At Pivotal Moment in Public Health, FDA Needs A Strong Leader
The US is at a pivotal moment in terms of public health. Congress is gearing up for the next PDUFA reauthorization, landmark biomedical legislation is being considered from both the House and Senate, the President’s Precision Medicine Initiative is improving treatments and the Vice President is leading a “Cancer Moonshot” to eradicate this disease. Congress and the Administration look to make strides on these issues in 2016 and the Food and Drug Administration (FDA) will play a critical role in moving these initiatives forward. Yet politics is preventing the agency’s highly qualified nominee from being confirmed as FDA commissioner.
Dr. Robert Califf, President Obama’s nominee for FDA Commissioner, is not only well qualified, but has received broad support across the aisle. His in-depth confirmation hearing led to a unanimous vote from the Senate HELP Committee for his nomination to advance to the Senate floor.
Dr. Califf will bring the paramount leadership necessary to FDA and continue assuring the safety, efficacy and security of treatments while also helping to speed innovation. Before being appointed to his current position as FDA Deputy Commissioner for Medical Products and Tobacco, Dr. Califf was Vice Chancellor of Clinical and Translational Research at Duke University. While at Duke, he led numerous landmark, clinical studies that resulted in life-saving medical innovations. He is widely recognized as an expert in cardiovascular medicine, health outcomes research and translational research, which is key to making sure advances in science translate effectively to medical care.
Additionally, Dr. Califf knows how to maximize effectiveness for patients through FDA work. He has vast experience working with the agency, serving as a member of the FDA Cardiorenal Advisory Panel and FDA Science Board’s Subcommittee on Science and Technology before his current appointment. A good commissioner must be able to work with all sectors to see a drug through development to approval, and Dr. Califf has both the expertise and working relationships in and out of FDA to do just that.
More importantly, the patient advocacy community has joined the President in putting their confidence behind Dr. Califf. Numerous groups have come together to voice their support for his nomination by noting his vast experience, important working knowledge of the regulatory environment and his commitment to bring effective treatments to patients as quickly and safely as possible.
“This is a very important choice at this time to carry out the mission of an agency that keeps the country safe and gets new therapies to those that need them most.” — Ellen Sigal, chair of Friends of Cancer Research (The Washington Post, September 15, 2015)
Right now politics is standing in the way of providing better care to patients. Currently, five US Senators* are threatening to block Dr. Califf’s confirmation for various reasons. These issues, while important, deserve serious discussion and are inappropriately being used in this case to halt the nomination of a leader taking the reins of an agency that aims to protect patients. The FDA needs a strong commissioner with broad support at such a pivotal time. Congress must ensure that FDA continues its important mission to provide patients with safe and effective treatments. We ask the Senate to put politics aside to do what is right by patients and immediately confirm Dr. Robert Califf as FDA commissioner.
*Sen. Bernie Sanders (D-VT), Sen. Lisa Murkowski (R-AK), Sen. Edward Markey (D-MA), Sen. Joe Manchin (D-WV) and Sen. Kelly Ayotte (R-NH)