FDA’s Top Drug and Food Safety Inspector Retires Amid Steep Cuts
Michael Rogers, who announced his retirement Monday, has worked at the FDA for 34 years. Also on Monday, FDA Commissioner Dr. Marty Makary announced various changes to the department. Also in the news: Labcorp, Function Health, Abbott Laboratories, and Johnson & Johnson.
CBS News:
FDA's Top Inspector Abruptly Retires
The Food and Drug Administration's top official overseeing drug and food safety inspections told staff on Monday he has decided to leave the agency, and multiple federal health officials told CBS News it comes amid frustration from inspectors with the FDA's new commissioner. Michael Rogers had worked for the FDA for more than three decades, culminating in a role as the agency's associate commissioner for inspections and investigations. Colleagues said they were surprised to learn that his final day in the office will be May 14. (Tin, 5/5)
In other pharma and tech news —
Fierce Healthcare:
Insurers Question Cell And Gene Therapy Costs As New Model Nears
In June, the Centers for Medicare & Medicaid Services (CMS) will name the participating states for the agency’s new Cell and Gene Therapy (CGT) Access Model. One state has already started participating, the CMS said, and 35 states are agreeing to participating, reported Bloomberg. These states represent about 84% of Medicaid beneficiaries with sickle cell disease. (Tong, 5/5)
Modern Healthcare:
Labcorp To Acquire Select Testing Assets From Incyte Diagnostics
Testing services company Labcorp has entered into an agreement to acquire certain clinical and anatomic pathology assets from Incyte Diagnostics, another testing company, as it seeks to expand its oncology portfolio. Financial terms were not disclosed. Assets involved in the transaction include several Incyte Diagnostics same-day testing laboratories, its main anatomic pathology lab in Spokane, Washington, and additional labs in Tukwila and Richland, Washington, as well as Missoula, Montana. (DeSilva, 5/5)
Modern Healthcare:
Function Health Acquires Ezra For MRI Body Scans
Function Health, a subscription-based health platform company, has acquired direct-to-consumer MRI scanning company Ezra, the companies said Monday. Function sells a subscription-based service that allows customers to undergo more than 160 lab tests and alerts them to potential medical problems such as cancer, thyroid issues or kidney disease. With the deal, Function is adding Ezra's full-body MRI scans to its product offerings. (Turner, 5/5)
Chicago Tribune:
Judge Throws Out Case Against Abbott Over Preterm Baby Formulas
In a win for Abbott Laboratories, a federal judge in Chicago sided with the company Friday in the case of a woman who alleged that Abbott’s formula for preterm infants led to her daughter’s death. The case had been scheduled to go to trial in the next week, and was supposed to be the first to be heard in federal court in Chicago over the issue of whether Abbott’s specialized cow’s milk-based formula for preterm babies causes a life-threatening intestinal disease called necrotizing enterocolitis (NEC). (Schencker, 5/5)
FiercePharma:
After Striking Out In Bankruptcy Court, Johnson & Johnson Goes After Expert Witness In Talc Cases
After failing to resolve tens of thousands of talc lawsuits with three unsuccessful bankruptcy attempts, Johnson & Johnson is resuscitating another strategy—seeking to discredit an expert witness who has supported claimants who say that the company’s talc products caused their cancer. In U.S. District Court in New Jersey, J&J has filed a motion to reopen a lawsuit against Jacqueline Moline, M.D. It accuses her of falsifying information used in hundreds of talc cases. (Dunleavy, 5/5)
