Press Release

Southlake, TX – April 2, 2024 – EVEXIAS Health Solutions, EVEXIAS Medical Centers and FarmaKeio Pharmacy have filed suit against the FDA in the United States District Court for the Northern District of Texas challenging the FDA’s peptide ban as illegal under the Administrative Procedure Act.

Recently, in September 2023, the FDA prohibited pharmacies from compounding therapies with 17 different kinds of peptides by adding these peptides to its Category 2 Bulk Substances List. The FDA did so without any meaningful explanation for its action and without any notice to or input from pharmacies, other medical practitioners, or patients. The FDA’s prohibition of these peptides has no basis in law and hamstrings doctors treating patients with conditions that are not responding to traditional, mass-produced commercial drugs.

When doctors have patients who cannot safely or effectively be treated with commercially-manufactured drugs—such as patients who require a different dosage of a drug—they often turn to their local pharmacy to compound a customized therapy for that patient. Yet the FDA is engaged in what many commentators have dubbed a “war on compounding,” as it has repeatedly brought to bear the power of the federal government on local pharmacies filling doctors’ prescriptions for compounded medicines.

The FDA’s peptide ban deprives patients of important therapies that have been widely and safely used for decades to treat a variety of conditions, ranging from Prader-Willi syndrome in children to HIV-associated lipodystrophy.  For example, one of the banned peptides, thymosin-alpha-1, has been proven safe and effective in over 80 clinical studies involving more than 230,000 patients.[1] It is an important therapy for patients with a variety of disorders involving an impaired immune response, such as sepsis, Chronic Obstructive Pulmonary Disorder (COPD), and vaccine non-responsiveness.

Dan DeNeui, Chief Executive Officer of EVEXIAS Health Solutions offered the following comment: “Patients deserve access to critical therapies that have been proven safe by studies and experience. The FDA’s decision to ban access to these well-established peptide therapies is bad science and ignores the needs of patients and the medical judgment of their physicians.” 

Andrew M. Grossman, partner at law firm Baker & Hostetler LLP and the challengers’ lead counsel, provided this comment: “The FDA fell far short of its obligation to engage in reasoned decision-making when it blocked access to these peptide therapies. A couple sentences of boilerplate language is no substitute for the careful consideration of the medical and scientific evidence that the FDA was required to perform.”

EVEXIAS Health Solutions is the leading provider of integrated wellness solutions for men and women seeking relief from symptoms of hormone imbalance. EVEXIAS Medical Centers is a leading integrative medicine clinic based in Dallas-Fort Worth with two locations boasting some of the top clinicians from across the nation. Each practitioner is highly trained in transformative integrative therapies that support optimal patient health. FarmaKeio Pharmacy Network is an industry-leading custom compounding pharmaceutical company. Committed to quality, safety and service, the company employs top experts along with the latest technologies and manufacturing processes to ensure that all its prescriptions meet the highest standards in the industry.

Tens of thousands of practitioners, many, many more patients and anyone who values high quality healthcare are impacted by this decision. You can learn more and show your support at peptidelegalfund.com. 

About EVEXIAS Health Solutions

EVEXIAS Health Solutions is an emerging leader in integrative medicine on a mission to positively impact people’s lives through the transformation of healthcare. 

Today’s healthcare system is focused on reactive sick care, costing Americans money and precious moments of their lives. It also overburdens healthcare professionals and limits the power of good medicine. That is why the EVEXIAS Health Solutions team is dedicated to redefining the practice of medicine and offering practitioners and their patients a better way to live.  

To date, the EVEXIAS team has helped thousands of practitioners across the nation enhance patient care and expand their treatment plans through advanced medical education and training from industry-leading medical practitioners, researchers, and scientists, as well as providing access to leading-edge therapies—including a proprietary methodology for pellet therapy—and technologies that support the prevention of disease and improve quality of life. Every EVEXIAS program is backed by strategic business plans and operational practices exclusively developed for private medical practices to achieve the highest level of patient experience and outcomes for the practices served.   

[1] Tuthill, C.W., et al., Thymosin [Alpha] 1 – A Peptide Immune Modulator with a Broad Range of Clinical Applications, Journal of Clinical & Experimental Pharmacology (2013).