Scott Brunner, CEO of Alliance Pharmacy, has highlighted ongoing challenges faced by pharmacies in acquiring FDA-approved tirzepatide drugs in sufficient quantities for patients transitioning from compounded versions to commercial products. This statement was made in a LinkedIn post.
"FDA acknowledges in its letter that “many” patients may still be inconvenienced in the short term by the unavailability of the commercial drug," said Brunner, according to LinkedIn. "It's nice of them to note that, but it's cold comfort if you're one of those patients."
According to the Houston Chronicle, large pharmaceutical companies influence drug pricing in the United States through strategies such as patent protections, market exclusivity, and complex supply chains involving pharmacy benefit managers. These practices often result in high costs for brand-name medications, limiting accessibility for many patients. Compounding pharmacies have emerged as alternatives by creating customized medications tailored to individual needs, especially during drug shortages. However, their role has been contentious due to concerns over safety and regulatory compliance.
The FDA declared the end of the tirzepatide shortage in December 2024, leading to increased availability of FDA-approved tirzepatide drugs like Mounjaro and Zepbound in U.S. pharmacies. This decision has prompted compounding pharmacies to cease production of compounded versions of these medications. As a result, patients now have reduced access to specialized medications that larger pharmaceutical companies do not produce.
In 2024, the U.S. compounding pharmacy market was valued at approximately $5.4 billion, with projections estimating growth to around $8.72 billion by 2034. According to Bio Space, this growth is driven by increasing demand for personalized medications, especially where commercial alternatives are inadequate or unavailable. Despite regulatory challenges, compounded medications continue to play a crucial role in addressing unique patient needs.
Brunner serves as the Chief Executive Officer of the Alliance for Pharmacy Compounding (APC). With over 35 years of experience in association management, he has held leadership positions in various trade associations, including the National Community Pharmacists Association and the Georgia Pharmacy Association. His expertise lies in advocacy and communications within the pharmaceutical sector.