Advocating for Patients as Regulatory Changes Threaten Life-Changing Treatments
COLUMBUS, Ohio, Feb. 4, 2025 /PRNewswire/ -- In an Amicus Brief submitted today in Outsourcing Facilities Association v. FDA in the U.S. District Court for the Northern District of Texas, Ivim Health raises urgent concerns over the FDA’s arbitrary deadline of March 19 that eliminates the availability of lower-cost compounded tirzepatide. Ivim asserts that the FDA’s decision may have overlooked potential adverse effects on the health of potentially millions of Americans.
“The FDA’s decision to impose a March deadline without consulting independent medical experts is deeply troubling,” said Taylor Kantor, Co-Founder & Chief Medical Officer at Ivim Health. “Medical providers know there are massive differences between safe compounds and unsafe counterfeits, which the FDA seems to have ignored. The FDA’s decision does not take into account the safety, the efficacy and the affordability of this alternative, as well as the dangers of patients turning to counterfeit and research grade products if they do not have a reliable source of medications with which to continue medical therapy.”
Pharmaceutical companies are poised to reap a substantial financial windfall, but the consequences for American patients could be dire. Millions have benefited from access to life-changing compounded medications, and the potential loss of these treatments poses severe risks to both physical and mental health across the nation.
“Our focus is on the millions of Americans that depend on these medications for their health and wellbeing. Patient safety should never be secondary to pharmaceutical company profits,” stated Anthony Kantor, Co-Founder & CEO of Ivim Health. “The FDA has the power to avert this crisis by delaying the arbitrary March deadline. The only entity that would be negatively impacted is Lilly’s bottom line, and that should not take precedence over the health of everyday Americans.”
Ivim Health is calling on the FDA to prioritize patient safety and reconsider its timeline. The organization urges stakeholders and the public to advocate for a delay in the deadline, emphasizing the necessity for thorough evaluation and input from independent medical professionals.
For more information and the full brief, please visit ivimhealth.com/news.
A preliminary injunction would give patients and medical providers valuable time to engage with FDA so FDA can make a well-informed decision concerning the future of compounding of tirzepatide.
About Ivim Health
Ivím Health is a healthcare institution employing nearly 100 medical providers, including Obesity Medicine Physicians and Nurse Practitioners, dedicated to the optimization of the health and wellness for patients managing cardiometabolic conditions including obesity. Ivim Health is focused on patient safety and outcomes as its personalized therapy via telehealth model is vital to make America healthy again. It addresses the national discussion surrounding the GLP-1 medication shortage (e.g., Ozempic®, Wegovy®, Saxenda®, Mounjaro®, Zepbound®) and alternative options like compounded formularies from 503A and 503B pharmacies.
View original content to download multimedia:https://www.prnewswire.com/news-releases/ivim-health-files-amicus-brief-fighting-for-patient-access-to-glp-1-medications-as-critical-march-deadline-looms-302367458.html
SOURCE Ivim Health
