In late September, the FDA announced that Tirzepatide is no longer in shortage. However, last week, the Outsourcing Facilities Association, an industry compounding group, initiated a lawsuit to challenge the FDA’s decision. As a result, the FDA has paused any enforcement or regulatory action and will reevaluate whether the drug is actually in shortage based on the filing of the suit.
Brendan Pierson of Reuters reported the latest developments in this case (here) and while this may be a “short” (no pun intended) term pause, the FDA has taken the shortage claim seriously and wants to get it right. We don’t expect that the reevaluation will take long but the result could cause the Agency headaches down the road whenever the FDA declares a drug shortage resolved. Perhaps in this case though, the high cost of the drug and the high profile of the specific product makes this case different than other drug shortages.
Could this back-and-forth signal the FDA’s concern regarding the reversal of the Chevron decision and its likelihood of success in defending its initial position in court, or is this the FDA wanting to make sure that patients receiving compounded versions of the drug will not be adversely impacted? We will likely see in the coming days as the process plays out.
