FDA Chief To Launch New Drug Office As A First Step Toward A Systematic Overhaul Of How Medicines Are Reviewed
The Office of Drug Evaluation Science is going through the final stages of review and FDA Commissioner Scott Gottlieb expects to start the office in the first half of this year. Gottlieb will outline his plan via video-conference at the annual J.P. Morgan Healthcare Conference.
Stat:
FDA Plans To Create A New Office To Leverage Cutting-Edge Science
The Food and Drug Administration plans to create a new office to improve the review of new medicines — one that will develop a standardized approach to using personalized medicine, digital data, and patients’ own reports, according to Commissioner Scott Gottlieb. Gottlieb will outline the plan for the new 52-person group, called the Office of Drug Evaluation Science (ODES), as part of a talk at the annual J.P. Morgan Healthcare Conference on Tuesday. Because of the government shutdown, he will deliver the talk via videoconference. (Herper, 1/7)
Modern Healthcare:
On The Ground At J.P. Morgan's Health Conference
Kent Thiry, CEO of the dialysis provider DaVita, told a breakout session audience on Monday evening that the company is working to close on the sale of its medical group to UnitedHealth Group in the first quarter of 2019. He said the federal government shutdown could complicate the deal. ... Last month, DaVita announced it had agreed to lower the price on its medical group, DaVita Medical Holdings, to $4.34 billion, from $4.9 billion. (Bannow, 1/7)
In other news on the agency —
Stat:
Former FDA Chiefs Agree Agency Needs Independence, But Differ On Details
Nearly every person who’s run the Food and Drug Administration in recent history agrees the agency should break free from its political supervisors — a rare consensus from commissioners who served under Republican and Democratic administrations alike. In two papers published Monday, all seven of the FDA’s most recent commissioners wrote that the current setup — in which the agency is a mere subdivision of the Department of Health and Human Services — interferes with the ability of its scientists to protect the health of the public. (Swetlitz, 1/7)