Robert Califf
25th Commissioner of Food and Drugs
Assumed office
February 17, 2022
PresidentJoe Biden
DeputyJanet Woodcock
Preceded byJanet Woodcock (Acting)
In office
February 22, 2016 – January 20, 2017
PresidentBarack Obama
Preceded byMargaret Hamburg
Succeeded byScott Gottlieb
Personal details
Born1951 (age 72–73)
Anderson, South Carolina, U.S.
Political partyDemocratic
EducationDuke University (BS, MD)

Robert McKinnon Califf (born 1951) is an American cardiologist who currently serves as the 25th Commissioner of the Food and Drug Administration.

He was first nominated to be commissioner in September 2015 by President Barack Obama[1] and he was confirmed by the U.S. Senate in February 2016,[2] serving until January 20, 2017.

President Joe Biden renominated Califf to head the Food and Drug Administration on November 12, 2021.[3] He was confirmed by the Senate on February 15, 2022.

Prior to becoming commissioner he had served as the Deputy Commissioner of the United States Food and Drug Administration's Office of Medical Products and Tobacco since January 2015.[4][5][6] In 2019, he became head of medical strategy at Google parent company Alphabet Inc.[7]

Early life and education

Califf was born in Anderson, South Carolina.[8] He attended high school in Columbia, South Carolina where he was a member of the 1969 AAAA South Carolina Championship basketball team.[9] He attended Duke University, graduating in 1973 summa cum laude[4] and is a member of Phi Beta Kappa.[9]

In 1978, he graduated from the Duke University School of Medicine in Durham, North Carolina,[4] and was inducted into the Alpha Omega Alpha medical honor society.[9] He left North Carolina for an internal medicine residency at the University of California, San Francisco and returned in 1980 to Duke to complete a fellowship in cardiology.[4] He is board-certified in internal medicine (1984) and cardiology (1986), and a Master of the American College of Cardiology (2006).[9]

Career

Duke University

Califf was granted tenure as professor of cardiology at Duke University School of Medicine. He was the founding director of the Duke Clinical Research Institute, which is considered "the world’s largest academic research organization" with 1000 employees[4] and an annual budget of $320 million, 50-60% of which is funded from the pharmaceutical industry.[10]

Google

Califf led strategy and policy for Alphabet’s health subsidiaries. He was the full-time head of strategy and policy for its Verily Life Sciences and Google Health divisions.[11]

Califf has led many clinical cardiology research studies, health outcomes research, health care quality, and translational research, which seeks to ensure that advances in science translate into medical care. He was a lead investigator in clinical trials testing the efficacy of the cholesterol-lowering drug combination ezetimibe/simvastatin.[12]

As of 2015, he was vice-chancellor of clinical and translational research and the Duke Translational Medicine Institute (DTMI) director. Califf is recognized by the Institute for Scientific Information as one of the top 10 most cited medical authors, with more than 1,200 peer-reviewed publications.[5]

Relationships with the pharmaceutical industry

Califf worked very closely with pharmaceutical companies at the Duke clinical trials center "convincing them to do large, expensive, and, for Duke, profitable clinical trials."[13] He was a paid consultant for Merck Sharp & Dohme, Johnson & Johnson, GlaxoSmithKline, AstraZeneca, and Eli Lilly per ProPublica from 2009 to 2013. The largest consulting payment was $87,500 by Johnson & Johnson in 2012, and "most of funds for travel or consulting under $5,000", which has been called "minimal for a physician of his stature".[14] From 2013-2014 he was paid a total of $52,796; the greatest amount being $6,450 from Merck Sharp & Dohme, followed by Amgen, F. Hoffmann-La Roche AG, Janssen Pharmaceutica, Daiichi Sankyo, Sanofi-Aventis, Bristol-Myers Squibb and AstraZeneca.[15] He was a director of Portola Pharmaceuticals, Inc. from July 2012 to January 26, 2015,[14] an advisor for Proventys, Inc., chairman of the medical advisory board of Regado Biosciences, Inc. and has been a member of that board since June 2, 2009, and a member of the clinical advisory board of Corgentech Inc.[16] Forbes wrote that his close ties to the drug industry were why he was not nominated for the FDA Commissioner position in 2009.[13] Califf's ties to the pharmaceutical industry were criticized by the magazine The American Prospect,[17] and Democratic Senators Bernie Sanders and Joe Manchin, who announced their intention to vote against his 2021 renomination.[18]

FDA under Obama

In January 2015, Califf was appointed Deputy Commissioner of the United States Food and Drug Administration's Office of Medical Products and Tobacco, "second in scope only to being commissioner".[4][6] In February 2015, Califf was cited as a possible successor to Margaret Hamburg, the outgoing Commissioner of the Food and Drug Administration.[19] and in September 2015, President Barack Obama nominated him to be the next FDA commissioner.[1] In February 2016, the US Senate confirmed Califf as commissioner of the Food and Drug Administration by a vote of 89-4.[20] [2] Califf stepped down from the post of FDA commissioner on January 20, 2017.

FDA under Biden

On November 12, 2021, President Biden announced he was nominating Califf to return as head of the FDA.[21][22] During his hearing before the Senate HELP committee on December 14, 2021, he was questioned relating to the pandemic, opioid crisis, and issues relating to abortion. Some Democrats opposed his nomination due to his corporate ties and the opioid crisis. Several Republican senators opposed his nomination because of issues relating to abortion.[23]

On January 13, 2022, he was advanced out of committee by a 13-8 vote. On February 15, 2022, the Senate confirmed his nomination by a 50-46 vote.[24][25] Califf assumed office on February 17, 2022.

Memberships

He is a member of the Institute of Medicine (IOM). He was on the committees that recommended, for example, Medicare coverage of clinical trials and to remove ephedra from the market, and the committee on identifying and preventing medication errors. As of 2015, he is a member of the IOM Policy Committee and liaison to the Forum in Drug Discovery, Development, and Translation.

He served on the FDA Cardiorenal Advisory Panel and FDA Science Board's Subcommittee on Science and Technology.[5]

References

  1. 1 2 Tavernise, Sabrina (19 September 2015). "F.D.A. Nominee Califf's Ties to Drug Makers Worry Some". New York Times. Retrieved 19 September 2015.
  2. 1 2 "Califf Wins Senate Confirmation Vote on FDA Top Spot". Medscape. February 24, 2016. Retrieved 2016-02-24.
  3. ↑ "Biden nominates Robert Califf as FDA commissioner". NBC News. 12 November 2021. Retrieved 2021-11-12.
  4. 1 2 3 4 5 6 Kroll, David (26 January 2015). "Duke's Rob Califf Named FDA Deputy Commissioner". Forbes. Retrieved 5 Feb 2015.
  5. 1 2 3 "Dr. Robert Califf named FDA Deputy Commissioner for Medical Products and Tobacco" (Press release). Food and Drug Administration. 26 January 2015. Retrieved 5 Feb 2015.
  6. 1 2 Husten, Larry (26 January 2015). "Califf To Leave Duke To Become FDA Deputy Commissioner". Forbes. Retrieved 5 Feb 2015.
  7. ↑ "Ex-FDA chief Robert Califf to help lead health policy at Google, Verily full-time". FierceBiotech. October 2019. Retrieved 2021-10-15.
  8. ↑ Califf, Robert (24 February 2009). "Robert Califf, M.D., Consultant for the ABC News OnCall+ Heart Disease Center". ABC News. Retrieved 5 February 2015.
  9. 1 2 3 4 "Duke Faculty Webpage". Archived from the original on 2015-02-06. Retrieved 2015-02-06.
  10. ↑ Massimo Calabresi (19 February 2015). "Candidate to Lead FDA Has Close Ties to Big Pharma". Time Magazine. Retrieved 30 October 2015.
  11. ↑ Elias, Jennifer (30 September 2019). "Alphabet taps former FDA commissioner to oversee health strategy and policy". CNBC. Retrieved 2023-01-19.
  12. ↑ Kolata, Gina (17 November 2014). "Study Finds Alternative to Anti-Cholesterol Drug". New York Times. Retrieved 11 February 2015.
  13. 1 2 Matthew Herper (16 September 2015). "Robert Califf Could Transform The FDA -- The Right Way". Forbes. Retrieved 30 October 2015. Califf was widely seen as too linked to industry.
  14. 1 2 Matthew Herper (26 January 2015). "Yes I do think this means Robert Califf will be the next FDA Commissioner" (blog). Forbes Pharma/Healthcare. Retrieved 29 October 2015.
  15. ↑ "Robert Califf, from Aug. 2013 to Dec. 2014". Dollars for Docs. ProPublica. n.d. Retrieved 29 October 2015. Payments: At a Glance 42 payments $52,796 payment total, Rank: 23 out of 564 doctors in this specialty and state 10 companies paid this doctor.
  16. ↑ "Executive Profile Robert M. Califf M.D". Bloomberg news. n.d. Retrieved 30 October 2015.
  17. ↑ Ndiaye, Fatou (29 October 2021). "Will Biden's FDA Be Led by a Pharma Guy?". The American Prospect. Retrieved December 24, 2021.
  18. ↑ Weixel, Nathaniel (14 December 2021). "Manchin, Sanders will oppose Biden FDA nominee Califf". The Hill. Retrieved 24 December 2021.
  19. ↑ Burton, Thomas (5 February 2015). "FDA Commissioner to Resign". Wall Street Journal. Retrieved 5 February 2015.
  20. ↑ "On the Nomination (Confirmation Robert McKinnon Califf, of South Carolina, to be Commissioner of Food and Drugs)". US Senate. Retrieved 15 March 2022.
  21. ↑ "Statement from President Joe Biden Announcing His Intention to Nominate Dr. Robert Califf for Commissioner of Food and Drugs". The White House. 12 November 2021. Retrieved 15 March 2022.
  22. ↑ Collins, Kaitlyn; Sullivan, Kate (12 November 2021). "Biden picks Dr. Rob Califf as FDA commissioner". cnn.com. Retrieved 13 November 2021.
  23. ↑ "PN1372 — Robert McKinnon Califf — Department of Health and Human Services 117th Congress (2021-2022)". US Congress. 3 January 2022. Retrieved 15 March 2022.
  24. ↑ "PN1593 — Robert McKinnon Califf — Department of Health and Human Services 117th Congress (2021-2022)". US Congress. 15 February 2022. Retrieved 15 March 2022.
  25. ↑ "On the Nomination (Confirmation: Robert McKinnon Califf, of North Carolina, to be Commissioner of Food and Drugs, Department of Health and Human Services)". US Senate. Retrieved 15 March 2022.
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