The Current State of Tirzepatide, What We Learned

On October 2, 2024, roughly two weeks ago, the FDA posted on their website that Tirzepatize was no longer in shortage.  This, as you can imagine, created widespread panic and uncertainty with all those involved in medical weight loss including the most important, the patients.  Then on October 7, 2024, the Outsourcing Facilities Association of North America on behalf of its members along with Custom Laboratories (collectively, the Plaintiffs) sued the Food and Drug Administration (Defendant) seeking Injunctive Relief in Federal Court in the Northern District of Texas.  The Plaintiffs were asking for the Federal Court to enjoin the FDA from enforcement action as it relates to 503B Outsourcing Facilities.  In plain language, the Plaintiffs wanted the FDA to stop any action against outsourcing facilities from producing an essential copy of Tirzepatide under the Food and Drug Cosmetic Act.

Who are the Plaintiffs?

Custom Laboratories

Custom Laboratories D/B/A Farmakeio Custom Compounding located in a strip mall in Richardson Texas appears to be an embattled 503B Outsourcing facility with some pretty egregious violations of the Food and Drug Cosmetic Act which can be seen here in a warning letter sent by the FDA after an inspection.

This warning letter effectively put the public on notice that patients and clients should not use any sterile products produced by Custom Laboratories citing many violations and lack of safety protocols. This kind of warning letter most likely had a severe impact on their business. So being a Plaintiff in a lawsuit against the FDA was really risk free.

The Outsourcing Facilities Association of North America

Outsourcing Facilities Association of North America is an association that according to their LinkedIn page: “is the trade association representing FDA registered 503B facilities who focus on providing patients and healthcare providers with safe and effective compounded medications. OFA members work with patients, healthcare providers, and facilities on a daily basis to ensure the specific needs, of both providers and patients, for compounded medications are satisfied. OFA will continue to work with industry, governmental agencies, and healthcare providers to educate and advocate for outsourcing facilities and the critical need to ensure that patients and providers have access to the medications they need. “  Notice who they represent, 503B facilities.  Their members are NOT 503A compound pharmacies.

Background

As mentioned above, prior to this case being filed on Oct 2, 2024, the FDA announced that Tirzepatide was no longer in shortage.  This came as a huge surprise to telemedicine platforms, clinics, physicians and most importantly the hundreds of thousands of patients who could be impacted.  This created chaos and confusion for those who offered a compounded version of Tirzepatide.  The FDA regulation related to 503A compound pharmacies is clear.  Once the FDA takes a drug off the list the 503A compound pharmacies must IMMEDIATELY stop producing.  However, 503B outsourcing facilities have 60 days to produce and distribute their product.  If your company was using a 503A pharmacy your business effectively was halted; immediately and still in jeopardy.

When this happened the chaos ensued.  Companies that had significant time and resources invested were effectively put out of the Tirzepatide business.  However, if you were getting your product from a 503B you still had some time.  Even with a 503B, most marketers were getting their Tirzepatide from 503B light companies.  Meaning that they were most likely getting the 503B product from a pharmacy that was really a 503A that just obtained a 503B license.  Meaning that the standards are not as high as what an FDA registered drug manufacturer adheres to.  Although, those organizations may have a different opinion. Additionally, the product they were selling most likely had a limited Best Use Date (BUD).

Even with the guidance, there were so many questions. Can the product still be inventoried at a pharmacy? Can a marketer sell the product past the 60 days so long as the BUD date allowed?  Can a pharmacy still ship a 503B product?  What happens after the 60 days to the patients?  Will there be a break in their continuity of care? 

Unprecedented Result

In a surprising turn of events, the federal judge Mark T. Pitman granted the FDA’s request for a voluntary motion to remand and stay in the ongoing case challenging the agency’s decision to remove Tirzepatide from the drug shortage list. This decision temporarily halts any enforcement action and provides a path for the FDA to reconsider its ruling on the status of Tirzepatide, which has had a major impact on everyone involved in medical weight loss.  What is very interesting about this, is that the defendant, the FDA, submitted the unopposed motion to effectively stop themselves from taking any action against the members of OFA. Generally, when a defendant agrees to what the Plaintiff wants the Defendant knows they are in the wrong or have some serious work to defend their position.

THE ORDER:

ELECTRONIC ORDER granting Defendants; Unopposed Motion for Voluntary Remand and Stay. The Court has considered the motion in light of the governing standard. The Court has also taken into account Defendants; representation that they will not take action against Plaintiffs and their members for violations of the Federal Food, Drug, and Cosmetic Act arising from conditions that depend on Tirzepatide’s inclusion on the drug shortage list (i.e., compounding that does not meet the applicable conditions in 21 U.S.C. §§ 353a(b)(1)(D) or 353b(a)(2)(A)(ii) and (a)(5)), from the date of this order through two weeks beyond the new decision on remand and, if Plaintiffs file a motion for preliminary injunction regarding the new decision, through the Courts resolution of that motion.

It is hereby ORDERED that: 1. The case is stayed and the challenged decision is remanded to the United States Food and Drug Administration for reconsideration; 2. The parties shall file a joint status report by November 21, 2024; 3. The hearing in this case scheduled for October 15, 2024, at 11:00 a.m. is canceled. (Ordered by Judge Mark Pittman on 10/11/2024) (JRG)

What Does the Decision Mean?

The judge’s ruling allows the FDA to reevaluate its decision to remove Tirzepatide from the shortage list. This is very important because outsourcing facilities have been relying on the drug’s shortage status to legally compound Tirzepatide without facing regulatory enforcement.

Temporary Relief for OFA Members

The FDA has agreed to hold off on enforcement actions related to the compounding of Tirzepatide during the remand period. This means that OFA’s members and telehealth providers and fulfillment partners can continue filling prescriptions for compounded Tirzepatide under certain conditions until the FDA completes its review. This is a temporary but impactful win for OutSourcing Facilities relying on compounded Tirzepatide to serve patients.

Why This Matters

For patients and healthcare providers who depend on compounded Tirzepatide, the judge’s decision provides temporary relief. It ensures that 503B Outsourcing Facilities and its customers and partners will not face immediate enforcement actions from the FDA, allowing them to continue their operations for the time being.

For the FDA, this remand is an opportunity to reconsider its decision in light of the legal challenge and avoid further litigation. By diving deeper into the Tirzepatide shortage status, the agency may either uphold or change its original decision, which will have long-term implications for the availability of compounded versions of the drug.

Next Steps

The FDA has been given time to  review its decision to remove Tirzepatide and will submit a joint status report by November 21, 2024, updating the court on its progress. It is unlikely they will come to a decision by then.  During this time, OFA members(503B Outsourcing Facilities) can continue compounding Tirzepatide, but the window is limited for now, but unclear if 503A’s can still compound.

End of the day

For now, the judge’s decision provides a temporary relief for 503B compounding pharmacies and telehealth companies and fulfillment partners. Patients who rely on compounded Tirzepatide will continue to have access in the short term, but the long-term future of compounded Tirzepatide remains uncertain especially with a 503A compounding pharmacy. As the FDA reconsiders its decision, the healthcare industry will be watching closely to see how this case unfolds and what it means for the future of compounded GLP-1 medications.

What we learned

We all learned that most companies, patients, physicians and pharmacies were not ready.  We learned that all of those telehealth companies that were trying to squeeze an extra dollar out by using 503A compounding pharmacies were put in a difficult spot.  Many have stopped completely, while others are still evaluating their options including using a 503B product like the products we offer at BlueVaseRX.  At BlueVaseRX we are not the judge and the jury, but we saw many clients panic when this happened.  The good news is that with our product, they realized they had time.  As a registered drug manufacturer with a 503B, it was clear where we stood. Our clients had time to evaluate the regulatory landscape while working with us to ensure continuity of care.  They learned that trying to make a little more money was more of a short-term play and not a long-term growth strategy.  The stress and anxiety we heard from our clients was palpable.  We are here to help.  We are here to help to continue to provide access to patients, physicians, pharmacies and telehealth providers to ensure the continuity of care for your patients. 

If you are a customer or have thought about working with us, now is the time.  There are some things that aren't clear from this Order, such as, does this protect a 503A pharmacy that is compounding Tirzepatide? There are some things however that are certain in this space. We have the capability of producing more product than any 503B or 503A that exists today.  Our products are of the highest quality on the market.  We have the longest BUD date and many other unique selling points that are great for your business and your patients. 

If you already have been working with one of our sales professionals, please reach out today or fill out this information here and we will get to you ASAP.  Protect your business from uncertainty and maintain customer continuity of care with us.