Latest news with #MarkPittman
Yahoo
07-05-2025
- Business
- Yahoo
US judge sides with FDA's removal of Lilly's weight loss drug from shortage list
By Patrick Wingrove (Reuters) -A U.S. federal judge has sided with a U.S. regulator's decision last year to take Eli Lilly's blockbuster weight loss and diabetes drugs Zepbound and Mounjaro off a list of medicines in short supply, a ruling that could dash patients' hopes of regaining access to cheaper copies of the popular therapies. The U.S. Food and Drug Administration decision was also a blow to compounding pharmacies that had been allowed to produce hundreds of thousands of doses of copies of obesity drugs only while the FDA said there was a shortage of them. U.S. District Judge Mark Pittman in Texas issued the order on Wednesday under seal in response to an October lawsuit from a compounding industry group against the FDA's edict. The judge in March refused to allow compounding pharmacies to keep making copies of Zepbound and Mounjaro while the case was ongoing. All compounding pharmacies, including larger so-called outsourcing facilities, were required to cease making copies of the drugs on March 19. They might have been able to restart production had the judge ruled the other way. The judge last month also rejected a bid by compounding pharmacies to keep making copies of Novo Nordisk's, popular diabetes and weight-loss drugs Ozempic and Wegovy while a legal challenge over drug shortages unfolds. Pittman has yet to issue a ruling in that case. In their lawsuit against the FDA and Lilly, the compounders said the FDA relied solely on statements by Lilly in determining that there was no shortage, and that patients were still often unable to access the drugs. Outsourcing Facilities Association Chairman Lee Rosebush said he was disappointed with the court's decision, adding that "drug shortage determinations affect patient access to medical treatment and should be based on sound reasoning and verifiable data, not the say-so of self-interested manufacturers seeking to push competitors out of the market".. The FDA and Lilly did not immediately respond to requests for comment. (Reporting by Patrick Wingrove; Editing by David Gregorio)
Yahoo
25-04-2025
- Business
- Yahoo
Copycat Ozempic makers just lost a big court fight
A federal judge in Texas handed Novo Nordisk (NVO) a big win late Thursday in its battle against cheaper versions of its blockbuster drugs Ozempic and Wegovy, rejecting a bid by compounding pharmacies to keep making the drugs while a legal challenge moves forward. In a sealed order U.S. Judge Mark Pittman denied a request for preliminary injunction a trade group representing compounding pharmacies that would have prevented the Food and Drug Administration from taking action against its members for making knock-off versions using semaglutide, the active ingredient in the weight loss drugs. Small-scale compounders must now immediately stop making their versions of Ozempic and Wegovy. Larger, federally licensed compounders have until May 22 to keep producing the copycats. The popular drugs had been in short supply for some two years, which led the FDA to declare a shortage, thus allowing pharmacists to legally make compounded versions of the patented medications. Many telehealth companies also jumped into the market with compounded drugs. However, in February the FDA determined that the semaglutide shortage was over, leading to the lawsuit by Outsourcing Facilities Association. '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,' said Steve Benz, Corporate Vice President, Legal and U.S. General Counsel, Novo Nordisk in an statement. He said that the company will continue driving legal actions forward 'and escalate our efforts as necessary, while closely engaging with regulators and law enforcement.' Compounding pharmacies make drugs tailored to individual prescriptions for a specific patient and are largely regulated by states rather than the FDA. Eli Lilly (LLY) has also taken aggressive legal action against compounding pharmacies, and on Wednesday filed lawsuits against four telehealth companies that offer cheaper versions of its weight loss drugs Mounjaro and Zepbound. For the latest news, Facebook, Twitter and Instagram.
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.
CNBC
25-04-2025
- Business
- CNBC
Novo Nordisk scores major legal win that bars many compounded versions of Wegovy, Ozempic
Novo Nordisk scored a huge legal victory that largely restricts compounding pharmacies from marketing or selling cheaper, unapproved versions of the drugmaker's blockbuster weight loss drug Wegovy and diabetes treatment Ozempic. A federal judge in Texas late Thursday rejected a bid by compounding pharmacies to keep making copies of Ozempic and Wegovy while a legal challenge over the shortage of those drugs unfolds. That came in response to a February lawsuit from a compounding trade group against the Food and Drug Administration's determination that the active ingredient in those drugs, semaglutide, is no longer in shorter in the U.S. Patients flocked to the cheaper copycats when Ozempic and Wegovy were in short supply over the last two years due to skyrocketing demand, or if they didn't have insurance coverage for the costly treatments. During FDA-declared shortages, pharmacists can legally make compounded versions of brand-name medications. Many telehealth companies, such as Hims & Hers, also offered those copycats. But drugmakers and some health experts have pushed back against the practice because the FDA does not approve compounded drugs, which are essentially custom-made copies prescribed by a doctor to meet a specific patient's needs. "We are pleased the court has rejected the compounders' attempts to undermine FDA's data-based decision that the shortage" of semaglutide is resolved, said Steve Benz, Novo Nordisk's corporate vice president, legal and U.S. general counsel, in a statement. "Patient safety remains a top priority for Novo Nordisk and the extensive nationwide legal actions we have taken to protect Americans from the health risks posed by illegitimate 'semaglutide' drugs are working," he said, referring to the company's more than 100 lawsuits against compounding pharmacies and other entities across 32 states. On Thursday, U.S. District Judge Mark Pittman specifically denied the Outsourcing Facilities Association's bid for a preliminary injunction that would have prevented the FDA from taking action against its members for making copies of semaglutide. That decision upholds the FDA's previous determination that the semaglutide shortage in the U.S. is over and means the FDA can now immediately go after so-called 503A pharmacies that are making compounded versions of semaglutide according to individual prescriptions for a specific patient. Those pharmacies are largely regulated by states rather than the FDA. Those pharmacies make compounded drugs according to individual prescriptions for a specific patient and are largely regulated by states rather than the FDA. The decision also means the FDA can start targeting federally regulated 503B pharmacies, which manufacture compounded drugs in bulk with or without prescriptions, after May 22. The agency's actions can include product seizures and warning letters to pharmacies. The decision on Thursday follows another win for Novo Nordisk. A different federal judge in Texas earlier this week ruled in favor of the drugmaker against a 503A pharmacy, MediOak Pharmacy, permanently prohibiting the business from marketing or selling compounded semaglutide. Novo Nordisk and Eli Lilly have aggressively cracked down on compounding pharmacies over the last two years as they benefit from the soaring popularity of their weight loss and diabetes drugs. Eli Lilly has gone through a similar legal process with tirzepatide, the active ingredient in its weight loss drug Zepbound and diabetes treatment Mounjaro. The FDA declared the U.S. shortage of tirzepatide over last year, prompting the same compounding trade group to sue the FDA over the drug. In March, a federal judge denied the compounding group's request for a preliminary injunction on the FDA's enforcement against its members for making copies of Mounjaro and Zepbound. The compounding group has appealed.
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Business Standard
25-04-2025
- Business
- Business Standard
US judge denies injunction, restricts copies of weight-loss drug Ozempic
A US judge on Thursday rejected a bid by compounding pharmacies to keep making copies of Novo Nordisk's popular diabetes and weight-loss drugs Ozempic and Wegovy while a legal challenge over drug shortages unfolds, court records showed. The decision came in response to a February lawsuit from a compounding industry group against the US Food and Drug Administration's decision that there was no longer a shortage of the medicines' active ingredient, semaglutide. They had been allowed to produce hundreds of thousands of doses of copies of Novo's obesity and diabetes drugs only while the FDA said they were in short supply. Many of these are sold by large telehealth companies like Hims & Hers. US District Judge Mark Pittman in Texas denied compounders' bid for a preliminary injunction, according to the court docket. Pittman filed his legal reasoning under seal, but by denying the injunction request, a May timeline set by the FDA for when large US compounders will have to exit the market remains in place. It also follows a decision the judge made earlier this year refusing to allow compounding pharmacies to keep making copies of Eli Lilly's weight-loss and diabetes drugs Zepbound and Mounjaro. The FDA and Novo Nordisk did not immediately respond to requests for comment. In a previous court filing, Novo defended the FDA's decision, saying the agency had concluded that the company's drug supply outweighed any reasonable measure of projected demand. Lee Rosebush, chairman of lead plaintiff Outsourcing Facilities Association, told Reuters that his organization had presented evidence of an ongoing semaglutide shortage that was obtained after the lawsuit was filed. However, Rosebush said the judge declined to consider it. "We are obviously disappointed with this initial decision and believe the data shows that there is still a shortage of these products," he said. The FDA had said it would not take any enforcement action against compounders before the court ruled. The regulator has given larger so-called outsourcing facilities, which make compounded drugs in bulk and are regulated by the agency, until May 22. Smaller compounding pharmacies, which make drugs to fill prescriptions for individual patients and are primarily overseen by US states, must immediately cease making copies of semaglutide.
