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Around the nation: FDA confirms Mounjaro, Zepbound no longer in shortage


Last month, FDA reaffirmed that Eli Lilly's diabetes and weight-loss drug tirzepatide is no longer in shortage, a decision that initially sparked pushback from some healthcare providers and pharmacies, in today's bite-sized hospital and health industry news from Illinois and Maryland. 

  • Illinois: Last month, Medline Industries reported that it submitted plans to the Securities and Exchange Commission for a proposed initial public offering (IPO). So far, the number of shares and the price range of the proposed offering are still being determined. "No final decision about the IPO has been made, and any IPO would be subject to various factors, including market conditions," a Medline spokesperson said. "Should the process move forward, the company will share more information publicly in accordance with appropriate guidelines and timelines." According to Bloomberg, an IPO could raise over $5 billion, with Goldman Sachs, Morgan Stanley, JPMorgan Chase, and Bank of America likely to participate. Last July, Medline was also in early talks with banks about an IPO that could potentially value it at up to $50 billion. (Dubinsky, Modern Healthcare, 12/19)
  • Illinois: According to a report from the nonprofit Food Animal Concerns Trust (FACT), five out of 20 of the largest restaurant chains in the United States received failing grades when it came to having policies that restrict the overuse of antibiotics in the meat they serve customers. In the report, researchers graded 20 chains based on their policies and actions concerning antibiotic use in meat, such as beef, turkey, pork, and chicken. Five chains — Olive Garden, Dairy Queen, Arby's, Little Caesars, and Sonic — did not have any public policies to ensure their meat suppliers complied with FDA regulations to address antibiotic resistance. Of the other chains, only two, Chipotle and KFC, received an A+ for implementing policies that restrict the use of medically important antibiotics to treat sick animals for each meat served. Most of the chains did not have publicly available policies for antibiotic use in beef, pork, or turkey, but they did have policies for chicken suppliers. "Food company action can have a positive impact as illustrated by the U.S. chicken industry, which has drastically reduced its antibiotics use, but the other meats sectors are resisting change," said Steve Roach, who heads FACT's safe and healthy food program. (Silverman, STAT+ [subscription required], 12/2)
  • Maryland: Last month, FDA reaffirmed that Eli Lilly's diabetes and weight-loss drug tirzepatide is no longer in shortage. The agency initially announced in October that the drug was no longer in shortage, but faced pushback from compounding pharmacies, which would no longer be able to fill prescriptions for compounded versions of the drug. In response to the decision, the Outsourcing Facilities Association (OFA) sued FDA, saying that its decision to remove tirzepatide from the shortages list was "reckless and arbitrary." After reevaluating its decision, FDA later reaffirmed that tirzepatide was no longer in shortage and that Eli Lilly demonstrated its ability to meet demand for the drug. FDA also noted that Eli Lilly has sufficient reserves of the drug and is increasing production so that "supply will meet or exceed projected demand." According to FDA, it will allow state-licensed compounders to dispense tirzepatide for another 60 days, with federally licensed compounders getting 90 days, before it takes enforcement action. Meanwhile, Eli Lilly has asked to join FDA in opposing OFA's lawsuit, saying that it could not be sure the agency would appeal if the court ruled against the company. (Gilbert, Washington Post, 12/20; Pierson, Reuters, 1/2) 

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