1. Pink Sheet
  2. >>Agency Leadership
  3. >>US FDA

Time For Independent FDA? COVID-19 Political Pressure Reignites Debate

 
• By Kate Rawson

The political spotlight on the Food & Drug Administration during the COVID-19 pandemic has renewed the long-standing debate as to whether FDA should be made an independent, Cabinet-level federal agency and freed from direct HHS oversight.

FDABldg1ExteriorWithCircle_1200x675
Will there be renewed momentum to make the FDA independent of HHS as a result of the pandemic? • Source: File photo

The argument for an independent FDA has taken on renewed interest as President Trump has applied political pressure on the agency (via Twitter and elsewhere), most notably to claim a vaccine approval before Election Day. FDA’s ability to remain independent was a topic of discussion of a panel of five former chief counsels and current Office of Chief Counsel Chief Deputy Elizabeth Dickinson during the Food & Drug Law Institute’s annual meeting 7 October.

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
Start Free Trial

Already a subscriber?

More from US FDA

US FDA’s Makary Floats Vague ‘Plausible Mechanism’ Approval Pathway For Rare Diseases

 
• By Sarah Karlin-Smith

Ascertaining the novelty and benefits of Makary’s new drug approval idea – along with what it would take to implement it – requires more clarity on the types of studies he envisions being used to grant and confirm “plausible mechanism’ approvals.

US FDA Commissioner Makary Wants To Combine Adverse Event Reporting Systems

 
• By Sarah Karlin-Smith

In discussing FDA’s adverse event monitoring, Makary also seemed to falsely imply the agency did not fully investigate the myocarditis signal with COVID-19 vaccines.

US FDA User Fee Collection Safe In Preliminary Trump 2026 Budget Plan

 
• By Cathy Kelly

The preliminary White House 2026 budget plan cuts agency funding, but not so sharply that user fees are excluded from collection.

FDA Special Assistant Høeg’s Vaccine Concerns On Display At ACIP

 
• By Sue Sutter

Tracy Beth Høeg, who is reportedly re-examining Novavax’s COVID vaccine application, is the FDA rep at the CDC panel’s first meeting under the Trump Administration. She raised concerns about routine use of Jynneos for adolescents at risk of mpox and questioned how Moderna assessed efficacy of its COVID vaccines.

More from Agency Leadership

FDA Reorganization Proposal A ‘Mindless Approach To Centralization,’ Woodcock Says

 
• By Sue Sutter

Plan to reorganize the agency into five offices was designed by someone who does not understand the FDA, former long-time agency official Janet Woodcock says. The proposal would eliminate highly specialized expertise in favor of “a big team of generalists,” former Principal Deputy Commissioner Joshua Sharfstein says.

US FDA Staff’s Union President Calls For More Support From Industry

 
• By Sarah Karlin-Smith

Industry should be more vocal about the harms the recent reduction-in-force will have on getting drugs to market, NTEU Chapter 282 President Anthony Lee said in an interview with Pink Sheet.

HHS’ Kennedy Warns US FDA Staff Against ‘Agency Capture’ By Industry, Special Interests

 
• By Sue Sutter

HHS Secretary Robert F. Kennedy Jr. urged FDA staff to resist the “deep state” and “crony capitalism,” and focus on improving the health of America’s children. “You're not here to take orders,” he said and urged FDA staff to speak up if they see wrongdoing.