FDA Warns 3 Baby Formula Makers Over Inadequate Safety Procedures
ByHeart, Reckitt/Mead Johnson Nutrition, and Perrigo Wisconsin were warned that they didn't do enough to find out why some of their products tested positive for cronobacter in instances that happened after the peak of recent supply shortages.
The Wall Street Journal:
Baby Formula Makers Get Safety Reprimands From FDA
The U.S. Food and Drug Administration sent warning letters to three baby formula manufacturers on Wednesday, saying that they had not set up adequate safety procedures to prevent any chance of contamination. The agency said in letters to ByHeart, Reckitt/Mead Johnson Nutrition and Perrigo Wisconsin that the formula makers didn’t do enough to determine the underlying causes when some of their formula tested positive for cronobacter in instances that came after the height of last year’s shortages. (Peterson, 8/30)
In other pharmaceutical industry news —
Modern Healthcare:
Walgreens CEO Rosalind Brewer Steps Down
Walgreens Boots Alliance CEO Rosalind Brewer has stepped down as head of the company and as a member of its board of directors, the company said Friday. Brewer and the board "mutually agreed" on Brewer's exit, which took effect Thursday, the company said in a news release. Walgreens said Brewer will advise the company while it conducts a search for a permanent CEO and receive a $375,000 monthly consulting fee through February. (Hudson, 9/1)
Chronicle of Philanthropy:
Medicines360’s Long And Winding, $82 Million Road To Create And Distribute $50 Birth Control
Drugs and medical devices rarely come from the nonprofit world. There are more than 2,600 for-profit pharmaceutical companies in the United States, but only three nonprofits have products on the American market. One of them is Medicines360, which in 2015 became the first nonprofit to introduce a medical device — an IUD. The genesis of the device came from an anonymous foundation that saw one of the most effective and reversible birth-control methods, the hormonal IUD, was too expensive for most women. Even insured women could be billed copays of up to $1,000. (Motoyama, 9/1)
KFF Health News:
NPR And KFF Health News Share The Story Of Two Health Heroes Who Helped Stop Smallpox
KFF Health News’ editor-at-large for public health, Céline Gounder, and Regina G. Barber, host of NPR’s podcast “Shortwave,” team up to discuss the work of two public health workers who went to great lengths — sometimes traveling by speedboat to remote islands — to root out smallpox in Bangladesh. Hear the full episode of “Speedboat Epidemiology” here — it’s Episode 4 of the latest season of the “Epidemic” podcast, “Eradicating Smallpox.” (9/5)