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General agreement that FDA needs a confirmed commissioner may speed Califf’s appointment.
The Biden administration’s choice to lead FDA successfully navigated a Senate confirmation hearing on December 14, setting the stage for full Senate approval early next year. The leading Republican on the Senate Health, Education, Labor and Pensions (HELP) committee, Sen. Richard Burr, praised the stellar academic and medical research credentials of his fellow North Carolinian, eliciting support from other Republicans on the panel. HELP Committee Chair Patty Murray (D-Wash.) set the stage for a speedy conclusion to the vetting process and votes on Califf’s confirmation in early January.
The main opposition to Califf came from Democrat Sen. Bernie Sanders (I-Vt), who questioned the nominee’s long ties to the drug industry and involvement in industry research that has generated high-priced medicines. At the same time, Califf received letters of support from six former FDA commissioners and a long list of academic, public health, and patient organizations. The nominee, who headed FDA in 2016, said he would hit the ground running and noted the importance of working closely with Congress and other federal health agencies.
The main point of controversy during the two-hour hearing centered on FDA approval of opioids leading to the addiction and hundreds of thousands of deaths from drug overdoses. Califf promised irate Senators from New Mexico and New Hampshire that he would take a “very aggressive approach” toward opioids and conduct a “comprehensive review” of their status and labeling as a first order of business.
In a brief statement, Califf outlined his top priorities as building on the lessons learned from this pandemic to ensure readiness for future health emergencies; ensuring the safety and effectiveness of regulated products, including tobacco and opioids; and ensuring that FDA stays current with the latest advances in science and technology. During the hearing, Califf highlighted his aim of working with sponsors to make better use of health records and real-world data to gain evidence able to support regulatory decisions and track medical conditions. He noted his long-time work to develop better systems for generating reliable evidence to support regulatory decisions. He and his supporters have emphasized that Califf’s experience in managing clinical trials for sponsors of new therapies enhances his ability to modernize practices and policies for developing and overseeing new, advanced treatments.
General agreement that FDA needs a confirmed commissioner is slated to speed Califf’s appointment. Both the nominee and Senate HELP leaders also praised the strong leadership at FDA provided by Janet Woodcock this past year and are waiting to see how and whether she remains at the agency under Califf.
Jill Wechsler is Washington editor for BioPharm International.