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In Staff-Wide Email, Woodcock Details Plans For Drug Center Reorg

FDA drug center Director Janet Woodcock on Thursday (July 19) provided her staff with details on the proposed reorganization of the center, saying the plan, which has been submitted to HHS for approval, involves structural changes within the center's four offices.

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CMS opened a new public comment period Thursday (July 19) on Kentucky’s proposal to add work requirements and other new coverage restrictions to its Medicaid program -- a step the agency hopes will allay the concerns of a federal judge who blocked the proposal from taking effect last month.

Bayer will stop selling and distributing its permanent birth control device Essure after Dec. 31 citing commercial reasons, FDA announced Friday (July 20), coming three months after the agency limited Essure to prescription-only in the face of years of adverse events and congressional pressure to step up its oversight.

CMS is creating a new position of Chief Health Informatics Officer to oversee the agency’s policies on information technology and data sharing, the agency said Thursday (July 19), and the official, while yet to be chosen or their specific responsibilities refined, likely will play a large role in CMS’ planned overhaul of the electronic health record incentive program formerly known as the meaningful use program.

FDA sent shock waves through the pharmaceutical industry Thursday (July 19) by announcing it will study how to import drugs as a response to price spikes.

The White House Office of Management and Budget is reviewing an HHS Inspector General proposal to both remove safe harbor protections and create new ones for drug rebates, according to the title of the proposed rule.

FDA released a long-awaited Biosimilars Action Plan Wednesday (July 18) that promises new development tools for biosimilars makers, additional educational resources and a public hearing dedicated to biosimilar competition, among other initiatives.

The House Energy & Commerce health subcommittee on July 25 will hear from FDA Commissioner Scott Gottlieb and National Institutes of Health Director Francis Collins about the work being done to implement provisions of the 21st Century Cures Act, the subcommittee announced Wednesday (July 18).

HHS Secretary Alex Azar announced Wednesday (July 18) that Center for Medicare and Medicaid Innovation (CMMI) Director Adam Boehler will also begin serving as senior advisor for Value-Based Transformation and Innovation.

FDA approved new uses of a cancer drug using two new pilot review programs that aim to streamline the review of cancer drugs and improve the standards for evaluating safety and efficacy, the agency announced Wednesday (July 18).