Morning Briefing
Summaries of health policy coverage from major news organizations
FDA: Baby Formula Factory Had Cleanliness Problems Before Recall
Bloomberg: Abbott Infant Formula Plant Found Unsanitary Before Recall
Food and Drug Administration inspectors found unsanitary conditions at an Abbott Laboratories plant in Michigan that makes infant formula in September, five months before the company conducted a recall of products associated with the deaths of two babies. The FDA’s inspection started on Sept. 20, according to a report posted on the regulator’s website on Tuesday. The same day, Minnesota health officials told the agency about the case of an infant who fell ill with a dangerous bacteria called chronobacter after consuming infant formula. (Edney, 3/22)
AP: FDA Details Problems At Plant Behind Recalled Baby Formula
Baby formula maker Abbott failed to maintain sanitary conditions and procedures at the Michigan manufacturing plant recently linked to a cluster of infant illnesses, according to findings released Tuesday by federal safety inspectors. The Food and Drug Administration posted its initial inspection findings from the Abbott plant that’s been tied to several infant hospitalizations, including two deaths, due to a rare bacterial infection. Abbott recalled various lots of three popular powdered infant formulas in mid-February. FDA inspectors have been on-site inspecting the Sturgis, Michigan, facility since late January. (Perrone, 3/22)
In other news about infant nutrition —
Fortune: ByHeart’s Mia Funt On The Launch Of Its Next-Generation Infant Formula, Raising $190 Million In Funding And The Future Of Baby Nutrition
Mia Funt started ByHeart five years ago, one year after her first daughter, Neve, was born. She, like so many parents, approached both breastfeeding and formula feeding Neve with insecurity (how to do it, when to do it, when to NOT do it, etc). When it came to formula, the options were confusing and the nutrition was unclear. She ended up feeling like she was compromising any time she couldn’t breastfeed. “I had ALL of these questions when I stood in front of a shelf of formulas, and I couldn’t find one that I would feel confident feeding my baby,” she starts her story. (Butkovic, 3/23)
And Pfizer issues a recall —
NPR: Pfizer Launches A Recall Of Blood Pressure Drugs Due To A Potential Carcinogen
Pfizer Inc. is recalling a blood pressure drug due to elevated levels of a potential cancer-causing impurity. The company warned consumers on Monday of several tainted lots of Accuretic and two other versions of the drug – Quinapril and hydrochlorothiazide tablets – because of the presence of a nitrosamine above the Acceptable Daily Intake level. "Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines," according to the Food and Drug Administration. (Romo, 3/22)
In other pharmaceutical and biotech industry news —
The New York Times: Another Theranos Trial Begins, This Time Without the Fanfare
A small group with cameras milled around on the sidewalk. Inside, a smattering of reporters stared into their phones. And when the defendant walked in, flanked by lawyers, barely anyone noticed. So began the federal trial on Tuesday of Ramesh Balwani, the tech executive who is accused of defrauding patients and investors about Theranos, the blood testing start-up he helped build. Mr. Balwani, who goes by Sunny, has pleaded not guilty to a dozen charges of wire fraud and conspiracy to commit wire fraud. (Woo and Griffith, 3/22)
Axios: Private Equity's Pandemic-Era Health Care Push Into Pharmaceuticals And Medical Devices
Private equity firms invested nearly $70 billion in the life sciences and medical device industries last year — a sign that the pandemic's disruptions didn't cool interest in the sectors, according to a new report by the American Investment Council. The influx of capital could help bring more lifesaving drugs and medical technologies to market. But private equity's growing presence in health care isn't always viewed positively, particularly when it's associated with price increases or reduced access to care. (Owens, 3/23)
