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Gottlieb: FDA Would Be Subject To More White House Control Under A Second Trump Term

 
• By Sarah Karlin-Smith

The former commissioner warned that the FDA likely would get very different treatment under a second Trump term than it got under a first. Gottlieb also discussed the need for legislation to help advance ‘n of 1’ drug regulation and how to communicate uncertainty in a wide-ranging interview.

Former FDA Commissioner Scott Gottlieb is interviewed at a 1 February Friends of Cancer Research Event
Former FDA Commissioner Scott Gottlieb was interviewed 1 February at a Friends of Cancer Research diagnostic policy event. • Source: Friends of Cancer Research/YouTube

The US Food and Drug Administration under a “Trump 2.0” is unlikely to be given the same independence from White House oversight that it enjoyed during Donald Trump’s initial term as president, said Scott Gottlieb, Trump’s first FDA commissioner.

“There was a little less adult supervision,” Gottlieb said of the Trump administration’s oversight of

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Global Pandemic Deal Adopted As 124 Countries Say Yes; US Sits Out

 
• By Neena Brizmohun

Now that the landmark Pandemic Agreement has finally been adopted, work will start on drafting a pathogen access and benefit sharing system that will be voluntary for use by drug companies.

Observational, Retrospective Trials Could Retest Vaccines, HHS’ Kennedy Says

 
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The Health and Human Services secretary told a Senate appropriations subcommittee that placebo-controlled trials may not be necessary to ensure vaccine safety as the FDA released a framework requiring them for COVID-19 vaccines.

EU Shaping Biotech Act To Unleash SME Potential

 
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EU Council Could Adopt Pharma Reform Package Next Week, But Disputes Risk A Year’s Delay

 
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The Council of the EU wants to adopt its negotiating position on the reform of the general pharmaceutical legislation “sooner, rather than later,” but divergence between member states could push negotiations back another year, a European Commission policy officer said today.

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

 
• By Sarah Karlin-Smith

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

Observational, Retrospective Trials Could Retest Vaccines, HHS’ Kennedy Says

 
• By Derrick Gingery

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HHS Negotiating With Manufacturers On Most Favored Nation Drug Pricing

 
• By Cathy Kelly

MFN policy would would apply to all single source drugs in all insurance markets, according to HHS release. Secretary Robert F. Kennedy Jr. said the department is discussing the plan with drug sponsors.