Morning Briefing
Summaries of health policy coverage from major news organizations
FDA Finds Dozens Of Issues At Troubled Eye Drop Maker's Factory
Federal inspectors found dozens of issues at an eye drops manufacturer now linked to a fatal outbreak of drug-resistant bacteria, inspection records released by the Food and Drug Administration show, ranging from dirty equipment and clothing to missing safeguards and procedures. The FDA's findings were detailed in citations issued to Indian manufacturer Global Pharma Healthcare Pvt Ltd after an inspection from February 20 through March 2. This appears to have been the company's first visit from the FDA to their plant in India: no other inspections are on record for the site. (Tin, 4/3)
The manufacturer of eye drops that have been linked to an outbreak of serious bacterial infections in the US, including at least three deaths, did not follow proper protocol to prevent contamination of its products, according to an inspection report published Friday by the US Food and Drug Administration. The FDA visited a Global Pharma Healthcare facility in India for an inspection that started in mid-February, 2½ weeks after the company recalled EzriCare Artificial Tears due to possible contamination. (McPhillips, 4/3)
In other pharmaceutical news —
People who are overweight are flocking to the drug Ozempic to slim down. Looming is an even more powerful weight-loss treatment. The drug Mounjaro helped a typical person with obesity who weighed 230 pounds lose up to 50 pounds during a test period of nearly 17 months. No anti-obesity drug has ever safely made such a difference. In the coming months, it is widely expected to get the go-ahead from U.S. health regulators to be prescribed for losing weight and keeping it off, and some patients are already using it unapproved for that purpose. (Loftus, 4/3)
Alzheimer’s disease strikes women harder than men — over two-thirds of those who descend into dementia’s devastating twilight are female at birth. That’s likely due to biological reasons that remain poorly understood, according to the Alzheimer’s Association. One key piece of the enigma: Women lose sexual hormones such as estrogen when they undergo menopause, either naturally through the body’s decreased production or by removal of the ovaries via surgery. However, just how the loss of those hormones and the impact of hormone replacement therapy, or HRT, affects dementia risk is also unclear. (LaMotte, 4/3)
Many people say they turn to marijuana or CBD products as a way to help them sleep. But whether that edible, swallowed pill or inhaled hit soothes you to sleep may depend largely on how often you use it. (Docter-Loeb, 4/3)
