Hahn Defends Using Less ‘Robust’ Data During COVID, But Critics Contend It Has Gone Too Far

US FDA Commissioner Hahn says agency's choice to make fast decisions on less robust data sets during COVID-19, paired with constantly reevaluating these decisions drives best public health outcomes. But critics argue the agency may be pushing the bar too low and needs to be more transparent about the evidence it is using for emergency use authorizations.

Stephen Hahn of MD Anderson Cancer Center is expected to be nominated for FDA commissioner
FDA Commissioner Stephen Hahn gave an update on the agency's COVID-19 efforts this week

The US Food and Drug Administration Commissioner Stephen Hahn defended the agency’s decision making during the COVID-19 pandemic as being rooted in “good data and sound science,” while acknowledging that it has made risk-benefit decisions on medical products using “data sets that might not be as robust as they would under normal circumstances.”

In a speech given over teleconference to the Alliance For A Stronger FDA on Monday, Hahn also said that FDA...

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

US FDA Commissioner Makary Is Learning To Appreciate His Staff

 

After three months on the job, FDA Commissioner Martin Makary is sounding much more effusive about the quality of the agency staff. Better late than never?

Complete Response Letter Trio Raises Prospect Of Tidal Shift In Regenerative Medicine Regulation

 

Replimune's RP1 oncolytic immunotherapy became the third regenerative medicine to receive an FDA complete response letter this month as the agency appears to re-visit previous agreements about accelerated approval.

Business Background Of New CDER Director George Tidmarsh

 

George Tidmarsh has extensive experience in the biopharmaceutical industry and led several drugs to FDA approval.

US FDA Could Seek Stronger Warnings On SSRI Antidepressant Risks During Pregnancy

 
• By 

Testimony during a July 21 ‘expert panel’ could help justify stronger warnings across the class about potential adverse effects on mother and baby. Panelists ranged from clinicians who said depression during pregnancy should be treated, to those who said sadness has been “medicalized."

More from Agency Leadership