Despite an intense flurry of pushback, the U.S. Senate voted Wednesday to confirm cardiologist Robert Califf as the next commissioner of the FDA. The Senate had passed a procedural vote two days prior, but several senators had held up the final vote the following day in an effort to push the agency to be more engaged in its review of opioid analgesics.
Their efforts delayed by 24 hours a final 89-4 vote affirming the Obama administration's nomination, putting Califf at the helm as the FDA faces new programs from both the White House and Congress that will stretch the agency's resources in the years to come.
The bipartisan group of legislators who led the Feb. 23 charge, led by New Hampshire Republican Kelly Ayotte and Massachusetts Democrat Ed Markey, had argued that prescription opioids are feeding an epidemic of drug overdoses that is claiming tens of thousands of American lives each year. (See BioWorld Today, Feb. 24, 2016.)
Beyond the opioid issue, Califf had faced considerable opposition from the time the White House announced his candidacy. Some critics alleged that Califf's time at the Duke Clinical Research Institute had created an inappropriately cozy relationship with the pharma industry, although others asserted that Califf's experience in clinical trial design and execution made him singularly qualified to lead what is seen in some quarters as a dire need to overhaul the agency's approach to clinical trials.
As the vote was about to commence, Sen. Patty Murray (D-Wash.) urged her colleagues to vote for Califf as the 22nd commissioner of the FDA, stating she had the confidence that Califf's qualifications "will allow him to lead the FDA in a way that puts patients and families first." Murray stated further that Califf "has made clear that he will continue to prioritize independence" and will "put science over politics." She noted that Califf will be tasked with overseeing the implementation of the medical device postmarket surveillance system and promised he will ensure that the agency is "playing a part in the epidemic of opioid abuse."
Among the affirmative votes Sens. Amy Klobuchar (D-Minn.) and Rob Portman (R-Ohio), both of whom had voiced reservations about the agency's handling of the opioid analgesic predicament, while Democrats Richard Blumenthal (Conn.), Joe Manchin (W.V.) and Markey all held the nay vote line.
Among the organizations that hit the wires with statements at the conclusion of the vote was Friends of Cancer Research, which stated, "we are at a critical moment in public health, and it is paramount to have a strong leader at the helm of the FDA," a statement attributed to Ellen Sigal, the group's founder and chairwoman.
The erstwhile acting FDA commissioner Stephen Ostroff said Wednesday that Califf "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."
Janet Trunzo, executive vice president for technology and regulatory affairs for the Advanced Medical Technology Association, said, "We are pleased that today's Senate vote confirming Dr. Califf as the new FDA commissioner will provide permanent leadership to this vital agency that does so much to protect and promote the public health. We look forward to working with the new commissioner to ensure that American patients have timely access to the life-saving and life-enhancing innovations our industry provides," Trunzo concluded.
Mark Leahey, president and CEO of the Medical Device Manufacturers Association (MDMA), said Califf's leadership "will play a prominent role in determining how successful" industry will be in "developing safe and effective therapies and cures for the 21st Century."
Biotechnology Innovation Organization President and CEO Jim Greenwood said Califf's confirmation "comes at a time of tremendous advances being made in biotechnology and regulatory science." Greenwood said he is "confident that [Califf] will provide the stability, leadership and confidence the public seeks from an agency entrusted with such a critical mission."
Steve Ubl, formerly the president and CEO of Advamed and now holding the same position with the Pharmaceutical Research and Manufacturers of America, said PhRMA "congratulates Dr. Robert Califf on his confirmation," adding that a permanent commissioner "is critical to the agency's continued ability to fulfill its public health mission and to bring new cures and innovative therapies to patients in need."