Biden HHS seeks to dismiss PhRMA’s lawsuit to stop Canadian drug imports
As the FDA has yet to authorize any state plans to import prescription drugs from Canada, the Biden administration called on the US District Court for DC late last week to dismiss a PhRMA lawsuit over the imports because any potential harms remain speculative.
Biden’s HHS said PhRMA’s “wholesale attack” on the rule that allows states to submit such plans to the FDA has not yet affected their member companies “in any concrete way and perhaps never will.”
The call to dismiss the suit, which aligns the Biden administration with the Trump policy, notes that two proposals from Florida and New Mexico have been submitted to FDA, but the agency has not offered a timeline for when it will decide on either one.
Law firm Covington & Burling, on behalf of PhRMA, filed a citizen petition with the FDA in January to deny Florida’s application, and it filed another citizen petition in March calling to deny New Mexico’s too.
For Florida, PhRMA criticized the proposal because it does not include the name of a Canadian wholesaler that would be necessary for the plan to work, and it delegates significant responsibilities to a private sector vendor to work out the details. For New Mexico, PhRMA took issue because the state did not provide a foreign seller, importer, or FDA-registered repackager or relabeler, and it provides only the first iteration of the list of drugs to be imported.
But Biden’s HHS explains how the rule allowing the submission of these state proposals asks nothing of PhRMA’s member companies. And because the rule and state proposal process has only been in the works for a few months, FDA needs time to evaluate whether to accept or deny the applications, Biden’s HHS maintains.
“To even be eligible for authorization, a program must satisfy upfront (and continue to demonstrate thereafter) a host of stringent regulatory requirements related to patient safety and drug supply chain security, as well as show significant cost savings to American consumers,” the Biden administration’s motion to dismiss says. “FDA possesses discretion to deny any proposal that does not facially meet the regulatory requirements. Even if a proposal is facially complete, the agency still may withhold authorization.”
Following the court filing, Florida Gov. Ron DeSantis (R) on Friday asserted that it “puts the Biden Administration on the record in support of the FDA rule,” which he said could potentially save the state between $80 million and $150 million in the first year alone. He also pushed the FDA to act quickly in deciding on the proposal, saying, “Floridians have been waiting long enough for lower drug prices, and there is no good reason to keep them waiting.”
