“Right To Try” Contradicts FDA’s Mission, Former FDA Official Says; Federal Legislation Risks Eroding Efficacy Standard

Weekly Highlights: March 6-10

Opana ER Review Shows Limits Of Abuse-Deterrent Tech As Solution To Opioid Abuse; Product Unlikely To Be Pulled By FDA

Orphan Drug Act Review: Pricing Issues, OPEN Act Reflect Two Very Different Ideas For Reforms To Rare Disease Development

Christmas In July? PDUFA VI Add-Ons May Include Right-To-Try Legislation And Priority Review Vouchers For Generic Drugs

Drug Pricing Sideshow: Trump/Cummings Talk Fits 2017 Themes; Risk To Industry Low, But Rises If Bipartisan Approach Takes Hold

FDA Broadens Role for Controlled Substance Staff Within CDER, Abuse-Related Information To Be Reviewed

AHCA Per Capita Approach to Medicaid Retrenches Coverage Expansion; Drug Price Actions Will Come On Separate Track

Patient-Focused Drug Pricing & Insuring: ICER Implements New Framework For MS Reviews, Value-Based Contracting Discussed

Weekly Highlights: February 27 - March 3

Part B Reforms: Competitive Bidding 2.0? MedPAC Moving “Drug Value Program” Proposal; Worth Watching Long Term

FDA User Fee Renewal Off To Smooth Start: First House Hearing On GDUFA Avoids Pricing Pitfalls; PDUFA Hearing Coming Soon

Buying Time For Biosimilars: BSUFA II Has Bipartisan Support, But Also Bipartisan Urgency To Start Delivering

FDA Advisory Committee Tracker: Where Are All The NDA Reviews? New OTC Topic May Be Heartburn For Alka-Seltzer

Democratic Rx Importation Bill Includes “Certified Foreign Seller” Designations; New Effort Behind Old Idea In Trump Era

PhRMA Also Going Collaboratively: Trade Group Finds Non-Pharma Voices To Support Pay Reform On Value-based Theme

Weekly Clips: February 21-24

FDA Patient Medical Information Reg May Be Delayed By Trump Transition; History Repeats Itself 35 Years Later?

FDA Ready To Operate New "On-Label" Rules: "CFL" Test Spelled Out By Agency; "Off-Label" Policy Awaits Political Direction

FDA User Fee Reauthorization Process Will Kick Off With Generic, Biosimilar Hearing March 2; Safe Start For Drug Pricing Tag-Along

National Academies’ Gene Editing Report Supports Strong FDA In Regen Medicine, Notes Useful Model From Gene Therapy

Weekly Highlights: February 13-17

CMS Nominee Verma “Thankful for the PBMs” In Part D, Views Medicaid Brand/Generic Classification for Rebates a “Priority”

Rx Spending Stands Out In CMS Projections – As Slowing Down; Timely Boost For Industry Message In Washington

Kite CAR-T Among Drugs Seeking FY18 Medicare Add-On Payments; Qualifying Products Need FDA Approval By July 1