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10/12/2015

An F.D.A. Commissioner With Ties to the Pharmaceutical Industry? Heaven Forbid?

On September 16, 2015, President Obama nominated the internationally known Duke University cardiologist-researcher Robert M. Califf, MD, to be Commissioner of Food and Drugs. He will replace Margaret Hamburg, MD, who left the agency last March. Dr. Califf – a registered Democrat but well regarded by Senate Republicans – has served as Deputy Commissioner at the F.D.A. since February. The Senate must confirm the commissioner.

Immediately prior to joining the F.D.A., Dr. Califf was professor of medicine and vice chancellor for clinical and translational research at Duke. While at Duke, he founded the Duke Clinical Research Institute and served as director of the Duke Translational Medicine Institute. A highly esteemed expert in cardiovascular medicine, health outcomes research, healthcare quality, and clinical research, Dr. Califf has led many landmark clinical trials and authored or co-authored over 1,200 publications in the peer-reviewed literature. He is one of the American Medicine’s most frequently cited authors in the biomedical sciences. His credentials are unimpeachable. Two of Dr. Califf’s area of interests are improving the design of drug research projects and streamlining the regulatory process to bring innovative drugs to market more quickly.

However, he also has many strong ties to the pharmaceutical and medical device industries. One article called him the ultimate drug industry insider.

It may seem logical to be suspicious of having a F.D.A. Commissioner who understands clinical drug research inside and out. After all, Dr. Califf learned much by working with drug and device manufacturers over the years, directing a clinical research trials center with an annual $200 million budget and with 65% of that amount coming from big pharma.

But potential conflicts are interest are not real conflicts of interest. And potential conflicts of interest are manageable. In fact, he undoubtedly acquired a good deal of experience managing the conflicts of interests of others transparently when he was director of the Duke Clinical Research Institute. Potential conflicts of interest are not disqualifying. The F.D.A. and the American people may gain much from someone with Dr. Califf’s remarkable experiences as commissioner. 

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI’s online graduate programs, please visit our website.

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