Today, the OAC, OAC, and the Obesity Association (TOS) sent letters to the US Food and Drug Administration (FDA) and urged the federal regulations for compounds in accordance with the recent resolution of GLP-1 medical needs with more than 20 major organizations and providers throughout the medical continuum. The signators are as follows. Women’s Health and Prevention Alliance, Black Heart Scholars Association, National Hispanic Medical Association and National Consumers League.
According to a recent announcement from the FDA, ELI LILLY’s TIRZEPATIDE is a Zepbound for weight loss and an ELI LILLY’s Tirzepatide, which is sold as a Semaglutide of Novo Nordisk, is no longer lacking. Semaglutide and Semaglutide of Semaglutide and Novo Nordisk. The Texas federal court recently rejected the prohibition order to prevent the FDA’s Tirzepatide decision, emphasizing the “stop” of all imitation carts by the complex.
After the recent GLP-1 tribe was resolved, we applauded the FDA’s explanation last week about GLP-1 Complex. The pharmacy should stop the semagluide complex by April 22, and the larger outsourcing facility will be prioritized until May 22 or until the District Court prescribes the rules for the suspension of the district court.
The letter also admits that in accordance with the US regulations, some complex pharmacies can produce a brand of brands in limited situations, including cases needed to meet the lack of supply or meet the individualized demands of a particular patient. However, when there is no shortage, the continuous mass production compound of the GLP-1 weakens the regulatory frameworks designed to protect the patient from the potential risks associated with unlimited and uncontrollable drug formulations.
To solve this problem, the signer calls for the FDA to take the following measures:
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Existing regulations: Since the tribe has been resolved, the complex pharmacy must comply with the federal regulations by stopping the production of GLP-1 drugs.
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Compliance Monitoring: During the grace period and the actions of monitoring and implementing compliance, it prevents the unauthorized complex of these drugs.
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Stakeholder Education: Provide clear guidance to medical service providers, pharmacists, and patients for the importance of gaining treatment through the transition to the FDA approval drug and the appropriate channel.
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Existing rules for information that is misunderstood. A company that promotes misunderstandings about the Combined GLP-1 will be responsible for the FDA’s existing regulatory agency.
GLP-1 drugs had a variant of obesity treatment space. As the drug continues to grow, regulatory measures and execution are important at the state and federal levels so that patients are safe and access to FDA approval. “
Joseph nadglowski, the president and CEO of Obesity
Dr. Anthony Comuzzie, the CEO of TOS, said, “Since the GLP -1 shortage has been resolved, the FDA is faced at an important point in supporting the promise of patient safety.” Our message is simple -FDA, now implementing an existing regulatory framework for complexes by implementing a decisive measure by implementing an existing regulatory framework for complexes. It’s time to take. ”
This letter was signed by the following organizations and doctors.
