“Many of these patients are now left with flat feet. They have compound prescriptions that can no longer be filled,” says Scott Brunner, CEO of the Alliance for Pharmacy Compounding. “We do not believe that the FDA’s approach to date has been productive.” APC, which represents more than 600 U.S. compounding pharmacies, has written to the FDA asking it to exercise its enforcement discretion and help patients transition. requested that dispensing companies be allowed an extension of off-ramp in order to do so.
The FDA announced its intention to provide “regulatory flexibility” to compounders who continue to meet requests made before the shortage was resolved. “FDA notes that there are situations in which an outsourcing facility cannot predict when a drug shortage will be resolved, and the facility may have orders for its own compounded drug that were in progress at the time the drug was removed from the hospital. “We are aware of the FDA’s drug shortage list,” said FDA spokeswoman Amanda M. Hills. However, Hills said regulators could take action against establishments fulfilling new orders as well as establishments fulfilling old orders after a 60-day grace period.
Hallandale, one of the most popular suppliers of compounded tirzepatide for telemedicine companies, has discontinued production to comply with the law. (“Unlike others who may have taken a different position,” the company said in a letter to patients and prescribers.) The company is canceling all ongoing orders and If so, the patient was recommended to switch to combination semaglutide. It also included a link to leave comments with the regulator, encouraging patients to tell the FDA how difficult the situation is.
For now, many patients and healthcare workers remain in a precarious situation. Some telemedicine providers, such as Henry Meds, are still promoting and selling combination tirzepatide. Some companies only offer tirzepatide with additives such as: glycine, niacinamideB vitamins, and doses different from those offered in Eli Lilly’s products – attempting to argue that these formulations are different from direct copies and that it is still legally viable to formulate them. I might. But that may not stop the lawsuits. “Lilly is considering all options to address the patient safety risks posed by counterfeit, counterfeit, and illegally compounded tirzepatide,” Eli Lilly spokeswoman Antoinette Forbes said. The company said it was calling on regulators to take action against “illegal copies”.
Some companies, like Eden, have already discontinued their products. special landing page Declared combination tirzepatide to be “banned nationwide!” Ro, one of the most prominent telemedicine companies in the space, has also discontinued the product. “We are committed to ensuring we provide our patients with the best options available to maintain continuity of care. We follow FDA guidance regarding compounding and all applicable laws and regulations. ” said Ro spokesperson Nicholas Samonas. The company still sells combination semaglutide, as well as Zepbound and Wegovy. (Zepbound’s supply is still listed as “unstable” and Wegovy’s as “short.”)
Other health care providers are explicitly telling patients to stock up on their medications. For example, Emerge, a telemedicine clinic, sent an email to patients informing them that they would be offering long-term prescriptions. “As circumstances and pharmacies permit, we will offer you the option to order tirzepatide over a number of months,” the company said. However, in the long term, patients may need to switch to combined semaglutide, the paper notes.
