Today, the Obesity Behaviors Union (OAC) and the Obesity Association (TOS) have written to the U.S. Food and Drug Administration (FDA) to urge more than 20 major organizations and providers across Healthcare Continuum to tighten federal regulations on the compound following the recent resolution of the GLP-1 healthcare shortage. Signatories include the Alliance for Women's Health and Prevention, the Association of Black Cardiologists, the National Hispanic Medical Association, and the National Federation of Consumers.
The letter follows a recent announcement from Elilily's Tilzepatide, which is sold as Zepbound for weight loss, and Elilily's Tilzepatide, which is sold as a diabetic ozempic and is sold as Wegoby for weight loss. Additionally, a federal court in Texas recently refused to issue an injunction blocking the FDA's tilzepatide decision.
Following the recent resolution on the GLP-1 shortage, we commend the FDA clarification of the GLP-1 compound issued last week. This indicates that the version that outsourcing facilities create versions of Tilzepatide will be suspended until March 19th. Drug dispensaries will need to suspend compound interest on semaglutide by April 22, but large outsourcing facilities will prevent district courts from taking priority first until May 22 or until they control injunctions in a district court case.
The letter also acknowledges that U.S. regulations allow some compound pharmacies to create versions of branded medications under limited circumstances, such as when necessary to meet the individual needs of a particular patient. However, in the absence of shortages, continuing mass production formulations of GLP-1 undermines a regulatory framework designed to protect patients from the potential risks associated with unapproved, unregulated drug formulations.
To address this issue, signers will encourage the FDA to take the following actions:
Implement existing regulations: Now that the shortage is resolved, make sure that combined pharmacies comply with federal regulations by halting production of GLP-1 drugs.
Monitor compliance: Implement measures to monitor and implement compliance during and later grace periods to prevent unauthorized conjugation of these drugs.
Educate stakeholders: Provide clear guidance to healthcare providers, pharmacists and patients on the transition to FDA-approved medications and the importance of receiving treatment through appropriate channels.
Enforce existing rules for misleading information: Ensure that companies promoting misleading information about composite GLP-1 are accountable based on existing FDA regulators.
GLP-1 drugs had a transformative impact on the obesity care space. Due to the growing popularity of these medicines, regulatory action and enforcement at the state and federal levels are highly required to ensure patients have safe and access to FDA-approved treatments. ”
Joseph Nadgrowski, president and CEO of Obesity Action Coalition
“Now that the GLP-1 shortage has been resolved, the FDA is facing a critical time in maintaining its commitment to patient safety,” said Dr. FTOS, CEO of TOS. “Our message is simple. The FDA, now is the time to take decisive action by implementing existing regulatory frameworks on compound interest.”
The letter was signed by the following organizations and doctors:
