Hiring Freeze Thaws A Bit: FDA’s Office of New Drugs Gets Broad Exemptions; Advisory Committees May Proceed

FDA’s New Drug Office: CDER Director Plans Significant Changes During Interim Period; More External Focus For Reviewers

Repeal & Replace Scorecard: Revisiting The Pharma Industry Deal On Health Care Reform

Sentinel Surveillance Expansion To Include CMS Data: Older, Sicker Population Has Higher Adverse Event Rates

Weekly Highlights: February 6 - 10

ICER In A Trump World: Value Framework Update Modifies Budget Impact To Refrain From Uptake Estimates; Does It Still Matter?

340B Freeze: “Mega-Guidance” Withdrawn, Clarity On Key Program Parameters May Be Delayed Indefinitely

“Right to Try” Gains Momentum: VP Pence Meets With Advocates On Compassionate Use; New Legislation Introduced

The End of Medicaid Rebates? State Opt-Out Urged By Former Ohio/DC Official; Medicaid Plans Pushing For Part D Model

Patient Reported Outcomes In Drug Labeling Declines Despite Broad Patient Focus In R&D; Is A Turnaround Ahead?

Generic Competition Bill To Get Energy & Commerce Attention Next Week; Markup of Insurance Reform Drafts Slated For Feb. 7

Weekly Highlights: January 30 - February 3

FDA Frozen In Time: Trump Hiring Freeze Exacerbates Existing Recruitment Challenges; CDER Has 50 Vacant Leadership Posts

AHIP Makes Recommendations For Exchanges As Alexander Targets March “Rescue” During Senate HELP Hearing

Trump Meets With CEOs: No Backing Down On Medicare “Bidding Wars”; Talks “Changing the Rules” For Drug Approvals

Regulatory Freeze Deepens: Two-For-One Executive Order Requires Clarification For FDA, CMS Most Immediately Impacted

Silicon Valley Challenge To FDA: Dramatic Overhaul Unlikely, But Nudge For New Data Collection Methods And Analytic Tools

FDA Advisory Committee Tracker: Trump Transition, Policy Review Mean Meeting Lull Continues; Opana Safety Review Set

Weekly Highlights: January 23-27

CMS Report On Rebates In Part D Sets Up Safe, Alternate Theme In Price Negotiation Debate; Parting Gift From Obama To Pharma

Executive Action on Drug Pricing: A Menu Of Possibilities – Not All Of Them Bad

Donut Hole Intrigue: HHS Nominee Price Leaves Wiggle Room On ACA Coverage Gap Discounts

Weekly Highlights: January 17-20

NIH Director Collins Stays On: Continuity For “Moonshot”– And Firewall On Potential Trump Drug Patent/Pricing Actions

FDA Multiple Endpoints Guidance: Advice, Examples on Selecting, Structuring Trials; Looking At New Statistical Approaches