The heart doctor who is waiting for the U.S. Senate to confirm his appointment as Commissioner of the U.S.Food and Drug Administration has been keeping the schedule of a famous cardiologist. Dr. Robert M. Califf’s meetings with “persons outside the executive branch of the federal government” have been publicly disclosed by FDA ever since he joined the agency last March as deputy commissioner for medical products and tobacco. Those reports continued after President Obama appointed the former Duke University cardiologist as the next FDA Commissioner, subject to Senate confirmation. A review of his public calendar by Food Safety News finds Dr. Califf has attended about 60 events outside the office during his first ten months at FDA.  Among the things that stand out:

  • It appears he is not giving up his white coat, as at least twice he’s gone on “Grand Rounds” at famous Boston hospitals, Massachusetts General and Brigham and Women’s.
  • Dr. Robert M. Califf
    Dr. Robert M. Califf
    He must own more than one tux, because sometimes he’s got those gala fund raising events scheduled back-to-back, especially if they support heart, cancer, kidney or other life science research.
  • Except for meeting with Democratic Sen. Patty Murray’s staff on “Vitro Diagnostics” before his nomination as commissioner, his public calendar at FDA does not show him meeting with any U.S. Senators to lobby for his confirmation.
  • Except for trips to California, Colorado and London, the great bulk of the seminars and scientific meetings Califf has attended were in the Washington D.C. to New York City corridor.

There is nothing in his schedule to indicate Califf has even a casual interest in food safety, but it is also not part of his current duties as deputy commissioner. Califf is a nationally and internationally recognized expert in cardiovascular medicine, health outcomes research, healthcare quality, and clinical research. He is known for leading many landmark clinical trials and is one of the most frequently cited authors in biomedical science, with more than 1,200 publications in the peer-reviewed literature. His nomination by President Obama as the next FDA Commissioner was approved earlier this week by a Senate committee, but a floor vote has not yet been scheduled.  Califf’s Senate confirmation hearing was in November. It was not listed on his public calendar. His public calendars through Dec. 5 are available here.  For many events they include lists of individuals who attended with Califf, including other FDA personnel and people outside the executive branch of government of the federal government. Here’s what Califf has been up to since joining FDA: March

  • Society for Women’s Health Research, 25th Anniversary Gala Dinner,  Washington D.C.
  • National Institutes of Health (NIH) Advisory Committee to the Director: Precision Medicine Initiative Working Group, Silver Spring, Md.

April

  • Institute of Medicine Consensus Committee on Policy Issues in the Clinical Development and Use of Biomarkers for Molecularly Targeted Therapies, Washington D.C.
  • FDA and Indian Pharmaceutical Alliance Meeting, Silver Spring, Md.
  • University of Pennsylvania, 8th Annual Conference on Statistical Issues in Clinical Trials, Philadelphia.
  • Clinical Research Forum Annual Meeting/Translational Science 2015 Annual Meeting (Association for Clinical and Translational Science and American Federation for Medical Research): Joint Opening Plenary Session, Washington D.C.
  • Drug Information Association/FDA Statistics Forum 2015, Washington D.C.
  • American Physician Scientists Association Policy Panel: Policies Governing Bench to Bedside, Entrepreneurship in Biomedical Research, Chicago
  • American Heart Association Data Summit: Acquisition, Analysis and Sharing of Data in 2015 and Beyond A Survey of the Landscape, Baltimore
  • NIH Advisory Committee to the Director: Precision Medicine Initiative Working Group Meeting: Unique Scientific Opportunities for the Precision Medicine Initiative National Research Cohort, Bethesda, Md.
  • Medical Device Innovation Consortium Clinical Trial Innovation and Reform 2015 Workshop, Bethesda, Md.
  • Washington Clinical Pathological Society 150th Anniversary Banquet, Chevy Chase, Md.

May

  • Massachusetts General Hospital Cardiology Grand Rounds, Boston
  • Brigham and Women’s Hospital Cardiovascular Grand Rounds, Boston
  • Tufts Center for the Study of Drug Development: Re-engineering Clinical Trials, Washington D.C.
  • National Library of Medicine Board of Regents Dinner, Chevy Chase, Md.
  • Medical Device Innovation Consortium Patient Centered Benefit-Risk Project: Introducing the Framework for Integrating Patient Perspective into Medical Device Benefit-Risk Assessments, Washington D.C.
  • Friends of Cancer Research Roundtable: Enhancing Patient Input and Regulatory Innovation, Washington D.C.
  • 3rd Annual Kidney Health Initiative Stakeholder Meeting, Bethesda, Md.
  • Stanford University: Big Data in Biomedicine Conference, Stanford, Calif.

June

  • Recorded Lecture for Georgetown University Center of Excellence in Regulatory Science and Innovation Program: Introduction to Regulatory Science, Silver Springs, Md.
  • Institute of Medicine: Forum on Neuroscience and Nervous System Disorders, Washington D.C.
  • Laboratory Derived Tests, Silver Springs, Md.
  • Ohio State University College of Medicine Department of Biomedical Informatics Clinical Research Recruitment Workshop, Columbus, Ohio
  • International Coalition of Medicines Regulatory Authorities (ICMRA), Washington D.C.
  • DIA 2015 51st Annual Meeting, Washington D.C.
  • FDA-European Medicines Agency (EMA) / European Commission (EC) Bilateral, Silver Spring, Md.

July

  • Precision Medicine Initiative Working Group of the Advisory Committee to the NIH Director: Participant Engagement and Health Equity, Bethesda, Md.
  • Laboratory Derived Tests, Silver Spring, Md. ( With Dave King, CEO of LabCorp, American Clinical Laboratory Association)
  • Laboratory Derived Tests, Silver Spring, Md. (second day, Anna Cook and Christopher Newton Cheh, Massachusetts General Hospital)
  • Juvenile Diabetes Research Foundation Children’s Congress Meeting, Silver Spring, Md.
  • 30th Annual National MD/PhD Student Conference, Keystone, Colo.
  • NIH Advisory Committee to the Director: Precision Medicine Intiative Working Group Meeting: Mobile and Personal Technologies in Precision Medicine, Santa Clara, Calif.
  • Center for Health Policy at Bookings: Improving Productivity in Pharmaceutical Research and Development: The Role of Clinical Pharmacology and Experimental Medicine, Washington D.C.
  • Health Care Economic Information, Silver Spring, Md.
  • Meeting with FDA on J&J Proposal on Combination Products, Silver Spring, Md.

August

  • Briefing with staff of Sen. Murray, D-WA, on In Vitro Diagnostics, Washington D.C.
  • Site Visit at Vanderbilt University, Nashville
  • Million Hearts Leadership Roundtable, Washington D.C.
  • 2015 European Society of Cardiology Congress, London

September

  • 2015 ASA Biopharmaceutical Section FDA-Industry Workshop – Role of Statisticians, Washington D.C.
  • Multiple Myeloma Research Foundation (MMRF) Leadership Circle Summit, New York City
  • Heart Failure Society of America: 19th Annual Scientific Meeting: The Economic Model of Heart Failure Care, Oxon Hill, Md.

October

  • Strategic Goals of the European Medicines Agency and U.S. FDA, London
  • European Society of Cardiology Cardiovascular Round Table Plenary Meeting “Improving Public Health by Improving Clinical Trials,” London
  • Institute for Translational Medicine and Therapeutics 10th Annual International Symposium: Role of FDA in Stimulating Translational Science, Philadelphia
  • American Heart Association Thought Leader Summit for Precision Cardiovascular Medicine: FDA Efforts Relevant to Cardiovascular Precision Medicine, Washington D.C.
  • National Coalition for Cancer Survivorship Honors, Focus on the Care Reception, Washington D.C.

November

  • Faster Cures – 7th Annual Partnering for Cures Meeting – On the Horizon: R&D Renaissance or ReBoot? New York City.
  • Meeting with Georgetown University students regarding lecture for PHAR620 Intro to Regulatory Science, Washington D.C.
  • The Association of Professors of Cardiology Fall Meeting (APC), Orlando, Fla.
  • American Heart Association Scientific Sessions 2015: Connected Health Care: Clinical Technical, and Regulatory Challenges: The FDA’s Perspective on Regulating Innovations in Health Technology, Orlando, Fla.
  • 2015 Friends-Brookings Conference on Clinical Cancer Research, Washington D.C.
  • Meta-Research Innovation Conference: Improving Biomedical Research 2015: Challenges and Solutions, Sanford, Calif.
  • Life Sciences Consortium Symposium – Food and Drug Administration, Bethesda, Md.

December

  • The Moon Shot: A National Immunotherapy Initiative for Cancer, Washington D.C.
  • FDA/JHU CERSI Workshop, Silver Spring, Md.
  • How to Become a Cardiovascular Investigator, Washington D.C.
  • 12th Global CardioVascular Clinical Trials Forum, Washington D.C.

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