FDA Climate Report As Gottlieb Era Begins: Approvals Up, As Is Rare Disease Flexibility; Complex Generics Complicate Outlook

House User-Fee Mark-Up: 180-Day Exclusivity for “Competitive Generics” Is Latest Attempt To Address Drug Prices In FDA Bill

OTC Regulatory Reform Unlikely To Join FDA User Fee Bill, But Bipartisan Effort Likely To Continue Post-FDARA

FDA Effort To Accelerate Generic Drug Alternatives In Tough-To-Copy Classes Faces Cautious Approach By New Drug Reviewers

ORA Program Alignment Impact: More Specialized Drug-Specific Teams, Faster Inspections

Weekly Highlights: May 8-12

Opioid Prescriber Training: FDA Meeting Underscores Challenges In Setting National Standards; CMS Policies Having Impact Now

Opioid REMS Updates Coming Soon: New CME Plan Emphasizes Pain Management, Not Product Info; IRs May Fold-In This Year

FDARA Heads to Senate Floor With Generic, Expanded Access Amendments; Drug Pricing Work Remains Outside User Fees

Autism PFDD Meeting Re-Frames Symptom Objectives; Patients Call For Focus On Communication Issues, Redefine “Irritability”

Perpetual FDA Reform? User Fees No Longer Only Vehicle For Changes: FDARA Moving Quickly, But More May Come After

FDARA Add-Ons: Small Changes In Big Areas; Tweaks To Opioid REMS, Orphan Drug Act, Importation And “Complex Generics”

Reagan-Udall Navigator Expanded Access Website Launching At Good Time: May Help Tone Down Interest In Right-To-Try

Senate HELP Clinical Trial Bill Offers Alternative To “Right-To-Try” Legislation; Not Yet Part Of User Fee Omnibus

FDA Plan For Cures Funding Emphasizes Combo Products, Regen Medicine Sections; OCE Not Separately Funded In 2017

Weekly Highlights: May 1-5

HHS’ Second Drug Price “Listening Session” Includes AARP –And Groups Advocating Co-Pay Reform

HHS Drug Pricing “Listening Sessions” Create Path For Options Report To White House

340B Reform Bill Coming Soon: House Sponsor Sees “Uphill Battle,” But Hearings Could Help Advance Pharma Goals

HHS Re-Org Is Opportunity to “Reimagine” and Reform, Secretary Price Tells Department Staff; Draft Proposal June 30

REMS/Restricted Distribution Reform Bill Reintroduced In Time For User Fees; CBO Scores Pro-Generic Bill At $3.3 Bil. Savings

Weekly Highlights: April 24-28

FDA Nominee Gottlieb Moves Forward With Some Democratic Support; Q&A Highlights Include Off-Label Policy, Public CRLs

“Right To Try” And PDUFA VI: Patient Advocates, Industry Fight To Stave Off – Or Revise – Senate Bill As Potential Amendment

FDA Advisory Committee Tracker: ODAC Is Back – And So Is Exondys; Biosimilar Neulasta May Be Running Out of Time