Gottlieb Places Drug Pricing Out Front In First Speech To US FDA Staff

New FDA Commissioner tells employees that 'too many consumers are priced out of medicines they need' and that FDA must take meaningful steps to get lower cost alternatives to market.

Scott Gottlieb, new FDA commissioner, speaks to staff
New FDA Commissioner Scott Gottlieb speaks with agency staff following his first speech to them since taking office. • Source: FDA

Scott Gottlieb appears poised to pull drug pricing out of the shadows and make it a more visible action item for the US FDA, despite the agency's awkward position in the debate.

In his inaugural remarks to FDA staff, the new commissioner identified rising drug costs among the pending challenges for the...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from US FDA

Precigen’s Papzimeous Approval Allows US FDA CBER Director To Emphasize Flexibility

 

Returning FDA biologics center director Vinay Prasad used the Papzimeous approval announcement to reinforce his flexibility on rare disease therapies after several complete response letters and his brief departure from the agency.

A US FDA Move to Revoke Pfizer’s Pediatric COVID-19 Vaccine EUA Could Raise Supply Questions

 

Pfizer still has not submitted a supplemental biologics license application for the youngest population even though people familiar say it has dominated that market. Moderna says it can “step up” supply.

Prasad’s Return Shelves Center Consolidation, But Maybe An Opening For OCE 2.0?

 
• By 

Vinay Prasad’s exit from the US FDA reignited conversations about integrating its drugs and biologics centers under George Tidmarsh. Those plans appear to be shelved, but the leadership transition could be an opportunity to fully realize the vision for the Oncology Center of Excellence.

Prasad 2.0 Brings New Instability Concerns, Questions About Changed Regulatory Philosophy

 

Many agency stakeholders believe Vinay Prasad may be forced to change his regulatory approach at least somewhat after receiving a second chance to lead the US FDA's biologics center.

More from Agency Leadership