Senate confirms Dr Robert Califf to lead FDA
pharmafile | February 25, 2016 | Appointment | Medical Communications | Drug pricing, FDA, Robert Califf
The US Senate has confirmed Dr Robert Califf as Commissioner of the Food and Drugs Administration, in an overwhelming 89-4 vote held February 24.
The four senators voting against Califf’s appointment were Republican Kelly Ayotte; and Democrats Richard Blumenthal, Joe Manchin and Ed Markey, although two senators – Democrat Bill Nelson and Republican Rob Portman – who had opposed the 64 year old in Monday’s procedural vote, changed their minds for the final vote.
After his nomination for the role by President Obama, opposition to Califf, a cardiologist who has served as Deputy Commissioner of the FDA for the past year, held up his confirmation for five months. It came largely as a result of what was perceived as a cosy historic relationship with the pharmaceutical industry that he will now regulate. During his 30 years at Duke University, he founded a $200 million research institute, largely funded by pharma, and received thousands of dollars in consulting fees.
However, Califf has denied this effects his ability to perform effectively and impartially in the Commissioner role, saying “the American public completely depends on having confidence that the FDA is independent.”
Commenting on the appointment, Acting FDA Commissioner, Stephen Ostroff, says: “Dr Califf has demonstrated a long and deep commitment to advancing the public health throughout his distinguished career as a physician, researcher, and leader in the fields of science and medicine. He understands well the critical role that the FDA plays in responding to the changes in our society while protecting and promoting the health of the public, across the many areas we regulate – and I am confident that our public health and scientific contributions will further grow under his exceptional leadership.”
Califf takes the helm at the FDA at a time when prescription drug pricing is a topic of controversy, and with the Administration under pressure to speed the regulatory pathway to drug approvals, despite the fact that the number of drugs cleared last year was at its highest level for decades at 45.
One matter on his agenda will be refining and clarifying on the approval process for biosimilars – cheaper versions of biological drugs: the use of which offers the potential to save considerable sums of money in the healthcare system.
Joel Levy
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