‘Intended Use’ at Root of FDA 1st Amendment Issues: Attorney
Attorney Jeffrey Shapiro (Hyman, Phelps & McNamara) says that the FDA “intended use” regulation is a root cause of the agency’s 1st Amendment problems. Writing in his firm’s FDA Law Blog, Shapiro says the issues created by an FDA 1/9 final rule that created a new “totality of the evidence” standard for determining the intended use of a product continue to “fester.”
“It appears that FDA has now written itself a blank check to find whatever intent it wishes to find,” Shapiro writes, “using an unconstrained calculus as to what the ‘totality of the evidence’ shows. Worse, the manufacturer’s knowledge can be part of this evidentiary mix, thus negating the long overdue proposal to eliminate ‘knowledge’ as an element of intended use.”
He reviews the petition to stay and for reconsideration filed with FDA by three drug industry groups 2/8, and says it argues that the totality of the evidence standard is so vague that it may even raise due process concerns as well as being in violation of the Administrative Procedures Act (APA).
According to Shapiro, it’s a safe bet that FDA will not grant the petition. “If FDA persists,” he says, “it may find itself in court defending the new final rule. The outcome of litigation is never a sure thing, but this rule is definitely vulnerable, on APA grounds if nothing else. One wildcard is the new Trump administration. It is not clear how management will view the new rule or what they might do to stop it, especially if it goes into effect while the Obama holdovers continue to run FDA. (The final rule was supposed to become effective on 2/8, but it was caught up in the regulatory freeze imposed by the Trump administration. The new implementation date is 3/21.)”