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In the area of medical apps, Dr. Califf said there needs to be more clarity as to where the line for regulation should be. As an example, he said that an app that monitors heart rate does not need much oversight, but if that app were connected to an implantable defibrillator, that would require more regulatory oversight.
Sen. Sanders cited Dr. Califf’s ties to the pharmaceutical industry as the prime reason for opposing the nomination.
Dr. Califf noted that for any of the research he had conducted, even when primarily funded from industry, he was clear that manufacturers, while being able to make suggestions for analysis and publication of results, did not have final say, and he said that numerous studies were rejected because companies would not agree to full access to databases or independence with the final publication of results.
One area that was not raised during the hearing, but was raised by the Project on Government Oversight regarding the ROCKET AF trial of rivaroxaban (Xarelto), for which he was co-primary investigator (N Engl J Med. 2011 Sep 8;365:883-91).
“Dr. Califf’s handling of the Xarelto trial raises concerns about his judgment in overseeing the pharmaceutical industry.” POGO Executive Director Danielle Brian said in a statement. “As senators consider Dr. Califf’s confirmation to run the FDA, they should ask tough questions about the Xarelto clinical trial.”
FDA primary reviewers recommended against approval based on a number of issues with the trial, but FDA ultimately decided in favor of bringing the drug to market.
A cardiologist by training, Dr. Califf has received support from the American College of Cardiology.
In an Oct. 21, 2015, letter to the Senate HELP Committee, ACC called Dr. Califf “the right person to lead the FDA as commissioner based on his impressive medical knowledge, clinical research experience, and visionary leadership abilities.”
Dr. Califf joined the FDA in February as deputy commissioner of medical products and currently provides executive leadership to FDA’s Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, and the Center for Tobacco Products.
He also oversees FDA’s Office of Special Medical Programs and plays a critical role in providing high-level advice and policy direction on the agency’s medical product and tobacco priorities.
Prior to coming to FDA, he was vice chancellor of clinical and translational research and professor of medicine in the division of cardiology at Duke University in Durham, N.C. He has held multiple positions at the university, including director of the Duke Translational Medicine Institute and founding director of the Duke Clinical Research Institute.
He also served as a member of FDA’s Cardiovascular and Renal Drugs Advisory Committee and the agency’s Science Board Subcommittee on Science and Technology.
“We believe that with Dr. Califf’s diverse background, and his exemplary knowledge of clinical and translational medicine, he will continue to improve the FDA’s drug approval process while ensuring that patients are receiving the safest and most effective treatments as quickly as possible. We urge his immediate confirmation,” a coalitions of 50 medical and advocacy groups, including the American Academy of Pediatrics, American Society of Clinical Oncology, American Association of Cancer Research, National Organization for Rare Disorders, and the Personalized Medicine Coalition, said in an Oct. 29, 2015, letter to the Senate HELP Committee.