Califf, 64, is a well-regarded cardiologist and researcher who takes the helm at the FDA at a time it is under pressure from lawmakers to speed the approval process for drugs and medical devices and finalize a proposed rule giving it authority to regulate e-cigarettes.The agency is also attempting to implement sweeping new regulations to improve food safety, and has begun to tackle the approval process for biosimilars, which are cheaper versions of biologic drugs.
Califf’s nomination was opposed by the Democratic presidential candidate Bernie Sanders, who said Califf’s ties to the pharmaceutical industry made him unfit to regulate the industry impartially. It was also opposed by several senators who believe the agency needs to do more to combat opioid addiction.Several senators, including Democrat Edward Markey of Massachusetts and Joe Manchin of West Virginia, took the opportunity leading up to the vote to lambaste the FDA for what they said was a lax approach to approving potentially addictive opioid painkillers.
