As the legal showdown between the FDA and the Outsourcing Facilities Association (OFA) continues, patients who rely on compounded tirzepatide are left in a state of uncertainty. The FDA’s aggressive efforts to limit compounding of the drug—following shortages—are at the heart of this dispute, raising concerns about patient access and affordability. If you’re new to the story, I’ve covered this case extensively in previous articles and videos.
The spotlight now turns to U.S. District Judge Mark T. Pittman, a Trump appointee with a well-established record of scrutinizing regulatory overreach and holding powerful interests accountable. In previous rulings, Pittman has demonstrated a firm hand against Big Pharma, most notably when he ruled against pharmaceutical companies seeking to dismiss lawsuits related to drug pricing. His no-nonsense approach underscores his judicial philosophy: large corporations, particularly in the pharmaceutical industry, should be held accountable when their actions compromise consumer access or inflate prices to unreasonable levels.
The recent Chevron ruling has removed the court's requirement to give deference to the FDA's decision to place a drug in shortage, which is important information in the FDA vs. OFA case overseen by Judge Pittman. Judge Pittman is presiding over the case challenging the FDA's decision, with a ruling on the motion for a temporary restraining order (TRO) expected shortly after the October 15th hearing. If the TRO is granted, it would temporarily stop the FDA's enforcement actions against pharmacies compounding tirzepatide, ensuring continued access to the medication for patients, particularly those who prefer it over the branded versions, Mounjaro and Zepbound. We are currently awaiting the FDA's response to OFA's motion for the TRO, expected later today. Follow all of our On The Pen socials for up to date info.
However, it’s important to note that this ruling would only impact the FDA’s ability to enforce its restrictions—not Eli Lilly’s legal strategy. Just yesterday, Lilly sent out hundreds of cease-and-desist letters to compounding pharmacies, telehealth platforms, and medical spas, demanding that they cease the production and sale of compounded tirzepatide. This TRO would have little bearing on how these businesses respond to Lilly’s pressure, as the company can still pursue its own legal actions under different state and federal laws. It’s crucial for businesses and patients to understand that while the FDA’s enforcement might be temporarily suspended, Lilly can continue its aggressive campaign to stop compounding.
As for how this legal development may influence Lilly’s appetite to pursue legal action, that remains to be seen. On the one hand, a favorable ruling for the OFA could embolden compounders, making them more willing to continue operations despite Lilly’s pressure. On the other hand, the restraining order may incentivize Lilly to double down on its efforts, particularly if they feel the FDA’s hands are tied. This could result in increased legal pressure from the company on any business engaged in compounding tirzepatide, as we’ve already seen through their recent flurry of cease-and-desist letters.
Given Pittman’s track record of ruling against pharmaceutical companies that prioritize profits over patient access, there’s a possibility he could scrutinize whether the FDA’s enforcement actions primarily serve Eli Lilly’s interests. However, the outcome remains uncertain, and while Pittman’s past rulings suggest he may lean toward protecting patient access, each case comes with its own complexities.
If you want more insight into the intricacies of this legal battle, my previous posts offer a deeper dive into the situation.
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