340B Reform Legislation Will Wait Until 2017 Or Beyond; DSH Metric For Eligibility Is Focus of Divide-and-Conquer Strategy

Part B Demo Hearing Serves As Proxy Battle Over Drug Prices; Risk To Industry Emerges In ASP?

Reagan-Udall Expanded Access “Navigator” Would Create “One-Stop Shop,” Facilitate Patient Contact To Sponsors, FDA

Electronic Health Record Guidance For Clinical Trial Data From FDA States Potential Benefits, Urges Interoperability

The Opioid REMS And Pharma’s Reputation: Slow Uptake May Become Significant Vulnerability As Pricing Debate Continues

House Opioid Bills Leave Buprenorphine Cap To Administrative Reform; No Mandatory Prescriber Education

Weekly Highlights: May 9-13

Aegerion Juxtapid Settlement Shows REMS Have Teeth: Alternate Route To Enforce Off-Label?

New Scheduling Schedule: DEA Meets 90-Day Deadline For Listing UCB’s Briviact; Focus May Shift To FDA Timelines Next

REMS “Platform” Workshop Set for June; Negative Feedback On TIRF REMS Suggests Model May Need More Work

Making Opioid Education Mandatory: DEA Registration Is “Easiest” Approach, FDA’s Advisors Say – But FDA Can’t Do It

SPA Draft Guidance Gets Major 14-Year Revision: Outlines Rescinding Process, Biosimilars and Animal Rule Drugs Added

Weekly Highlights: May 2-6

KemPharm Apadaz Headed To Market Without Abuse Deterrent Claim After Committee Vote

Opioid REMS Review: IR Likely To Join REMS Soon, But Mandatory Training Farther Off: CDC Guidelines New Template?

CMS Feeling The Pressure On Part B Demo; Agency Says It Could Limit Scope, Delay Start Of Alternative To ASP+6%

FDA Hep C Guidance: Head-to-Head Comparisons Necessary For Trials Of New Agents After Wave Of Approvals

Insurance Restructuring or Copay Caps? BioPharma Has Nuanced Message to Push Against Simple-Sounding Solution

KemPharm Apadaz: FDA Suggests Approval Of First Abuse-Deterrent IR Opioid Is Likely, But Initial Claim Will Be Limited

FDA Advisory Committee Tracker: Merck C. Diff Antibody Heads To Panel In June; Still No Biosimilar Panels On Calendar

Weekly Highlights: April 25-29

Opioid REMS Advisory Committee: No Up-or-Down Vote on Adding IR Products Planned, Per FDA Draft Questions

MEDCAC Defines Treatment-Resistant Depression: Failure of Two Drug Therapies Is Acceptable Definition for Medicare

Valeant Pricing Hearing Comes Full Circle: FDA Generic Drug Reforms Are Immediate Action Item; Does It End There?

Abuse-Deterrent Formulations Protected From Medicaid Line-Extension Rebate As Part Of House Opioid Abuse Legislation