Oct 11, 2024
Click in for more news from The Hill{beacon} Health Care Health Care   The Big Story Rival manufacturers fight for the right to sell weight loss drugsThere’s a new fight brewing between manufacturers of weight loss drugs and the compounding pharmacies that have been allowed to make copycat versions during shortages.© AP Federal regulators shook up a rapidly growing pharmaceutical marketplace when they announced that tirzepatide, the active ingredient in Eli Lilly’s Mounjaro and Zepbound, was no longer in shortage after nearly two years.    When drugs are in shortage, licensed outsourcing facilities can create “compounded” versions of the drug to ensure patients have access.  Telehealth companies like Hims & Hers and Noom jumped into the market seeking to fill the void, contracting with a Food and Drug Administration-regulated compounding pharmacy to make their own versions.   But with the shortage over, the ability of compounding pharmacies to make and sell unbranded, replicated versions of these drugs came to a near halt.   Pharmacies that sold unbranded copies of those drugs are now mounting an industry-wide effort to reverse that decision. In the week since the shortage was declared over, compounding pharmacies have launched an intense campaign in protest.   One trade group has already filed a lawsuit to try to reverse the decision. Meanwhile, a similar fight over Novo Nordisk’s wildly popular drugs Ozempic and Wegovy looms.    Semaglutide, the active ingredient in both drugs, remains on the FDA’s shortage list, but compounders are bracing for when it isn’t — which could come at any time.    They argue that even though the FDA declared the shortage over, patients still have a hard time finding the drugs. That could mean some significant negative consequences, especially if patients who have been taking the drugs suddenly can’t get them anymore.    Scott Brunner, CEO of the Alliance for Pharmacy Compounding, said in a press briefing that “a lot of patients have been left flat footed” by the FDA ending the shortage.  Some patients who have been using tirzepatide may be directed to take semaglutide. But others are going to need to be transitioned to the FDA-approved drug Mounjaro or Zepbound, Brunner said.   “In many instances, it's going to take some time. They've got to get in to see their prescriber, they need to have a discussion with the prescriber about whether the FDA-approved drug is indeed the right medication for them.”   Welcome to The Hill’s Health Care newsletter, we’re Nathaniel Weixel, Joseph Choi and Alejandra O'Connell-Domenech — every week we follow the latest moves on how Washington impacts your health.   Did someone forward you this newsletter? Subscribe here.  Essential Reads How policy will be impacting the health care sector this week and beyond:  FDA declares IV fluid shortage in the wake of HeleneThe Food and Drug Administration (FDA) on Friday declared shortages of three intravenous drugs produced at a North Carolina plant that has been temporarily shut down due to the devastation from Hurricane Helene. Confirming concerns that sprang up after the storm, the FDA declared shortages of Dextrose 70% IV Solution, Lactated Ringers IV Solution and Peritoneal Dialysis Solution. Both Dextrose 70% IV Solution and Lactated Ringers …  Full Story  Iowa leads 20 states in lawsuit against Biden nursing home staffing ruleA coalition of 20 states is suing the Biden administration over a policy that mandates minimum staffing levels in nursing homes, arguing it will result in a mass shutdown of nursing homes and senior care across the country.  In a lawsuit filed Tuesday in the Northern District of Iowa, the state’s Attorney General Brenna Bird (R) said the rule should be vacated and the administration should be permanently blocked from …  Full Story  Anti-abortion PAC launches $2M ad campaign across battlegrounds The prominent anti-abortion group Susan B. Anthony (SBA) Pro-Life is launching a $2 million digital ad campaign across battleground states to counter Democrats’ push to expand access to abortion.   The partner PAC associated with SBA said the ads will run in Arizona, Georgia, Montana, North Carolina, Pennsylvania, Wisconsin and Ohio. They attack Vice President Harris as well as Democratic incumbent Sens. Sherrod Brown …  Full Story   Around the Nation Local and state headlines on health care: Now 6 California dairy workers infected with bird flu amid outbreak (USA Today)  Texas man drops wrongful death claims against women who allegedly helped ex-wife get abortion (The Texas Tribune)  Kaiser health workers prepare to strike, this time in Southern California (Cal Matters)  What We're Reading Health news we've flagged from other outlets: Worst U.S. whooping cough outbreak in a decade has infected thousands (NPR)  TikTok knew depths of app’s risk to children, court document alleges (The Washington Post)  Hurricane Milton’s lasting impact on health is just beginning, studies suggest (ABC)  What Others are Reading  Most read stories on The Hill right now: Obama sends stark warning message to Democrats Former President Obama on Thursday night did what many Democrats had been craving.  He said the quiet part out loud.  For days, Democrats … Read more Michigan newspaper issues correction after Trump claims he won man of year award A Michigan newspaper issued a correction after former President Trump cited the paper at a speech in Detroit, claiming he was Michigan’s “Man of the … Read more What People Think Opinions related to health submitted to The Hill: Big Agriculture skirts the law and the Constitution to fight animal welfare Advocacy over science: How youth gender medicine overran our institutions   You're all caught up. See you next week!  Close Thank you for signing up! Subscribe to more newsletters here The latest in politics and policy. Direct to your inbox. Sign up for the Health Care newsletter Subscribe
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