Tirzepatide Lawsuit Against the FDA: Why, and What’s Next?

What Was the Lawsuit About?

On December 15, 2022, the FDA added tirzepatide to its drug shortage list, which allowed compounding pharmacies to legally produce it due to the shortage. Then, on October 2, 2024, the FDA removed tirzepatide from the shortage list, stating that the supply had stabilized. As a result, compounding pharmacies could no longer legally produce tirzepatide because they’re only allowed to compound drugs listed as in shortage.

Are the compounding pharmacies will stop production and distribution?

Since compounded tirzepatide is no longer authorized under FDA rules, compounding pharmacies now have strict deadlines to cease production and distribution. Some compounding pharmacies (503A Pharmacies: medications tailored to individual prescriptions) has started to stop and distribute compounded tirzepatide on February 18, 2005, but some may have already passed this deadline, as the FDA allowed them to continue temporarily. Also, other compounding pharmacies (503B: outsourcing pharmacies, larger-scale) still continue to produce and distribute compounded tirzepatide, but must halt their production and distribution by March 19, 2025.

What is the current update about this situation?

The Outsourcing Facilities Association (OFA) filed a lawsuit against the FDA, challenging the removal of tirzepatide from the shortage list. They argued that there’s still a significant shortage and that patients would suffer without access to compounded versions of the drug. They sought a preliminary injunction to temporarily block the FDA’s decision, allowing compounding pharmacies to continue producing tirzepatide while the case was being decided.

However, on March 6, 2025, a federal judge denies the preliminary injunction, meaning the FDA's decision stands, and compounded tirzepatide remains unauthorized.

Is there an ongoing attempt to reverse this decision?

Even if the OFA continues the lawsuit, there’s no guarantee that compounding can continue during the legal process. The court has already rejected the injunction, so there’s no automatic legal protection for compounding during the case.

If the OFA wins in court, compounding could be allowed again, but it could take months or even years. If you rely on compounded tirzepatide, you should start making backup plans. You have to take note that compounded tirzepatide (or semaglutide- which will also follow the fate, possibly) is not the only option for medical weight loss. Consult your healthcare provider to discuss your options.

What Are the OFA’s Legal Options Moving Forward?

There are options that can be considered by the OFA to continue the battle to have an access on compounded tirzepatide.

They can appeal the injunction ruling, but this is unlikely to succeed, just because appeals for preliminary injunctions rarely succeed unless there’s a clear legal error. However, the likelihood of success for this option is low, but everything is still possible in the real world.

Another option is to continue the main lawsuit against the FDA, however this is very challenging. While the injunction is denied, the main lawsuit is still ongoing. The likelihood of success for this option is moderate, but it's an uphill battle.

Suing FDA under the Administrative Procedure Act (APA) for Arbitrary and Capricious Decision-Making is the strongest option for this battle. For this lawsuit, it will claim that the FDA's decision to remove tirzepatide from the shortage list was arbitratry and capricious. "Arbitrary and Capricious" means a decision or action that is made without a reasonable basis, often ignoring key facts or relevant information, essentially based on whim or personal preference rather than sound judgment or established rules. It implies a willful and unreasonable action without proper consideration of the circumstances or facts involved. The likelihood of success for this option is moderate to high, if strong evidence is provided.

Of course, it is important to note that these three options are expensive (millons of dollars!) and compounding pharmacies would more likely not spend their earned profits to proceed with the battle. Another option is through lobbying in the congress for legislative relief. The success of this option depends on public and political support. There is actually an ongoing effor for this and you can sign a petition here!)

What are the options for patients?

If you only rely on compounded tirzepatide (or semaglutide) for weight loss, of course with healthy diet and exercise, you may need to switch to the brand-name version (who holds the patent of this medication) such as Mounjaro and Zepbound. However, these medications are expensive amounting close to ~$1,000 a month. If your budget does not allow you access in this medication, Zepbound is now offered in vials through Lilly Direct for cash-pay/self-pay option for a lower cost (But still expensive).

There are other options aside from tirzepatide (or semaglutide) for medical weight loss. Talk to your healthcare provider and discuss weight loss option. However, not all primary care providers are comfortable with medical weight loss, but they can surely refer you to a specialist that offers this service.

What's Next?

The lawsuit is still ongoing, and the OFA may appeal, challenge the FDA’s decision under the APA, or seek legislative action. However, compounding will NOT be protected during this process, and the March 19, 2025 deadline for 503B pharmacies is firm unless a court ruling changes things. Patients should stay updated and discuss alternative options with their doctors, including patient assistance programs for brand-name tirzepatide or other medications.

What is the stand of RealCare Wellness with this ongoing matter?

RealCare Wellness was founded with a mission to make healthcare accessible to people. Everyone deserves the right to access services and medications which they can afford, and the cost of medications should not stand in the way of people's well-being. RealCare Wellness firmly believes that affordable services and medications should be a right, not a privilege, and should not be dictated by anyone who is in authority (big pharmas, health insurance companies, and even the government!).

The removal of compounded tirzepatide from the shortage list, despite ongoing access issues, threatens that fundamental right. It is essential for the FDA and lawmakers to consider the real impact this decision has on patients who rely on these medications to manage their health. We all deserve the opportunity to live healthy lives without being financially burdened by the high cost of medications. Access to affordable care is something that should be guaranteed for every individual, regardless of their financial situation.

For the time being, we are business as as usual as our partnered compounding pharmacies assured continued production and supply. Our service to provide access to our new and existing patients is in conjunction to the availability of our partnered compounding pharmacies. We will also assist our patients to have access with Zepbound. We will continue to offer compounded semaglutide in one of our prescriptions for medical weight loss, until a definite update on the fate of compounded semaglutide will be decided upon in the near future. We will continue to offer other medications for prescriptions to patients who qualify.

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Disclaimer

The information provided in this article is not intended to be legal advice and should not be construed as such. It is solely a personal point of view based on publicly available information and individual perspective. For legal advice or guidance, please consult with a qualified attorney or legal professional.