Today, the Obesity Action Coalition (OAC) and The Obesity Society (TOS) sent a letter to the U.S. Food & Drug Administration (FDA), along with more than 20 leading organizations and providers across the healthcare continuum, urging the agency to enforce federal regulations around compounding following the recent resolution of GLP-1 medicine shortages. Among the signatories include: the Alliance for Women's Health & Prevention, the Association of Black Cardiologists, the National Hispanic Medical Association and the National Consumers League.
The letter follows recent announcements from the FDA that Eli Lilly's tirzepatide, marketed as Zepbound for weight loss and Novo Nordisk's semaglutide, marketed as Ozempic for diabetes and Wegovy for weight loss, are no longer in shortage. In addition, a federal court in Texas recently declined to issue an injunction blocking the FDA's tirzepatide decision – underscoring the "ceasing" of all copycats by compounders.
Following the recent resolution of GLP-1 shortages, we applaud the FDA's clarification issued last week for GLP-1 compounders which indicates that outsourcing facilities making versions of tirzepatide have until March 19 to cease operations. Pharmacies must stop compounding semaglutide by April 22 while larger outsourcing facilities have until May 22, or until the district court rules on a pending injunction in the district court case – what comes first will take precedence.
The letter also acknowledges that U.S. regulations permit some compounding pharmacies to produce versions of brand-name medications under limited circumstances, including when they are in short supply or where necessary to meet the individualized needs of a specific patient. However, continued mass-production compounding of GLP-1s, in the absence of a shortage, undermines the regulatory framework designed to protect patients from potential risks associated with unapproved and unregulated drug formulations.
To address this issue, the signatories urge FDA to take the following action:
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Enforce Existing Regulations: Ensure that compounding pharmacies adhere to federal regulations by discontinuing the production of GLP-1 medications now that the shortage has been resolved.
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Monitor Compliance: Implement measures to monitor and enforce compliance during and after the grace period to prevent unauthorized compounding of these medications.
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Educate Stakeholders: Provide clear guidance to healthcare providers, pharmacists, and patients about the transition back to FDA-approved medications and the importance of obtaining treatments through appropriate channels.
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Enforce Existing Rules Against Misleading Information: Ensure that companies promoting misleading information about compounded GLP-1s are held accountable under existing regulatory authority of the FDA.
GLP-1 medications have made a transformative impact in the obesity care space. As these medicines continue to grow in popularity, regulatory action and enforcement is critically needed at the state and federal level to ensure that patients have access to safe, FDA-approved treatments."
Joseph Nadglowski, President and CEO of the Obesity Action Coalition
"Now that the GLP-1 shortage is resolved, FDA faces a critical juncture in upholding its commitment to patient safety," said Anthony Comuzzie, PhD, FTOS, CEO of TOS. "Our message is simple – FDA, the time is now to take decisive action by enforcing the existing regulatory framework around compounding."
The letter was signed by the following organizations & physicians:
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