Rob Califf, the Food and Drug Administration’s current second-in-command, has just been nominated by President Barack Obama to take over as its top executive.
A no-nonsense Southerner with a deep expertise in clinical trial policy, Califf, a top Duke University researcher and clinical trial specialist, is a natural choice for FDA Commissioner. Indeed, he has been eyed by the agency for several years.
Califf joined as the Deputy Commissioner for Medical Products and Tobacco at the FDA this past March – his first regulatory stint. He was actually appointed deputy commissioner right as former commissioner Margaret Hamburg stepped down.
Despite serving for less than a year at the agency, 63-year-old Califf is regarded an expert in clinical trials and well-versed in FDA policy. He’s served on several FDA expert committees and has been considered for the commissioner’s role twice before – under both the George W. Bush and Obama administrations.
Nature actually profiled Califf in February when it was announced he’d join as deputy commissioner. It pegged him a soft-spoken, no-nonsense kind of guy – with a reputation for not wasting people’s time.
“He is a big get for the FDA,” Ellen Sigal, founder and chair of Washington, D.C., think tank Friends of Cancer Research, told Nature. “People are very excited about him coming.”
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
His initial work in large clinical trials was with friend and fellow cardiologist Eric Topol, working on a landmark 41,000 patient study of heart attack medications. Since, he’s worked on several large-scale clinical trials during his tenure at Duke, and worked with the FDA on policy. Nature continues:
That clinical-trial expertise will be a particular boon, says Sigal, because the FDA will increasingly be asked to adapt to the growing era of ‘precision medicine’ — treatments tailored to an individual patient’s specific characteristics, such as genetic makeup. Such therapies often call for a different approach to clinical trials, such as tailoring trials for smaller numbers of patients, and matching patients’ genetic profiles to treatments.
Califf’s nomination still needs to be approved by Congress to become official. However, because Califf is generally eyed as such a shoo-in for the job, the nomination process should go smoothly, the Wall Street Journal writes:
His nomination isn’t expected to be controversial in the Senate, which must vote to confirm him to the post. “Unless they’re looking for a reason to slow this down to score points, he should get relatively quick approval,” said one federal official who deals frequently with Congress.
In a Twitter posting, NIH Director Francis Collins referred to Califf as a “superb physician scientist.”
