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Last September, President Barack Obama nominated cardiologist Dr. Robert Califf to be the next commissioner of the Food and Drug Administration (FDA).[1] Since the announcement, Public Citizen has voiced strong opposition to Califf’s nomination,[2] citing his well-documented history of extensive financial ties to multiple drug and medical device companies during his career at Duke University.[3] Unfortunately, on Feb. 24, the Senate confirmed his nomination.
Not surprisingly, some...
Last September, President Barack Obama nominated cardiologist Dr. Robert Califf to be the next commissioner of the Food and Drug Administration (FDA).[1] Since the announcement, Public Citizen has voiced strong opposition to Califf’s nomination,[2] citing his well-documented history of extensive financial ties to multiple drug and medical device companies during his career at Duke University.[3] Unfortunately, on Feb. 24, the Senate confirmed his nomination.
Not surprisingly, some Califf defenders have argued that his long history of working closely with the pharmaceutical industry is actually a big plus, providing him with an in-depth understanding of how drug development and marketing works.
For example, one Public Citizen supporter who states that he has worked with Califf criticized our opposition to his nomination, claiming that our stance seems to be based primarily on the fact that much of Califf’s research had been funded by the drug industry. The supporter asked, “Wouldn’t it be great to have [an FDA head] who knows thoroughly the workings of drug development and marketing?”
While we expect a nominee for the post to be familiar with FDA-regulated industries, Califf’s ties far exceed what is appropriate.
Importantly, Califf’s ties to Big Pharma are far more extensive than participation in industry-funded clinical trials. Indeed, during his more than 30 years at Duke,[4] he established a remarkable web of financial relationships with drug and medical device companies that is unprecedented among nominees for FDA commissioner.
For example, in the previous three years alone, Califf received personal fees for consulting from at least 19 major pharmaceutical manufacturers, including AstraZeneca, GlaxoSmithKline, Merck, Novartis and Pfizer.[5] Likewise, from 2006 to 2015, he served as a board member of and consultant to Faculty Connection, a company that has provided a wide array of services to the pharmaceutical, biotechnology and medical device industries.[6],[7] Among the many services promoted by Faculty Connection is regulatory consulting, including strategic input on regulatory interactions with the FDA.[8] In one of the company’s promotional videos, a board member asserts, “We have worked with over 175 different pharma, biotech and medical device firms.”[9] As a prolific industry consultant, Califf undoubtedly helped companies navigate the FDA review process and spin their messaging as they sought approval for potentially lucrative new drugs.
It would be dangerously naïve to think that Califf has not developed deeply ingrained attitudes that favor the interests of the drug and medical device industries or that he can readily divorce himself from the biases nurtured by the pervasive industry relationships that he has amassed over his career. Americans would have been much better served by an FDA commissioner without such deeply rooted financial ties to regulated industries.
References
[1] The White House Office of the Press Secretary. President Obama announces more key administration posts. September 15, 2015. https://www.whitehouse.gov/the-press-office/2015/09/15/president-obama-announces-more-key-administration-posts. Accessed February 15, 2016.
[2] Public Citizen. Senate should reject President’s nominee to be the next FDA Commissioner: Statement of Dr. Michael Carome, Director, Public Citizen’s Health Research Group. September 16, 2015. http://www.citizen.org/pressroom/pressroomredirect.cfm?ID=5635. Accessed February 15, 2016.
[3] Calabresi M. Candidate to lead FDA has close ties to Big Pharma. February 19, 2015. Time. http://time.com/3714242/candidate-to-lead-fda-has-close-ties-to-big-pharma/. Accessed February 15, 2016.
[4] Duke Clinical Research Institute. 2015 News Archives. Duke’s Robert Califf named as deputy FDA commissioner. January 26, 2015. https://www.dcri.org/research/news/2015-news-archives/dukes-robert-califf-named-as-deputy-fda-commissioner. Accessed February 17, 2016.
[5] Califf R. International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. January 28, 2016. Submitted for: Califf RM, Woodcock J, Ostroff S. A proactive response to prescription opioid abuse. N Engl J Med. February 4, 2016. DOI: 10.1056/NEJMsr1601307. http://www.nejm.org/doi/suppl/10.1056/NEJMsr1601307/suppl_file/nejmsr1601307_disclosures.pdf. Accessed February 16, 2016.
[6] Fang L. FDA nominee helped medical industry find and pay faculty for “regulatory consulting.” October 15, 2015. The Intercept. https://theintercept.com/2015/10/15/robert-califf-fda/. Accessed February 16, 2016.
[7] Faculty Connection. About us. http://www.faculty-connection.com/about-us/. Accessed February 16, 2016.
[8] Faculty Connection. Expertise: Clinical specialties. http://www.faculty-connection.com/expertise/. Accessed February 16, 2016.
[9] YouTube. Why you should work with Faculty Connection. https://www.youtube.com/watch?v=nF2DbKxnT6A. Accessed February 16, 2016.
