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

 
• By Derrick Gingery

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...

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More from US FDA

Pink Sheet Podcast: CBER Director’s Political Spin On COVID-19 Vaccines And US FDA RIFs Finalized

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors discuss CBER Director Vinay Prasad using an unproven theory to help explain his COVID-19 vaccine decisions and the impact of the recently finalized reduction-in-force at the FDA.

Prasad Cites Unproven Theory Defending His COVID-19 Vaccine Decisions

 
• By Sarah Karlin-Smith

In defending his decision to overrule agency staff on three recent COVID-19 vaccine applications, the CBER director questioned the original timing of Pfizer’s COVID-19 vaccine authorization, reviving a long-held, but unproven grievance of President Trump.

Access Risks Loom For All Drugmakers With Fourth Circuit Mifepristone Decision

 
• By Sarah Karlin-Smith

The FDA law establishing REMS authority does not preempt a West Virginia law that would restrict mifepristone use in the state, an appeals court said, a decision that could have broader ramifications for the agency’s authority to ensure drug access.

US FDA’s Drugs Center Lost Hundreds Of Staff Through June With 600 RIFs Coming

 
• By Derrick Gingery, Sue Sutter, and Sarah Karlin-Smith

The official separation of those impacted by the reduction-in-force and some others who are leaving the agency are not yet reflected in CDER employee gains and losses data.

More from Agency Leadership

Access Risks Loom For All Drugmakers With Fourth Circuit Mifepristone Decision

 
• By Sarah Karlin-Smith

The FDA law establishing REMS authority does not preempt a West Virginia law that would restrict mifepristone use in the state, an appeals court said, a decision that could have broader ramifications for the agency’s authority to ensure drug access.

US FDA’s Drugs Center Lost Hundreds Of Staff Through June With 600 RIFs Coming

 
• By Derrick Gingery, Sue Sutter, and Sarah Karlin-Smith

The official separation of those impacted by the reduction-in-force and some others who are leaving the agency are not yet reflected in CDER employee gains and losses data.

Consumer Groups Have A ‘Radical Transparency’ List For US FDA’s PDUFA VIII

 
• By Sarah Karlin-Smith

Development of the user fee commitment letter largely takes place behind closed doors between industry and FDA. Outside groups see the upcoming negotiation cycle as a chance to change this and other agency information blocks by reminding Commissioner Makary of his commitment to transparency.