web site a coverage for “private importation.” Beneath that coverage, FDA would allow imports of Over-the-Counter remedy and restricted imports of prescription drug merchandise for private use. https://www.fda.gov/business/import-basics/personal-importation. With respect to prescription drug merchandise, FDA will enable private imports if the product is for a severe situation for which efficient remedy might not be obtainable domestically; there isn’t a recognized commercialization or promotion of the product to individuals within the U.S.; the product doesn’t characterize an unreasonable threat; the buyer affirms in writing that the product is for private use; and the amount shouldn’t be greater than a three-month provide.
It’s onerous to learn the tea leaves on the way forward for private imports. FDA has beforehand issued Warning Letters to entities facilitating the importation of overseas medication and maintains an lively import alert relating to these merchandise, final up to date on April 14, 2025. That import alert notes the next:
FDA has noticed overseas unapproved prescribed drugs provided on the market in america by unsafe on-line pharmacies which poses a major public well being concern. Unapproved prescribed drugs current severe security and effectiveness issues. Furthermore, FDA-approved variations of those medication are sometimes obtainable in america. Subsequently, this import alert is meant to establish recognized distributors, together with on-line pharmacies, of unapproved prescribed drugs to U.S. shoppers.
There are inherent dangers to shoppers who buy unapproved new medication and misbranded medication. Unapproved new medication don’t carry the identical assurances of security and effectiveness as these medication topic to FDA oversight. Medication which have circumvented regulatory safeguards could also be contaminated, comprise various quantities of lively components, or comprise completely different components altogether. In analyzing imported medication despatched by the mail, FDA has recognized unapproved medication, counterfeit medication, improperly labeled medication, medication that failed to satisfy particular storage situations, and medicines that require supervision of a practitioner licensed by legislation to manage them.
It’s not clear whether or not the Could 12 EO will result in a certification to Congress that non-public imports pose no further threat to the general public’s well being and security. That place is at odds with FDA’s historic stance. Given the unprecedented turnover inside FDA and new management, nonetheless, FDA’s historic stance might not be related.
