Diabetes Outcomes Trial Requirement Looks “Increasingly Wise”— “Off-Topic” Discussion At FDA Endpoints Meeting

Weekly Highlights: August 22-26

OTC EpiPen Revived In Senate Letter To FDA Over Pricing: Is The Timing Right For A Forced Switch Petition?

FDA Continues Push To Improve ANDAs; Publishes Final Guidance On Refusing Applications That Lack Impurity Limit

Pfizer’s Troxyca Is First Opioid Approved After FDA Policy Change; Abuse-Deterrence Claims Differ from Committee Votes

Summer Is Over: Mylan’s EpiPen Pricing Catches Congress’ Eye; FDA Generic Process Likely In The Crosshairs Again

NIH Trials Reg Leads The Pack Of Prioritized Rules Likely To Be Finalized Before Obama Leaves; Almost 20 FDA Actions Pending

FDA Advisory Committee Trends: Panels Voted “Yes” 90 Percent of the Time in First Eight Months of 2016; 12 In A Row

Petitions Report To Congress Shows Sustained FDA Concern About Validity Of Attempts To Delay ANDAs, 505(b)(2) Applications

Weekly Highlights: August 15-19

FDA Reworks Co-Crystal Classification Through Guidance Revision In Response To Industry Concerns

CMS Coverage Decisions: NCD Topics List Stays Static For Now; OIG Report Addresses Disparate Data Sources for Local Coverage

PDUFA VI Meeting Underscores Smooth Process and General Content; Review Program, Patient-Input Headline Event

Weekly Highlights: August 8-12

CMS VBID Managed Care Model Expanded To Include Two New Clinical Categories, Close To Double The Target Beneficiaries In 2018

Ulcerative Colitis Guidance Calls for New Approaches To Assess Efficacy For Drug Approvals, Need For New COA and PRO Tools

Priority Review Vouchers: Considerations For A Deflating Market

CMS Add-On Payments: Defitelio, Praxbind, Vistogard Get NTAPs; CMS Considers Expanded Access Program in Decision-making

FDA “Disagrees” With OxyContin “Real World” Claim; Unusual Aside During Arymo Review May Portend Problems For Purdue

FDA Committee Supports Egalet Arymo Approval With Abuse Deterrence Claims; FDA Reset Of Panel Works – For Now

Weekly Highlights: August 1-5

CVS Health 2017 Formulary Excludes 35 Drugs; 8 Overlapping Express Scripts Exclusions

Lilly’s Taltz One of 85 Excluded From Express Scripts’ 2017 Formulary Showing Continuation of PBM’s Aggressive Approach

Egalet Arymo Likely To Garner ADF Claims For Inhalation, Injection; FDA Wants To Cut Off Broader Opioid Efficacy Debate

Medicare Part D: Drug Pricing Headlines But “Stable” Average Premiums; Will Catastrophic Coverage Become a Key 2017 Issue?