The news of Martin Makary’s nomination as President-elect Trump’s pick for FDA commissioner could be a pivotal moment for the compounded GLP-1 community. Makary currently serves as an executive at Sesame—a telehealth company that connects patients with prescribers of compounded medications—bringing a unique perspective to an FDA embroiled in one of its most contentious debates. At stake? The future of compounded tirzepatide and semaglutide, lifelines for millions of patients navigating shortages and unattainable costs of branded medications.
Why Makary’s Nomination Matters to Patients
For patients who have relied on compounded GLP-1 medications, the FDA’s recent actions—like removing tirzepatide while considering removing semaglutide from the drug shortage list—have felt like a direct attack on critical access. Compounded medications have been a vital solution for those priced out of branded drugs like Mounjaro and Wegovy, offering a more affordable path to obesity and diabetes management.
Makary’s connection to Sesame, a platform that facilitates the prescription of compounded medications, signals that he may uniquely understand the essential role compounding plays for patients. This could potentially signals that the FDA, under his leadership, would adopt a more patient-focused approach to compounding regulations.
The Battle Over Compounded GLP-1s
The tension between compounding pharmacies and pharmaceutical giants like Eli Lilly and Novo Nordisk has been heating up for years. The removal of tirzepatide from the FDA’s shortage list earlier this year has complicated much of the compounding for these drugs, even as patients in certain regions still reported difficulty accessing branded versions.
For Big Pharma, the end of compounding means protecting their market share and exclusivity. For patients, it’s a devastating blow, cutting off affordable access to copies of branded medications that are legally permitted during official drug shortages. Makary’s leadership has the potential to shift this balance—but in which direction?
What Could Change Under Makary’s Leadership
Makary’s background with Sesame gives hope to advocates for compounded GLP-1 medications. If confirmed, he would take over an FDA that has largely sided with pharmaceutical companies on compounding issues, even when patients were left without alternatives. Here’s what we might expect:
Reinstating Shortage Listings: Makary could push to reconsider how the FDA determines drug shortages. By reinstating tirzepatide on the shortage list (a decision that is currently in litigation), he could open the door for compounding pharmacies to continue production, giving patients a more stable option while patent holding manufacturers struggle to provide adequate supply.
Patient-Centric Regulations: Makary’s telehealth background might inspire a more patient-focused FDA, one that prioritizes accessibility and affordability over corporate interests. Clearer guidelines on when compounding is permissible could empower pharmacies to act in patients’ best interests without fear of regulatory retaliation.
Conflict of Interest Concerns: Critics may argue that Makary’s ties to a company with connections to compounding create a conflict of interest. While this scrutiny is likely, it also highlights the pressing need for an FDA that puts patients first—a stance that Makary may champion given his unique experience.
Continued Corporate Pressure: On the flip side, Big Pharma’s influence over the FDA won’t disappear overnight. If Makary leans into that pressure, compounded GLP-1s could face even tighter restrictions, further limiting patient access.
Ad:
A Fight for Patients’ Rights
At On The Pen, we champion compounded GLP-1 copycat medications as a critical solution during shortages. Patients should never have to alter their therapy because they cannot access branded versions of their medications. Compounded tirzepatide and semaglutide represent more than just affordability—they represent hope for those left behind by the lack of abundance in the branded pharmaceutical market.
If Makary truly prioritizes patients, his leadership could restore that hope. By reevaluating the FDA’s approach to shortages and compounding, he has the potential to align the agency with the needs of everyday people rather than the interests of pharmaceutical giants.
Why This Matters Now
The timing of Makary’s nomination is crucial. As the FDA faces ongoing litigation from the Outsourcing Facilities Association over compounded tirzepatide, Makary’s stance could influence the agency’s legal and regulatory strategies. Will he move to protect compounding as a vital part of the healthcare ecosystem? Or will he maintain the status quo, further restricting access for patients in need?
These decisions will shape the future of obesity and diabetes care in the United States. For patients, the stakes couldn’t be higher.
What’s Next?
Makary’s confirmation hearings will undoubtedly reveal more about his vision for the FDA and how he plans to address compounding. Until then, it’s up to all of us to advocate for policies that protect patient access to affordable treatments.
As always, On The Pen will continue to monitor these developments and keep you informed. Sharing this article is a powerful way to amplify this conversation. Let’s ensure patients’ voices are heard loud and clear as this story unfolds.
Stay tuned to OnThePen.com for more updates and in-depth analysis on the latest developments in weight loss and diabetes treatments. Sharing this article is a powerful form of advocacy that brings us closer to our goal of educating the masses and reducing the stigma of obesity. If you found this article insightful, please share it within your networks, especially in Facebook groups and Reddit forums dedicated to GLP-1 medications and diabetes management. Together, we can make a difference.