The Trump administration is formalizing a proposal that would allow limited importation of drugs from Canada. The draft rule released on Wednesday would establish two drug importation pathways overseen by the Food and Drug Administration.
Intraocular injections would be excluded, and, due to significant concerns about whether they can be safely imported, ophthalmic treatments — which were nearly omitted altogether — will be reviewed on a case-by-case basis.
The Academy has and continues to work to ensure access to ophthalmic treatments and the affordability of drugs our patients need. We are generally support of this importation concept if done safely.
The administration’s first proposal states that wholesalers or pharmacists would be empowered to establish programs for importing drugs from Canada. Such plans would need to detail precisely which pharmacies or wholesalers would supply Canadian, FDA-approved drugs to the U.S. Notably, these programs would also have to demonstrate significant cost reductions to the American consumer.
Because Academy members have raised concern about spiking costs for generic drugs used to treat ophthalmology patients, we will evaluate how this proposal could provide relief.
The second proposal would establish procedures drug manufacturers can follow to facilitate importation of prescription drugs, including biological products that are FDA-approved, manufactured abroad, authorized for sale in any foreign country and originally intended for sale in that foreign country. This would open the door for them to import lower-priced versions of the FDA-approved drugs that are already sold in foreign countries.
Furthermore, an accompanying FDA guidance document for manufacturers specifically says that “the procedures outlined in this guidance are not intended to supplant existing procedures for temporary importation used to mitigate or prevent drug shortages.”
The mention of ophthalmic treatments in the proposal highlights the Academy’s chief concern in this issue: safety. The administration says it considered exempting all ophthalmic treatments from the program (other potential exemptions included sterile drugs, narrow therapeutic index drugs and drugs requiring special storage conditions) due to “potentially heightened safety concerns.”
Although the proposal wound up including drugs from these categories — each to be reviewed on a case-by-case basis by the FDA — it does nix importation of intraocular injections, because they pose potentially significant risk, since the “routes of administration bypass some of the body’s natural defenses.”
If the draft rule is adopted, it may still be years before states and other entities can actually implement importation plans. States would need to draft their importation proposals to comply with the new federal rule. Imported drugs will also need to bear new FDA-approved labels and undergo safety testing. The requirements could prove prohibitive for potential importers.
Drug manufacturers have so far been slow to embrace the administration’s proposals. The Canadian government has also expressed opposition due to potential ramifications for its own prices and supplies.