FDA Aims To Yank From The Market A Common But Ineffective Decongestant
The ingredient, called oral phenylephrine, is commonly used in cough and cold medicines. Also: Monkeys are on the loose from a South Carolina research facility; a North Carolina hospital files for bankruptcy; a Maine hospital ends labor and delivery services; a historic fetal surgery at Children's Hospital of Philadelphia; and more.
The Food and Drug Administration announced Wednesday that it would seek to pull a widely used ingredient in cough and cold medicines from the market, after the agency's scientists concluded that the oral version of the drug is ineffective as a nasal decongestant. The FDA's proposal comes more than a year after the agency's outside advisers voted against continued use of the ingredient, called oral phenylephrine, citing concerns with the initial data used to support its approval and new data questioning its effectiveness. (Tin, 11/7)
Police in South Carolina are on the hunt for 43 rhesus monkeys that escaped from a research facility on Wednesday. The 鈥渟kittish鈥 animals, belonging to local primate research company Alpha Genesis, have been wandering the Yemassee area for about a day, according to a Thursday press release from the Yemassee Police Department. ... The escaped rhesus monkeys are all young and female, weighing about six or seven pounds each. Because of their age and size, the monkeys have not yet been tested on and carry no disease, according to police. The Alpha Genesis facility breeds cynomolgus, rhesus and capuchin monkeys for government, university and private industry research projects. It has worked on vaccine development for decades, including projects related to the coronavirus vaccine. (Lee, 11/7)
In other health industry developments 鈥
Plymouth, N.C.-based Washington Regional Medical Center sought Chapter 11 protection Oct. 29 to help the hospital restructure its finances while ensuring care to patients. The 25-bed critical access hospital will remain open following the filing with daily operations remaining uninterrupted and no effect on employees and patients, according to a news release shared with Becker's.聽 (Ashley, 11/7)
Belfast-based MaineHealth Waldo Hospital has shared plans to restructure its obstetrics and end its labor and delivery services, effective April 1, 2025, according to a Nov. 7 news release shared with Becker's.聽The hospital, which is part of Portland-based MaineHealth, will still offer and expand comprehensive pre- and post-natal care and partner with MaineHealth Pen Bay Hospital and other local hospitals for labor and delivery services.聽 (Ashley, 11/7)
The Children's Hospital of Philadelphia has successfully performed a historic fetal surgery to remove a heart tumor, saving the life of a baby from Tennessee. When Brailey Valenzuela was 24 weeks pregnant, an ultrasound showed her baby had a deadly heart tumor. ... Brailey Valenzuela became the fourth patient at CHOP to successfully undergo this type of fetal heart surgery. (Stahl and Nau, 11/7)
Private equity firms are shifting their focus from providers to healthcare information technology and pharmaceutical services. State and federal regulatory scrutiny has deterred private equity investment in healthcare providers, PitchBook analysts said in the company鈥檚 latest healthcare services report. But regulatory oversight of healthcare-related private equity deals has slightly cooled as certain state bills stalled in the 2024 legislative session, and the report says analysts expect more private equity activity through the rest of the year. (Kacik, 11/7)
Aetna and OptumHealth have agreed to settle a class-action lawsuit alleging they used a 鈥渄ummy code鈥 to inflate workers' medical expenses. A settlement would put to rest a nine-year-long dispute between the companies and plaintiff Sandra Peters, who alleges Aetna and OptumHealth failed to uphold their fiduciary duties under the Employee Retirement Income Security Act of 1974, which governs large-group health plans such as employee benefits. (Tepper, 11/7)
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Watchdog Calls For Tighter Scrutiny Of Medicare Advantage Home Visits
A new federal watchdog audit is ratcheting up pressure on government officials to crack down on billions of dollars in overcharges linked to Medicare Advantage home visits. But so far, the Centers for Medicare & Medicaid Services has rejected a recommendation from the Health and Human Services Inspector General to limit payments stemming from house visits that don鈥檛 result in any medical treatment 鈥 a potential red flag that may signal overcharges. (Schulte, 11/8)
Also 鈥
A progress report from the Centers for Disease Control and Prevention (CDC) shows that rates of healthcare-associated infections (HAIs) at US hospitals fell in 2023. The declines, primarily seen in acute-care hospitals, reflect a continuing downward trend in the wake of the COVID-19 pandemic, with some HAIs falling below pre-pandemic levels. (Dall, 11/7)