The Biden administration has filed a motion in federal court seeking to dismiss a lawsuit brought by a pharmaceutical lobby group against the Department of Health and Human Services (HHS) that aims to block prescription drug imports from Canada.
With the motion to dismiss, the Biden administration is essentially siding with Florida and New Mexico, the only states that have applied for approval of Canadian drug imports.
Florida Gov. Ron DeSantis said at a press conference in Lakeland, Florida, on May 28 that importing prescription medicines from Canada would save Floridians $80 million to $150 million in drug costs within a year, according to ClickOrlando. Florida’s application for HHS approval to import Canadian drugs has been under review for approximately six months.
“We were told that if it wasn’t denied last week that we should assume it’s going to be approved, but you know we want to get that final approval, because once we do, then all this stuff goes in motion,” DeSantis said.
The Biden administration’s motion, filed on May 28 in the U.S. District Court for the District of Columbia and obtained by The Epoch Times, calls for the suit to be dismissed on grounds of standing and “ripeness,” which is the idea that the lawsuit was brought too early—before the plaintiffs incurred any actual injury.
“Because Plaintiffs cannot establish standing or ripeness, the Court cannot decide the case,” wrote attorneys James Harlow and Kimberly Stephens, arguing that since “the case demonstrates neither fitness nor hardship, it is not ripe. The prudent and legally required course is to defer review.”
The motion relates to a lawsuit filed by Pharmaceutical Research & Manufacturers of America (PhRMA), a trade group representing companies in the U.S. pharmaceutical industry. In November 2020, the group filed a complaint challenging a final rule issued by HHS and the Food and Drug Administration (FDA) that PhRMA claims allows “pharmacists and wholesalers to import certain prescription drugs from Canada into the United States without drug manufacturers’ authorization or oversight, presenting significant safety risks.”
In issuing the rule, which went into effect in November of last year, the FDA said its aim was “to achieve a significant reduction in the cost of covered products to the American consumer while posing no additional risk to the public’s health and safety.”
The rule was to be implemented by time-limited Section 804 Importation Programs (SIP), with applicants having to specify the eligible drugs, which the FDA described as “those that could be sold legally on either the Canadian market or the American market with appropriate labeling.”
It also required U.S. importers to conduct or arrange for testing of the eligible prescription drugs for authenticity and degradation, and to make sure they comply with existing specifications and standards.
PhRMA argued in its complaint (pdf) that there were “risks inherent in importation outside the drug manufacturer’s control” and that it was likely “such importation would yield little to no savings for American consumers.”
The group also argued that the rule violated manufacturers’ First Amendment rights and “raise serious questions under the Fifth Amendment Takings Clause,” which is the idea that private property may not be taken for public use without fair compensation.
In its filing, attorneys representing the Biden administration provided a series of arguments in support of the safety measures inherent in SIP applications. They also argued that, since the rule has never been implemented, the plaintiffs have failed to show that their injury is “actual or imminent, not conjectural or hypothetical.”
After the lawsuit was filed, PhRMA Executive Vice President and general counsel James Stansel argued that FDA resources were stretched thin in responding to the pandemic and that the administration was exposing Americans to risks.
“It is alarming that the administration chose to pursue a policy that threatens public health at the same time that we are fighting a global pandemic,” Stansel said in a statement.
“FDA has noted it is struggling to keep up with approving medicines while working around the clock to support COVID-19 therapeutics and vaccine development. Despite this, the administration is willing to divert precious FDA resources away from these efforts and to expose Americans to the risks that come with drug importation schemes.”
Former President Donald Trump backed the Canadian drug import plan as a way to get cheaper medicines.
DeSantis was the first state governor to submit a proposal under the plan.