After 4 months of delay, the U.S. Senate today approved cardiologist and clinical trialist Robert Califf, President Obama’s pick to head the Food and Drug Administration (FDA). Califf, whom critics have labeled an industry insider for his role overseeing large company-funded trials at Duke University Medical Center in Durham, North Carolina, will take the helm as the agency faces pressure from Congress to speed the approval of medical products to patients.
The nomination, announced last September, has faced several lines of opposition, some of which have little to do with Califf himself or his qualifications. Senators Edward Markey (D–MA) and Joe Manchin (D–WV) have both used the nomination as a chance to express frustration with FDA over its response of the epidemic of opioid abuse—to argue that the agency has been too permissive in its approval of prescription opioids, and has failed to consult its scientific advisory board in those decisions. Ill will toward the agency over its approval of genetically modified salmon last November led Senator Lisa Murkoswki (R–AK) to block the nomination and demand that FDA put out guidelines requiring the fish to be labeled. (Murkowski later lifted her hold.) And Senator Bernie Sanders (D–VT) also blocked the nomination, citing concerns that Califf wouldn’t be motivated to help combat the rising cost of prescription drugs.
That opposition was blunted by a procedural vote on Monday, which limited the remaining floor debate on the nomination. And the Senate today approved the nomination today by a vote of 89 to four.
It remains to be seen how Califf’s decades-long working relationship with drug sponsors might influence his role as a regulator. But his confirmation comes as legislators in both the House of Representatives and Senate push for changes to FDA’s review process to speed the approval of new drugs and devices. The new commissioner, who has been a proponent of so-called pragmatic clinical trials, designed to gather more useful data by observing broad populations in real-world settings, said in his November 2015 confirmation hearing that streamlining clinical trials would be among his priorities.