Weekly Highlights: December 18-23

National Academies’ Drug Affordability Project Plumbs Price “Opacity”; Hears Different Positions On Degree of Transparency

Senate Aging Committee Closes Books On Pricing Investigation; Co-Pay Coupons Need “Further Study” – Not Immediate Action

Opioid REMS Will Add IR Products, FDA Says: Process To Kick Off In January; Kick-Start Mandatory Training As Alternative?

Vaccines In “Cures”: Deadline For ACIP Recommendations Are Gone, But “Timely Review” And “Flexibility” Are Still Key

The ABC’s of Special Status (Update): 21st Century Cures Act Adds Three New Items To Menu Of Special FDA Designations

Weekly Highlights: December 12 - December 16

Rx Legislation In 2017: Hill Staff Expect Drug Pricing May Be Issue For PDUFA VI; CMMI Not Dead Yet – Even If Part B Demo Is

Dose of Reality For Hyper-Fast Oncology Development: National Cancer Policy Forum Pushes Back On “Seamless” Model

Patient Advocacy Groups Push Back Against First Signs Of Trump Administration Effort To Cut Efficacy Standard

Expanded Access Provision In “Cures” Act Takes Effect Soon; Manufacturers Are Required To Set Policy For Patient Requests

FDA “Program” Final Report Aligns With Positive PDUFA VI Feedback, But Manufacturing Inspections Remain A “Black Box”

HHS Transition: Trump Team Has Ties To George W. Bush Administration; Former FDA Deputy Gottlieb May Run Agency

Limited Population Antibacterial Pathway Finally Becomes Law; Potential For Expansion to Other Classes – Eventually

Part D Rebates Would Save $145 Billion, CBO Says In Latest Budget Options Paper; Small Compared To ACA Repeal Savings

Weekly Highlights: December 5 - December 9

Biosimilars Pathway Likely to Survive ACA Repeal/Replace – But Tweaks Possible In Context Of 2017 User Fee Bill

FDA Commissioner O’Neill? Name Floated, But Resumé Is Atypical; HHS Experience Suggests Some Trump Position Likely

The “Cures” Dissenters: The Coming Fight Over Promotional Policy – And Setting Tripwires Over FDA Decisions In The Future

FDA Reforms In Final “Cures” Bill Largely Track With PDUFA VI; “Platform Approvals” In, Accelerated Approval Provisions Out

“Low-T” To PRO-T: Trials For Alternatives To Testosterone Need Patient-Reported Outcome Measures Or Other Clinical Endpoints

FDA’s Jenkins To Retire As Top Drug Review Manager, Breaking Up Team Of Experienced Center Leaders; Will Others Follow?

Weekly Highlights: November 28 - December 2

PBMs, PCSK-9s, And The Next Pricing Debate: Do New Indications Justify Higher Prices – Or Lower Ones?

Advisory Committee Tracker: The Lull Continues – No More Drug Reviews On The Calendar Through End Of 2016