Dr. Robert Califf, a cardiologist and researcher of Duke University, has officially been confirmed by the US Senate as the new head of the Food and Drug Administration by a vote of 89-4. The confirmation comes after a drawn-out process when President Barack Obama first nominated Dr. Califf as his choice in September of last year. The last FDA chief, Dr. Margaret Hamburg, stepped down in March of 2015.

Though debated by some opposition members because of his ties as a researcher to pharmaceutical companies, Dr. Califf’s nomination was  supported by 135 organizations, including the American Heart Association, and endorsement by the New England Journal of Medicine.

In his initial confirmation hearing, Dr. Califf has proposed several priorities and plans of action for his role as FDA chief. These include a two tier system for streamlining clinical trials, for cost and time reduction so American patients will have quicker and more affordable access to new medications, while still maintaining high safety standards. the system would include smaller trials that are more limited and focused for medications predicted to make large impact on small populations, and larger trials using electronic heath records and social media. Major issues ahead for the FDA will include the backlog on approval of generic drugs, food safety issues, the opiod crisis, and the debate with pharmaceutical companies over the standard for off-label uses.

Dr. Califf served as the keynote speaker for the 19th Annual Scientific Sessions of the Heart Failure Society of America in September of 2015. During the opening plenary session, The Economic Model of Heart Failure Care, Dr. Califf addressed these key points:

• Healthcare decisions are best made when we have solid evidence to define the benefits and risks of the options.
• The simultaneous revolutions in biomedical science, information science, and patient/consumer empowerment make a new day possible.
• Without good evidence, the chances of waste and harm are substantial.
• Clinicians, together with the patients they care for, need to step up their participation in evidence generation.

Dr. Califf spoke to the Washington Post regarding his confirmation and his first two priorities, which include recruiting and retaining talent for the FDA, and bolstering the scientific infrastructure. "For me, my career has been developing and evaluating therapies. I think I’m in a great position to help motivate the collaboration that’s needed across society to have a system where we have much better information, and where it’s explained in a way that people can make better decisions. I intend to take every opportunity to that -- even in audiences that may have concerns about specific decisions the FDA makes -- so we can get out there and hear what they have to stay, and also they make sure they understand why we’re doing what we’re doing."