|Dr. Robert Califf|
Robert Califf, President Barack Obama's pick to lead the FDA, handily won Senate confirmation Wednesday, clearing him to take the reins at the agency.
In a vote of 89-4, senators signed off on Califf's nomination, ignoring vocal criticisms from a handful of lawmakers concerned about his ties to the pharma industry and with the FDA's policies on approving painkillers.
Califf, who is currently deputy FDA commissioner for medical products and tobacco, will now inherit a regulator in transition. Under former chief Margaret Hamburg, the agency approved record numbers of new drugs and unveiled programs designed to speed the path of promising medicines, working with industry to make the approval process more efficient. But those moves proved controversial among critics who contend the agency's relationship with pharma has put patients at risk.
The debate over Califf's nomination reflected those concerns, as a group of senators led by Edward Markey (D-MA) and Joe Manchin (D-WV) threatened to block his confirmation until the FDA reconsiders its policy on opioid painkillers. Similarly, Sens. Bernie Sanders (I-VT) and Lisa Murkowski (R-AK) challenged Califf's nomination over what they perceived as a cozy relationship with the industry, established in his years as the head of Duke University's in-house CRO, which runs trials for drugmakers.
Under Hamburg's regime, the agency approved a powerful hydrocodone product called Zohydro, sparking outrage among public health advocates who warned that the availability of such a drug would only stoke the scourge of opioid abuse in the U.S.
Califf, inheriting that controversy, has already moved to address senators' concerns about how the agency regulates opioids, putting out an 8-point plan that calls for re-examining how the FDA regulates painkillers. Califf has promised that the agency will re-examine how it weighs risks versus benefits for oft-abused drugs, bringing in outside experts to shed light on the possible dangers of approving increasingly powerful analgesics.
Califf, a cardiologist by training, has been up for the top job at the FDA since 2014, when ex-director Margaret Hamburg named him deputy. Obama made his nomination official in September.
Before joining the FDA, Califf served as the founding director of the Duke Clinical Research Institute, which employs more than 1,000 people and has an annual budget of more than $100 million, according to the school.
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