Robert Califf Stabilized US FDA, His Departure May Signal A Coming Storm

The two-time FDA commissioner resigned on 20 January as part of the administration change. Califf is credited with righting an agency demoralized from the COVID-19 pandemic, but worries about its future are high.

Robert Califf at CERSI
Two-time FDA Commissioner Robert Califf received high marks, but agency stakeholders worry about what is next. • Source: Screenshot

When Robert Califf returned to White Oak as US Food and Drug Commissioner for the second time in February 2022, the highly lethal wave of the COVID-19 omicron variant was raging and much of the agency was downtrodden after more than two years of nonstop pandemic work and public backlash from controversial decisions and political meddling by the first Trump Administration.

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Precision Underlines US FDA’s 2025 Cancer, Neuroscience Candidates

 

Top areas for potential 2025 approvals were shaped by R&D focused on increasingly tightly targeted therapies, including the eight new candidates to join the still-burgeoning kinase inhibitor class and RNA interference, as well as many varieties of antibodies.

Novel Agents Up For US FDA Approval In 2025

 

CBER has at least 14 and CDER another 10 novel biologics among the more than 60 candidates with a user fee goal in 2025.

Balancing Competitiveness and Sustainability In EU Regulations, What’s Next For Pharma

 

Restrictions on commonly used chemicals, increased reporting requirements and enhanced environmental risk assessments are just some of the new EU sustainability and environmental rules pharmaceutical companies are potentially facing. While some measures are multi-sectoral, others are pharma specific. The Pink Sheet takes a look at some of the developments in 2024 and expectations for 2025 and beyond.

More Heart, Less Skin: US FDA’s 2025 Novel Approvals Should Reflect Pipeline Shifts

 

Only one-third of novel agents with 2025 goal dates come from the traditional oncology, hematology and neuroscience strongholds. Immunodermatology also is cooling, while cardiovascular drugs return to the front burner.

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Are Bigger Ad Policy Changes Coming After US FDA’s Drug Promotion Office Hit Hard By Layoffs?

 
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The loss of policy analyst, legal, project manager and social scientist positions has experts wondering if the Trump Administration is eyeing a broader effort to limit DTC advertising. The OPDP layoffs are expected to result in delayed reviews of promotional pieces.

Landmark Pilot Paves Way for Faster Drug Approvals In Africa

 

In a historic move for Africa, five products have been backed for approval via a pilot that tested a continental listing process.

Brazilian Drug Price Increase Rates Hit Eight-Year Low

 

CMED, which sets medicine prices in Brazil, has published the maximum price adjustment index for 2025.