REGULATORY UPDATE LEGISLATION MANUFACTURING QUALITY Brexit: EMA Could Lose Up To Half Its US FDA Getting More Money Up Front FDA’s Revised Quality Metrics Program: Staff If It Has To Move, p. 10 Under Cures Bill Revisions, p. 5 Voluntary Now, Mandatory Later, p. 19 Pharma intelligence Pinkpink.pharmamedtechbi.comSheetVol. 78 / No. 49 December 5, 2016 informa costs, both Tom and Seema will play an in- Trump’s HHS, CMS Leadership Choices tegral role in leading that effort.” Price, a physician and current chairman of the House Budget Committee, has been Underscore Focus On ACA Reform a vocal critic of the ACA. He has sponsored CATHY KELLY
[email protected] legislation (HR 2300) that would repeal the law completely and then establish a resident-elect Donald Trump’s choices series of programs designed to broaden to lead HHS and the Centers for Medi- insurance coverage, such as refundable tax Pcare and Medicaid Services demon- credits and high-risk insurance pools. The strate his focus on implementing alterna- legislation would also seek to lower costs tives to the Affordable Care Act – and not through medical liability reforms and fur- just repealing it. ther eliminating fraud and abuse in Medi- The Trump transition team announced care and Medicaid. Nov. 29 that Rep. Tom Price, R-Ga., will be Price’s bill is not generally expected nominated as HHS secretary and a health to serve as the template for a Trump-en- care policy consultant with ties to incom- dorsed attack on the ACA but it shows his ing Vice President Mike Pence, Seema Ver- interest and engagement in developing ma, will be named CMS administrator.