1. Pink Sheet
  2. >>Pink Sheet Perspectives

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

 
• By Sarah Karlin-Smith

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
Key Takeaways
  • Outgoing commissioner Robert Califf is credited with strengthening the FDA internally and externally, but experts are unsure if the agency can maintain the gains under the Trump Administration.
  • Califf was willing to solve problems rather than paper over them and received strong reviews for his reorganization of the FDA's food and inspection programs.
  • He was cautiously optimistic that the realities of governing will temper the plans of some of President Trump's likely health leaders.

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...

The American people’s confidence in the FDA would quickly be tested again under Califf. The agency grappled with infant formula contamination that resulted in the death of two children and...

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 Pink Sheet Perspectives

Precision Underlines US FDA’s 2025 Cancer, Neuroscience Candidates

 
• By Bridget Silverman

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

 
• By Bridget Silverman, Nancy Pham, and Kosh Naran

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

 
• By Francesca Bruce

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

 
• By Bridget Silverman

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.

More from Geography

ClinicalTrials.gov Or ISRCTN: Getting Transparency Right For UK Trials

 
• By Vibha Sharma

ISRCTN’s systems are being redesigned to facilitate compliance with upcoming requirements in the UK’s clinical trials legislation.

Darzalex Faspro Gains US FDA AdComm Support For Smoldering Myeloma Claim

 
• By Bridget Silverman

The use of J&J’s Darzalex Faspro in high-risk smoldering multiple myeloma could result in overtreatment, but the FDA committee voted in favor of the new claim for delay in development of multiple myeloma.

STARGLO Dulled: Genentech’s Columvi Data Not Generalizable To US Patients, FDA Panel Says

 
• By Sue Sutter

The glofitamab trial results are not generalizable due to the small number of enrolled US lymphoma patients and adverse results across multiple endpoints for patients from non-Asian regions, the Oncologic Drugs Advisory Committee said.