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# HHS Asks Court to Dismiss Drug Import Suit
- URL: https://www.fdaweb.com/hhs-asks-court-to-dismiss-drug-import-suit/
- Published: 2021-06-01T12:00:00.000Z
- Updated: 2026-09-14T17:01:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149442

HHS is asking the DC federal court to dismiss an 11/2020 suit filed by Pharmaceutical Research and Manufacturers of America, the Partnership for Safe Medicines, and the Council for Affordable Health Coverage that asked the court to block the Trump administration HHS and FDA from implementing a program to permit states to import some drugs from Canada. The HHS [response](http://www.fdaweb.com/download.php?file=7158538-1--99393.pdf) says the advocacy groups do not have legal standing to bring the suit because they cannot establish any actual injury suffered by their members that is traceable to the HHS certification of a rule permitting the drug importation program.

HHS says the suit was filed before any Section 804 Importation Program (SIP) had even been proposed, and while two proposals have been submitted, none has been authorized.

“The possible future injuries to plaintiffs’ members are overly speculative and not imminent,” the filing says, “involving an attenuated chain of possibilities with independent third parties and discretionary decisions of various government actors.”

HHS also says that regulations ordinarily are not ripe for judicial review until they are applied in a particular instance that provides a concrete factual setting and manageable scope for review, and such is the case in this instance.

“Plaintiffs’ challenge will not ripen at least until a SIP is authorized by FDA,” HHS says. “Litigation of plaintiffs’ claims within the context of a particular authorized SIP will allow the factual and legal issues to crystallize within manageable dimensions and permit FDA to bring its expertise to bear. Until then, the certification and the rule ask nothing of plaintiffs’ members, who are free to conduct their business as they see fit. This case is not justiciable and must be dismissed.”

The stakeholder [suit](https://www.fdaweb.com/3-groups-sue-to-block-drug-import-rule/) said the FDA final rule disregards key protections of the Federal Food, Drug, and Cosmetic Act that are designed to ensure patient safety. They said that former HHS secretary **Alex Azar**’s statements on safety and cost savings in his certification of the plan were made with no supporting evidence and that he punted the responsibility for safety and cost savings to state governments.