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)
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
35 minutes ago
- Yahoo
Recall issued for potential significant risk with use of Zicam, Orajel swabs. What to know
A "potential microbial contamination" has lead to the recall of several cold nasal swabs and baby teething swabs, according to an announcement from the U.S. Food and Drug Administration June 9. All lots of Zicam Cold Remedy Nasal Swabs, Zicam Nasal AllClear Swabs, and Orajel Baby Teething Swabs have been recalled due to the potential contamination. The swabs can "potentially present a significant risk to the health and safety of consumers including serious and life-threatening blood infections." Here's what you should know. Church & Dwight Co. is recalling all lots of Zicam Cold Remedy Nasal Swabs, Zicam Nasal AllClear Swabs, and Orajel Baby Teething Swabs due to potential microbial contamination identified as fungi in cotton swab components, according to a June 9 news release. The recall is limited exclusively to Zicam and Orajel swab products. All other Zicam and Orajel products, including Zicam RapidMelts, are not affected by the recall, the news released from the FDA said. As of June 9, "no serious adverse events" associated with the affected product have been reported, the FDA said. Recalled Zicam and Orajel swabs included in the recall are: Zicam Cold Remedy Nasal Swabs, all lots: A zinc-free, homeopathic cold remedy swab designed to shorten the duration of the common cold. Zicam Nasal AllClear Swabs, all lots: A nasal cleansing swab product (discontinued in December 2024). Orajel Baby Teething Swabs, all lots: Pre-moistened swabs designed to soothe teething discomfort in infants and toddlers. "Swabs found to contain microbial contamination can potentially present a significant risk to the health and safety of consumers including serious and life-threatening blood infections in users whose nasal mucosa may be compromised due to inflammation and mechanical injuries. "The risk is highest — potentially severe or life-threatening — among children and individuals with compromised immune systems or other underlying medical conditions." The recalled products were distributed nationwide in the United States and in Puerto Rico. Consumers who have purchased any of the recalled products should stop using the product immediately, the FDA said. Go to or call the Consumer Relations team at 800-981-4710 for a full refund. This article originally appeared on Treasure Coast Newspapers: Zicam recall: cold nasal swabs. Also Orajel baby teething swabs
Yahoo
41 minutes ago
- Yahoo
India faces two years of sugar surplus, growers and officials say
By Rajendra Jadhav SATARA, India (Reuters) -India is set to produce surplus sugar for at least two consecutive years, as millions of farmers expand the area under sugarcane cultivation amid ample rainfall, boosting crop yields, growers and industry officials said. The rebound in production would allow the world's second-largest sugar producer to increase exports in 2025/26, they said, after poor rainfall cut sugarcane yields and led to two years of export restrictions. "Sugarcane usually gives us good returns, but sometimes we can't plant it due to a lack of water," said Umesh Jagtap as he planted the crop on a three-acre plot in Maharashtra, a leading sugar producing state in the west. "This year, we had heavy rain in May, and the forecast says more rain is on the way. So we're planning to plant more than usual." Farmers from Maharashtra and neighbouring Karnataka struggle to irrigate their sugarcane crop in May. This year, however, Maharashtra and Karnataka received 1,007% and 234% more rainfall than average, respectively. The rainfall will benefit the crop to be harvested in the 2025/26 season, starting October, and will also support planting for the 2026/27 harvest, said Prakash Naiknavare, managing director of the National Federation of Cooperative Sugar Factories (NFCSF). Sugarcane typically takes 10 to 18 months from planting to harvest. As a result, farmers who began planting this month are expected to harvest their crop during the 2026/27 season. The NFCSF estimates gross sugar production in 2025/26 to rise by nearly a fifth from a year earlier, reaching 35 million metric tons. For the 2024/25 marketing year to September, India's net sugar production is expected to fall below consumption for the first time in eight years. This decline stems from a 2023 drought that hit sugarcane planting and forced India to prohibit sugar exports in 2023/24 and allowing merely 1 million tons in 2024/25. India was the world's No. 2 sugar exporter during the five years to 2022/23, with volumes averaging 6.8 million tons annually. "Looks like production is set to bounce back strongly, so New Delhi will probably have no trouble allowing exports of over 3 million tons in the next season starting October," said a Mumbai-based trader with a global trade house.
The Hill
43 minutes ago
- The Hill
Fungal concerns spark nationwide recall of Zicam, Orajel products
(WJW) – Swabs under two well-known brand names have been recalled over potential fungi-related microbial contamination. According to the Food and Drug Administration (FDA), Church & Dwight Co., Inc. is voluntarily recalling some Zicam and Orajel products because fungi could be present in the items' cotton swab components. The recalled products include all lots within expiry of Zicam Cold Remedy Nasal Swabs, Zicam Nasal AllClear Swabs, and Orajel Baby Teething Swabs to the consumer level. Consumers are advised to 'immediately' stop using the recalled products. Major grocery chain slashing prices for the summer 'Swabs found to contain microbial contamination can potentially present a significant risk to the health and safety of consumers including serious and life-threatening blood infections in users whose nasal mucosa may be compromised due to inflammation and mechanical injuries,' reads the recall alert. 'The risk is highest (potentially severe or life-threatening) among children and individuals with compromised immune systems or other underlying medical conditions.' The FDA said, so far, no serious adverse events associated with the affected product have been reported. The recalled products were distributed nationwide in the United States and in Puerto Rico, said the FDA. Here are the specific details to check for: Zicam® Cold Remedy Nasal Swabs, with UPC 732216301205, all lots: A zinc-free, homeopathic cold remedy swab designed to shorten the duration of the common cold. Zicam® Nasal AllClear Swabs, with UPC 732216301656, all lots: A nasal cleansing swab product (discontinued in December 2024). Pre-moistened swabs designed to soothe teething discomfort in infants and toddlers. You can view images of the recalled products in the slideshow below: 'This recall is limited exclusively to Zicam and Orajel swab products. All other Zicam and Orajel products, including Zicam RapidMelts, are not affected by this recall,' states the FDA on its website. Consumers can Click here or call (800) 981-4710 for refund details.
