Trade group sues FDA over ending Mounjaro/Zepbound shortage

A trade organization representing compounding pharmacies that make unbranded versions of the weight loss drugs Mounjaro and Zepbound has filed a lawsuit against the Food and Drug Administration (FDA) for declaring an end to the shortage, effectively halting the sale of “copycat” versions of these drugs.

On Oct. 2, the FDA announced that the nearly two-year-long shortage of tirzepatide, the active ingredient in Mounjaro and Zepbound, had ended. This was after the agency said it had confirmed the manufacturer, Eli Lily, had a manufacturing capacity that “can meet the present and projected national demand.”

With the shortage over, the ability of compounding pharmacies to sell unbranded, replicated versions of these drugs came to a near halt. There are two types of compounding pharmacies: 503A and 503B. The Outsourcing Facilities Association (OFA) represents 503B compounding pharmacies, which can create prescription-specific compounded drugs as well as bulk orders.

The OFA and the compounding pharmacy North American Custom Laboratories filed their lawsuit against the FDA on Monday, alleging the agency was “abruptly depriving patients of much needed treatment and artificially raising drug prices.”

“Ignoring evidence that the shortage persists, FDA removed Tirzepatide from the shortage list without notice, without soliciting input from affected parties and the public, and without meaningful rationale,” said their complaint.

The evidence that the plaintiffs cited for the shortage persisting was that the FDA noted in its announcement that “patients and prescribers may still see intermittent localized supply disruptions as the products move through the supply chain from the manufacturer and distributors to local pharmacies.”

Eli Lilly made a similar statement after the shortage was declared over, saying, “Patients’ experiences looking for a particular dose of medicine in their local pharmacies may vary. The supply chain is complex, especially for refrigerated medicines, and there may be many reasons why a particular pharmacy does not have a particular dose of the medicine in stock. ”

The FDA said it does not comment on ongoing litigation.

The OFA is asking that the FDA’s declaration of tirzepatide no longer being in shortage be declared in violation of the Administrative Procedure Act, and wants to permanently block the agency from going after 503B pharmacies for compounding tirzepatide.

The compounded drugs are sold at vastly lower prices than the branded versions. But obesity specialists have expressed concerns over these products that aren’t FDA-approved and are sometimes accessed through dubious online medical evaluations.

Some in the compounding pharmacy industry had argued the FDA should provide a transition period for those who were taking compounded tirzepatide to transition to a branded version or an alternative medication.

The FDA does provide guidance on transitioning patients to different medications when shortages are declared over.

In 2018 FDA guidance, the agency states that 503B pharmacies may fulfill orders that were received when the shortage was still in effect and may dispense or distribute medication within 60 days of when the drug was last on the FDA’s shortage list.