Latest news with #OutsourcingFacilitiesAssociation
New York Post
22-05-2025
- Health
- New York Post
FDA cracking down on Ozempic copycats, potentially slimming options for consumers
Weight-loss drug users may find themselves having to scale back. The Food and Drug Administration is cracking down on copycat versions of Ozempic — the brand name of semaglutide — and Zepbound — the brand name of tirzepatide, threatening a workaround that allowed patients to access cheaper alternatives during shortages. Thursday was the final cut-off for compounded semaglutide, the active ingredient in Ozempic. mbruxelle – Advertisement Compounding pharmacies had been producing these off-brand versions under special allowances due to shortages of the FDA-approved medications. Since the FDA declared the shortages over, these flexibilities are being revoked, prompting drug compounders and telemedicine companies to scramble to find solutions to continue sales. The grace period for producing and selling compounded tirzepatide ended in March. Thursday was the final cut-off for compounded semaglutide. Advertisement These drugs mimic GLP-1 — the hormone the body naturally produces after eating — so users feel fuller for longer. The Outsourcing Facilities Association, a trade group representing compounding pharmacies, challenged the FDA's decision in court, but judges upheld the agency's authority to enforce the ban. This move is expected to tighten the supply of these medications, potentially leading to higher costs for patients who had relied on the more affordable compounded versions. Advertisement 'Patients who today can get the drug compounded for $350 a month will have no option but to pay $1,000 a month for Mounjaro or Zepbound, the Big Pharma name-brand versions that insurance usually won't cover — if they can find it, that is,' former White House Press Secretary Sean Spicer wrote in The Post of the ban. 'Simply put, tirzepatide will become unaffordable overnight for many who rely on it.' The FDA ban is expected to tighten the supply of these medications, potentially leading to higher costs for patients who had relied on the more affordable compounded versions. JHVEPhoto – Advertisement Spicer, 53, noted that he's 'tried every weight-loss drug' and 'GLP-1s have truly been a game changer' — which is why he believes this ban would greatly affect him and millions of other Americans who have come to depend on the budget-friendly drugs. 'More than 12% of US adults have used GLP-1 drugs to manage chronic conditions including diabetes, heart disease and obesity,' wrote Spicer, who is repping a telemedicine company. 'A tripling of their costs will be devastating to those who have come to rely on it.' The Wall Street Journal reported this week that compounding pharmacies and telehealth companies have slightly modified dosages, added vitamins or changed how the drugs are administered to continue selling them. They claim that the law allows for personalized medications, an interpretation rankling pharmaceutical companies. Challenges are almost certainly to come. The FDA crackdown aims to address safety concerns associated with compounded medications, which are not subject to the same rigorous approval process as their branded counterparts. The rise of telehealth companies — which critics believe do not sufficiently evaluate their patients or disclose potential side effects — adds to the concern. However, many experts believe these worries are outweighed by the health benefits of the more affordable GLP-1s, especially since the US is in the midst of an obesity epidemic. Advertisement 'The shortage is much better; insurance coverage is much worse,' Dr. Disha Narang, an endocrinologist and director of obesity medicine at Endeavor Health, told CNN. 'From a practical standpoint, patients are unable to get employer benefits for medication, which now almost upwards of 50% of our country can potentially qualify for. So it's a very strange time where you're still trying to justify to insurance companies that obesity is a chronic disease.'
USA Today
25-04-2025
- Business
- USA Today
Less expensive Ozempic, Wegovy copies restricted after federal court ruling
Less expensive Ozempic, Wegovy copies restricted after federal court ruling Show Caption Hide Caption Ozempic warning: Experts warn of side effects from weight loss drug Experts are warning of the possible side effects of popular diabetes medications such as Ozempic and Mounjaro when used for weight loss. The pharmaceutical company that makes the weight-loss drug Wegovy and the diabetes medication Ozempic secured a court victory that limits compounding pharmacies from selling versions of those popular drugs. A federal judge April 24 rejected a bid by compounding pharmacies to continue selling less expensive copies of semaglutide, Novo Nordisk's blockbuster drug sold under the brands Wegovy and Ozempic. The court ruling closes a legal window that allowed compounding pharmacies to make and sell large quantities of the lucrative weight-loss drugs. Many consumers turned to these less-expensive compounded versions of the weight-loss and diabetes drugs because they said they could not afford the brand medications. The Food and Drug Administration allows compounding pharmacies to sell copies of drugs when the medications are in short supply. In February, the FDA declared the semaglutide shortage over and set deadlines for enforcement action against compounding pharmacies and facilities that essentially copied Novo Nordisk's drug. The FDA said pharmacies or physicians could face enforcement action if they continued to make or dispense compounded semaglutide products beyond April 22. The FDA set a May 22 deadline for facilities that compound, distribute or dispense semaglutide. The industry trade group Outsourcing Facilities Association sued the FDA in U.S. District Court in Texas and sought a preliminary injunction to delay enforcement while the court case proceeded. But U.S. District Judge Mark Pittman on Thursday denied compounders' bid for a preliminary injunction. 'We are pleased the court has rejected the compounders' attempts to undermine FDA's data-based decision that the shortage of Wegovy and Ozempic is resolved,' Steve Benz, Novo Nordisk's corporate vice president, legal and general counsel, said in a statement. Outsourcing Facilities Association Chairman Lee H. Rosebush said the organization is "deeply disappointed" the court failed to consider "clear and convincing evidence" that existing supply of semaglutide doesn't meet consumers' demand. "We look forward to the opportunity to introduce this evidence again through the legal process and in discussions with the FDA," Rosebush said. "We will not stop in our efforts to ensure that patients can get access to this vital medication.' In December, the FDA declared that Eli Lilly's weight loss and diabetes medication tirzepatide, sold under the brand names Mounjaro and Zepbound, was no longer in short supply. The Outsourcing Facilities Association unsuccessfully sought a preliminary injunction to continue marketing compounded tirzepatide. March 5, a federal judge rejected the request for a preliminary injunction. That means pharmacies and facilities that sell batches of the medication could face FDA enforcement.
