OFA Fires Back at FDA in Tirzepatide Case, Redactions Raise Questions as Decision Looms

The Outsourcing Facilities Association (OFA) has filed its latest response in the ongoing lawsuit challenging the FDA’s decision to remove tirzepatide from the drug shortage list. The document, heavily redacted due to proprietary information under seal from the FDA and Eli Lilly, raises questions about the transparency of the FDA’s decision-making process. With so much blacked out, it is difficult to gauge the full scope of the FDA’s reasoning. This lack of transparency is a central theme of OFA’s argument, as they continue to question the validity of the FDA’s claim that the shortage is over.

The sheer volume of redactions in this latest filing highlights just how much of the FDA’s case hinges on data provided by Eli Lilly, the manufacturer of FDA-approved tirzepatide products like Mounjaro and Zepbound. OFA argues that the FDA has relied entirely on Lilly’s confidential information to justify delisting tirzepatide from the shortage list, without giving the public any opportunity to verify the claims. OFA points out that if the shortage truly is over, then the numbers should speak for themselves. The absence of transparent data suggests that the FDA’s decision may be based more on Lilly’s business interests than on actual supply and demand dynamics.

At the heart of this legal battle is the preliminary injunction that OFA is seeking. If granted, the injunction would allow compounding pharmacies to continue producing tirzepatide while the lawsuit plays out. If denied, compounded tirzepatide could be pulled from the market for 503a pharmacies, and shortly thereafter for 503b pharmacies. Everything now hinges on how Judge Mark Pittman rules on this issue.

From the beginning, On The Pen has closely followed this case, providing detailed coverage of every twist and turn. We had an observer in the courtroom for the one in-person hearing, where Judge Pittman was notably short with OFA’s counsel. He expressed his desire to get this case resolved as quickly as possible, which suggests that he may issue a ruling on the preliminary injunction without scheduling oral arguments. If that happens, a decision could come at any time.

The OFA’s latest filing argues that the FDA acted arbitrarily and capriciously when it removed tirzepatide from the shortage list. They claim that the agency failed to engage in proper notice-and-comment rulemaking, which would have allowed for public input and scrutiny. Instead, the FDA relied on confidential data from Eli Lilly, shielding the information from public view through extensive redactions. OFA contends that without public access to the underlying data, the FDA’s decision lacks transparency and cannot be independently verified.

OFA’s latest filing is a powerful reminder of what is at stake in this case. It is not just about legal definitions of shortages or regulatory technicalities. It is about real people who depend on this medication to manage their health. By emphasizing the human impact and questioning the transparency of the FDA’s decision-making process, OFA is making a fairly compelling case for why the court should intervene.

This case is about more than just tirzepatide. It could set a precedent for how the FDA handles drug shortages and enforces compounding regulations in the future. The outcome could reshape the balance of power between the FDA, pharmaceutical companies, and compounding pharmacies, impacting patient access to medications across the board.

The next few days are critical. On The Pen will continue to provide detailed coverage of this case and its implications for the GLP-1 medication landscape. As we await Judge Pittman’s ruling, one thing is clear: this fight is far from over.