HELP Committee Unanimously Supports Califf Nomination
FDA commissioner-nominee Robert Califf won an unanimous voice vote from the Senate Health, Education, Labor, and Pensions (HELP) Committee 1/12 to approve his nomination to become the next commissioner. The nomination now moves to the Senate floor for a full vote.
Before the vote, HELP Committee chair Lamar Alexander (R-TN) said he and his staff have carefully reviewed Califf’s qualifications and the nomination has been properly vetted. He said he sees nothing to question Califf’s ability to lead the agency fairly and impartially. Ranking member Patty Murray (D-WA) had this to say: “From his history of leadership and management experience, to his record of advancing medical breakthroughs on challenging illnesses through clinical trials, and his commitment to transparency in relationships with industry, Dr. Califf’s record has made clear that he will be a strong, independent FDA commissioner. And I believe he will contribute leadership and expertise as we work to find new ways to advance medical innovation, and improve the health and wellbeing of families across the country.”
Senator Lisa Murkowski (R-AK), who recently said she will seek to block Califf’s confirmation due to lack of FDA cooperation and communication after its announcement to approve genetically engineered (GE) salmon, continued her opposition to the nomination. She announced her intention to block confirmation proceedings if her concerns are not resolved. Murkowski made clear that she wants assurance from the FDA that it will require mandatory labeling of GE salmon as it becomes available for human consumption.
Meanwhile, Califf recently provided written responses to several HELP Committee members additional questions. In a response to questions from Alexander, Califf said that if confirmed he would make the following high priorities to ensure the agency is not a barrier to innovation:
“Reform the clinical trials system, using the principle of Quality by Design, so that a combination of small, focused trials for precision medicine and very large trials using electronic health records for inclusion of important populations can be conducted at a dramatically lower cost per unit of knowledge. The small precision medicine trials are lower cost because of lower sample size and the very large, inclusive trials will be lower cost because they will take advantage of data already collected and the novel methods of community-based research. FDA’s Sentinel project is an excellent building block with claims data on over 170 million Americans available to evaluate the safety of drugs and biologics, but the same system with modifications could be used to dramatically reduce the cost of data collection in clinical trials. Direct involvement of patients will also enable us to streamline, because a more involved public, together with more trials relevant to the needs of patients will lead to faster enrollment.
“A second key approach is to continue to improve the communication between FDA and the scientific community. In every case where FDA has offered more meetings with sponsors, the opportunity has been over-subscribed. In addition, public-private partnerships have been highly successful in promoting multi-sector dialogue and developing a common view of key issues in medical product development, including the Medical Device Innovation Consortium and the Clinical Trials Transformation Initiative.
“Finally, effective interactions between FDA and its federal partners can be an important factor in maintaining the appropriate standard while reducing the cost of medical product development. The FDA-National Institutes of Health (NIH) Leadership Council is a successful collaboration between FDA and NIH, focused on clarifying the biomarker-surrogate-clinical outcome continuum and streamlining clinical trials.”