Drug Pricing “Shadow Mark-Up”: E&C Minority Amendment Includes New Formula For Manufacturer Discount In Part D, Sliding Scale For Spread In B

House Labor Committee Moves HR 3: Partisan Vote On Price Negotiation But Bipartisan Concern About Drug Prices

Prevision Policy Clips | Three Takeaways From Three HR3 House Events

House Republicans Seize On “Slower Cures” Argument Against HR 3: Exclusivity Reforms Are Better Option, GOP Witness Suggests

FDA Antimicrobial Drugs Committee Endorses Shionogi’s Cefiderocol For cUTI Despite Mortality Imbalance In Real-World Study; Panel Voices Concerns Over Broader Off-Label Use

Rx Price Negotiation Moving Rapidly Through House, Getting More Extreme As It Goes; Bipartisan Deal On Part D Reform Still Feasible

Prevision Policy Clips | CMS Administrator Verma Will Face First Democratic Oversight Hearing Oct. 23

FDA Leadership Feels Urgency To Challenge Critics On Perception Of “Lowered Bar” For New Drug Approvals

How to Do More With Labeling: Individualization Of Treatment, New Sources Of Evidence Pose Challenges For FDA’s Primary Communication Tool

Prevision Policy Clips | Price Negotiation Push In The House: Two Mark-Ups, One Hearing Set For Thursday

CBO “Price Negotiation” Score: $369 Billion Part D Hit To Industry Is Just The Beginning; Dangerous Theme Of How Much Innovation Is Worth Sacrificing

Real-World Trials May Qualify As “Adequate And Well-Controlled” – When Appropriate Controls Are In Place, FDA’s Stein Says At Duke Workshop

Prevision Policy Clips | HR3 Price “Negotiation” Provisions Would Save Nearly $350 Billion In Part D, CBO Says

Shionogi Cefiderocol: “Real World” Study Backfires, Making Complicated UTI Drug A More Complicated Review For FDA And Committee; Will LPAD Path Help?

FDA “Uni-Review” Roll-Out: Psychiatric Division Is Among “Early Adopters”; Collaboration Is Key Theme For New OND

FDA Office Of New Drugs Reorg Getting Warm Welcome From Division Directors, But Hiring Will Be Significant Pressure Point

White House War On Guidances Expands: FDA Is Not Main Target, But May Feel Some Collateral Damage

Prevision Policy Clips | House Price Negotiation Hearings Will Continue With Ways & Means Committee Oct. 17

Anti-Kickback Statute Remains Barrier To Rx Value-Based Agreements; New Rules Do Have Some Secondary Impacts

Prevision Policy Clips | FDA’s Role In “N of 1” Trials: Woodcock And Marks Editorial In New England Journal of Medicine

OCE Stands Alone: No Immediate Future For Integration Of FDA Medical Product Centers

Biopharma Congress Takeaways: FDA Reorg Appears Smooth, But Enough Is Enough

Prevision Policy Clips | HHS Anti-Kickback NPRMs Out; Future Rulemaking May Look At Safe Harbors For Pharma Value-Based Contracting

Novartis Remediation Plan For AveXis Shows Effort To Avoid Disruptive Integration In Quality Control Can Be Counterproductive

Prevision Policy Clips | FDA Draft Guidance On “Authorized” Imports Sent To OMB