• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trial Listings
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Clinical Trial Listings
  • Advertise
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Califf Sails Through Senate Confirmation Hearing

Califf Sails Through Senate Confirmation Hearing

December 20, 2021

President Biden’s pick to become FDA commissioner, Robert Califf, received bipartisan support last week during a two-hour Senate confirmation hearing that touched on innovation, real-world evidence (RWE) and the cost of clinical trials.

Califf, who was FDA commissioner from 2016 to 2017, hasn’t been shy to point out the alarming bulkiness clinical trials have packed on through the years as trial cost, duration and complexity continue to increase, leading to greater burdens and pitfalls for sites and calls for action to reverse those issues.

During the Senate Health, Education, Labor and Pensions Committee (HELP) hearing, Califf also faced questions on negotiated drug prices — which he supported, provided they do not “squelch” innovation — the agency’s perceived missteps in the opioid epidemic and what reforms he might make to the FDA’s accelerated approval pathway.

The Senate HELP committee has not set a date to vote on Califf’s nomination, a required step before the full chamber considers his nomination.

For RWE, Califf stressed the importance of developing a system that Americans trust to use their electronic health records (EHRs), calling a better evidence generation system essential to balancing innovation with patient safety.

Responding to questioning by Sen. Bill Cassidy (R-La.) about using RWE to arrive at quicker answers for drugs, especially those under the accelerated approval pathway, Califf said he believes that while the agency is “well down the road now in having a functional system … I also want to assure people I’m not talking about willy nilly analysis of data.”

Califf’s debut hearing as Biden’s nominee for commissioner appeared to go smoothly in the evenly divided Senate, though he was grilled harshly by both Sens. Maggie Hassan (D-N.H.) and Ben Ray Luján (D-N.M.) on the FDA’s role in the opioid crisis. Sen. Bernie Sanders (I-Vt.) also criticized Califf for his ties to the pharmaceutical industry.

While Hassan looks to be on the fence in voting for his nomination, Sens. Richard Blumenthal (D-Conn.), Joe Manchin (D-W.V.) and Ed Markey (D-Mass.) at the least will likely vote against him, and Califf is likely to need Republican support to get the job.

Adding to the chorus of support was a letter to the HELP committee sent last week by six former FDA commissioners — Andrew von Eschenbach, Scott Gottlieb, Stephen Hahn, Margaret Hamburg, Jane Henney and Mark McClellan — who said Califf “has the experience to be effective from Day One, having previously served as commissioner with strong bipartisan support.”

Read the letter from the former FDA commissioners here: https://bit.ly/3suFgFJ.

 

To view more CenterWatch Weekly stories, click here.

Upcoming Events

  • 25Apr

    Effective Root Cause Analysis and CAPA Investigations for Drugs, Devices and Clinical Trials

  • 26Apr

    FDA’s New Laws and Regulations: What Drug and Biologics Manufacturers Need to Know

  • 27Apr

    Califf’s FDA, 2023 and Beyond: Key Developments, Insights and Analysis

  • 17May

    2023 WCG Avoca Quality Consortium Summit

  • 21May

    WCG MAGI Clinical Research Conference – 2023 East

Featured Products

  • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

  • Surviving an FDA GCP Inspection

    Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

Featured Stories

  • Five Ws

    Consider the Five ‘W’s to Understand Potential Participants

  • QandA-360x240.png

    Perspectives from Smaller-Sized CROs: Q&A with Cheryle Evans

  • White House

    Trial Stakeholders Advise White House on Emergency Research Infrastructure

  • SurveywBlueBackground-360x240.png

    Stress Levels Continue to Climb in Healthcare Workforce, Survey Finds

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell or Share My Data

Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing