BOSTON (SHNS) – Health policy analysts say a new court filing signals the Biden administration’s commitment to defend a rule published under the Trump administration to enable state importation of prescription drugs from Canada.
The U.S. Department of Health and Human Services filed a motion Friday urging a U.S. District Court to dismiss a challenge by the Pharmaceutical Research & Manufacturers of America to the federal rule. Justice Department trial attorneys James Harlow and Kimberly Stephens said the plaintiffs were attempting to preemptively launch a “wholesale attack” on the rule.
Six states, including Maine, New Hampshire and Vermont, have enacted laws enabling them to design a Canadian importation program and to pursue federal authorization, according to the National Academy for State Health Policy.
Sixteen other states are considering drug importation bills, including Massachusetts, where Rep. Lenny Mirra of Georgetown has filed legislation (H 2377) that is pending before the Joint Committee on Public Health. The same committee last session buried Mirra’s drug importation bill in a dead-end study order. Noting that several states are designing programs within the confines of the federal rules, the academy on Tuesday said “the action by the Biden administration to defend the rule, if successful, opens the door to negotiations with states about how best to proceed.”
In their court filing, Harlow and Stephens wrote that Congress in 2000 and again in 2003 enacted a “statutory pathway” under which certain prescription drugs could be imported from Canada. The effectiveness of the statutes, they argued, hinges on certification by the U.S. Secretary of Health and Human Services that programs would “pose no additional risk to the public’s health and safety” and “result in a significant cost reduction to American consumers for covered drugs.”
The certification needed to bring the statute into effect was issued by the secretary in September 2020 under the Trump administration. Simultaneously, the U.S. Department of Health and Human Services and the Food and Drug Administration promulgated a rule that established a regulatory framework for states to propose Section 804 Importation Programs that would allow them to import eligible prescription drugs from Canada. The Justice Department attorneys say the drug industry trade group challenged the certification and the rule on behalf of their members “but neither action has harmed any of Plaintiffs’ members” and “no future harm could possibly arise unless and until FDA and other third parties, including State governments, take certain steps — eventualities that remain speculative.”
The attorneys said the plaintiffs’ challenge “will not ripen” at least until a state important program is authorized by the FDA. Florida and New Mexico appear the furthest along in the process — both submitted importation program applications following publication of the final rule.