DC court overrules PhRMA's bid to shut down drug imports from Canada
The DC Circuit Court has struck a blow against the pharmaceutical lobbying group PhRMA and other plaintiffs’ attempt to stop states from importing drugs from Canada.
Joined alongside public health group Partnership for Safe Medicines and advocacy group Council for Affordable Health Coverage, PhRMA was rebuffed by Judge Timothy Kelly on Monday, who dismissed the civil suit due to a lack of standing.
FDA issued a rule back in 2020 that would allow states to import certain prescription drugs from Canada, but has yet to sign off on any of the state plans for importation.
From Kelly’s ruling:
The Department of Health and Human Services is considering allowing prescription drugs to be imported from Canada under a statute that has lain dormant for decades. Plaintiffs, a collection of organizations with various interests in American healthcare, say that decision would be mistaken and that it was started by unlawful processes. But no organization, nor any of their members, faces a concrete risk of harm from the inchoate importation program, as is required when suing. So the Court must dismiss this case for lack of standing.
The 26-page ruling noted that in order to have standing, plaintiffs must prove that they have suffered an “injury in fact,” that the injury is traceable to the defendants’ conduct, and that the injury is likely to be remedied by a favorable decision. And in two different aspects, the plaintiffs had no standing to bring the case against the federal agencies, Kelly ruled.
One was that “[t]he cognizability of each of those injuries, as the Court will explain, depends on the likelihood that an individual member’s drug or drugs will be the subject of a pre-import request under an approved SIP (state implementation plans). Because it is impossible to do more than speculate about that likelihood, Plaintiffs have not established an injury-in-fact.”
Claims that drug importation would impede advocacy efforts, according to Kelly, are “prototypical statements of harm to ‘abstract social interests.’”
“Plaintiffs nowhere allege that their ability to provide services has been ‘perceptibly impaired’ or describe any ‘inhibition’ of their ‘daily operations,’” Kelly added.
The complaint was first filed more than two years ago in late 2020 against HHS, FDA and the then-heads of those agencies under the Trump administration, Alex Azar and Stephen Hahn.
The complaint said at the heart of the suit were HHS and FDA actions that, according to the complaint, “would permit pharmacists and wholesalers to import certain prescription drugs from Canada into the United States without drug manufacturers’ authorization or oversight, presenting significant safety risks.”
Multiple states have been working on trying to reduce the cost of prescription drugs for their residents. Florida sued the FDA last year over the agency’s alleged failure to authorize the state’s plan to import drugs from Canada. The state had turned over a proposal years earlier.
Colorado recently joined in, revealing quietly last year that the state was working on an application to FDA for a partnership with three companies to import lower-cost drugs approved from Canada to the US. The plan was estimated to save Colorado residents 60% on prescription medicines if US regulators signed off.
PhRMA’s senior director of public affairs Nicole Longo tells Endpoints News in a statement:
PhRMA’s concerns with the legality of the 2020 drug importation final rule remain unaddressed by the Judge’s decision, as well as our belief that it threatens public health. In the final rule, the administration punted the responsibility for demonstrating safety and cost savings to state governments. This is despite the clear requirement under federal law that the Secretary of HHS must certify that imported drugs both pose no additional risk to public safety and will lead to significant savings for the American consumer. The rule needlessly puts the health and safety of Americans in jeopardy.
