Congress Seeks Assurances 340B Program Benefits Vulnerable Patients

An explanatory report on the appropriations bill suggests that the pharmaceutical industry is succeeding in efforts to convince Congress that the 340B drug discount program should be doing more to ensure patients directly benefit from the discounts.

The just-passed 2015 federal appropriations bill includes a message from Congress that the agency overseeing the 340B drug discount program needs do more to ensure patients are directly benefiting from the program.

This message is included in an explanatory report on appropriations for HHS, which includes the Health Resources and Services Administration...

Welcome to Pink Sheet

Create an account to read this article

More from United States

Real-Time Release Of CRLs Is US FDA’s Goal, Agency Leaders Affirm

 

The US FDA says its release of complete response letters for products subsequently approved by the agency is just a first step toward releasing rejection letters when they are issued, assuming legal issues can be resolved.

No Surprise Here: Foreign Drug Facilities Should Expect Surprise Inspections, US FDA Says

 
• By 

The FDA's recent announcement of plans to expand unannounced inspections at ex-US facilities should put firms on advance notice that their next foreign facility inspection may not be preannounced, Ivy Sweeney, acting head of the agency's drug inspections office said.

Base Benefit-Risk Decisions On Data, Not Opinion And Passion, CDER’s Tidmarsh Says

 
• By 

New US FDA drugs center director George Tidmarsh’s data-centric comments at a Reagan-Udall Foundation meeting on unapproved fluoride products could suggest patients’ and caregivers’ experiences will carry less weight in benefit-risk decisions under his leadership.

Pink Sheet Podcast: FDA’s New Top Drug Regulator, Sarepta’s Options After Elevidys Stand-Off

Pink Sheet reporter and editors discuss the potential impact George Tidmarsh could have as director of the US FDA Center for Drug Evaluation and Research and the issues threatening the future of Sarepta’s gene therapy Elevidys.

More from North America

Merck’s Keytruda Gains Medicare Negotiation Reprieve With Expanded Orphan Exemption

 
• By 

Bristol Myers Squibb’s Opdivo and Merck's Welireg also could benefit from the delay in Medicare price negotiation process eligibility.

US FDA’s Biologics Center Departures Grew Before More Than 100 RIFs Exited

 

The Center for Biologics Evaluation and Research saw departures far outnumber new hires in the second and third quarters of FY 2025, before more than 100 people left July 14 after the reduction-in-force was finalized.

US FDA Cancer Reviewers Heading For The Exits, Potentially Impacting Review Timelines

 

US FDA's cancer drugs division is feeling the effect of drug reviewer departures, despite efforts to keep them at the agency.