New Year’s Predictions From FDA Leadership Past And Present: GLP-1s, Mental Health, Big Data

Current and former commissioners note their positive expectations for the coming year and discuss efforts to standardize drug review and globalize filing of generics, while Janet Woodcock strikes a more sober tone on the ‘limitations of what both government and medicine can do.’

FDA chiefs
FDA Commissioner Robert Califf and fromer Commissioner Scott Gottlieb speak at CERSI Summit • Source: Screenshot from CERSI summit

US Food and Drug Administration Commissioner Robert Califf and three of his predecessors shared what they think will be positive developments in the new year, including continued health improvements from GLP-1 obesity treatments and a resurgence in drugs targeting mental health disorders.

Califf, former acting commissioner Janet Woodcock, and former commissioners Scott Gottlieb and Mark McClellan spoke on a panel at the Center of Excellence in Regulatory Science and Innovation (CERSI) summit on 7 January in San Francisco. Woodcock and McClellan appeared virtually

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

Legal, Process Problems May Plague New US FDA COVID-19 Vaccine Policy

 

The FDA may have violated laws and regulations along with many norms in how it released its planned changes for COVID-19 vaccine approvals.

US FDA COVID-19 Booster Strategy May Not Be As Controversial As It Seems

 

US FDA Commissioner Martin Makary’s call for placebo-controlled trials to confirm the efficacy of COVID-19 boosters is drawing a lot of criticism, but former Commissioner Robert Califf also supported the idea.

US FDA Legislative Lead Calls For User Fee Reforms As Renewal Talks Near

 

Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.

Califf In Conversation: ‘Decimated’ US FDA Teams Endanger Innovation

 

Pink Sheet sister publication In Vivo spoke to the former FDA commissioner about the recent layoffs and their impact on vaccine and other product development.

More from Agency Leadership

US FDA COVID-19 Booster Strategy May Not Be As Controversial As It Seems

 

US FDA Commissioner Martin Makary’s call for placebo-controlled trials to confirm the efficacy of COVID-19 boosters is drawing a lot of criticism, but former Commissioner Robert Califf also supported the idea.

US FDA Legislative Lead Calls For User Fee Reforms As Renewal Talks Near

 

Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.

Califf In Conversation: ‘Decimated’ US FDA Teams Endanger Innovation

 

Pink Sheet sister publication In Vivo spoke to the former FDA commissioner about the recent layoffs and their impact on vaccine and other product development.