FDA Confirms Shortage Over For Lilly’s Weight Loss Drugs; Copies Must Come Off Market
A lawsuit forced the FDA to reassess its ruling on the availability of tirzepatide, the active ingredient in the popular drugs Mounjaro and Zepbound from Eli Lilly. As a result, the agency also told pharmacies and online companies selling off-brand copies of those drugs that they must come off the market.
NBC News:
FDA Says Lilly Weight Loss Drug Shortage Is Over After Taking A Second Look
The Food and Drug Administration said Thursday it’s standing by its earlier decision that the shortage of tirzepatide — the active ingredient in Eli Lilly’s diabetes and weight loss drugs Mounjaro and Zepbound — is over. The decision means most compounding pharmacies will need to stop making compounded versions of the drug within 90 days. (Lovelace Jr., 12/19)
AP:
FDA Says Knockoff Versions Of Lilly Obesity Drug Must Come Off The Market
Specialty pharmacies and online companies that have been selling off-brand copies of two blockbuster drugs for obesity and diabetes will need to phase out their versions next year under a federal decision issued Thursday. The Food and Drug Administration said that a nationwide shortage of Eli Lilly’s Zepbound and Mounjaro has been resolved, eliminating the need for copycat versions of the drugs that have become wildly popular with Americans trying to lose weight. (Perrone, 12/19)
The Hill:
FDA Revises 'Healthy' Food Labels To Match New Nutrition Science
A new rule from the Food and Drug Administration (FDA) will update what it means for food to be labeled “healthy” for the first time in 30 years, a move that aligns with current nutrition science and is meant to help consumers better navigate food labels. The “healthy” claim “can empower consumers” and help them identify a nutritious diet that is consistent with dietary recommendations, the agency said. (Weixel, 12/19)
Regarding the incoming Trump administration —
The New York Times:
Trump’s Return May Worsen Financial Woes For Global Health Institutions
The election of Donald J. Trump, with his mistrust of international institutions and his history of proposing deep cuts to foreign aid, has complicated a perilous landscape for global health organizations that were already in a frantic competition for sharply reduced funds. Organizations that support the cornerstone health programs to vaccinate children, treat people with H.I.V. and stop the next pandemic through disease surveillance, among other goals, are seeking billions of dollars from high-income countries. (Nolen, 12/19)
The New York Times:
Wedding Vendors Help L.G.B.T.Q. Couples Speed Up Wedding Plans Before Trump’s Next Term
Ashley Adams and Madeline Shelton didn’t have much time to pick out their wedding outfits, but they were both happy with what they wore to their Dec. 17 “microwedding,” as they called it, in Beaverton, Ore. “We didn’t get to do the whole bridal-shop experience,” said Ms. Adams, 25, a respiratory therapist in Portland, Ore. “I found my dream dress online instead.” The white gown she chose in November, after Donald J. Trump was elected president for a second term, was not the only important discovery she made online last month. (LaGorce, 12/19)
Bloomberg:
Sandoz CEO Richard Saynor On Ozempic, Big Pharma And Trump's Administration
Richard Saynor wants to transform Sandoz Group AG into a world champion in copying leading-edge drugs, including anti-obesity and biological treatments, with the goal of bringing them to the masses. After leading Europe’s largest generics company through a spinoff from Novartis AG last year, the chief executive officer has nearly doubled Sandoz’s share price. The 57-year-old Brit rejoined Basel-based Sandoz in 2019 after leaving for GSK nearly a decade earlier. (Doenecke and Edwards, 12/19)
The Washington Post:
Will RFK Jr. Be Confirmed As Health Secretary?
If no Democrats cross the aisle to vote for Kennedy, he can afford to lose only three Republican votes in the closely divided Senate. Some Republicans have embraced Kennedy’s selection to oversee the nation’s public health infrastructure, saying he will bring overdue changes as Americans struggle with a rise in chronic disease, premature deaths and other problems. Others have called on the former Democrat to explain his positions on vaccines, abortion and agriculture policy, warning they have serious questions about his planned agenda. (Diamond and Roubein, 12/20)
