Califf skates through nomination hearing

Regulatory NewsRegulatory News | 14 December 2021 |  By 

Despite some rumbling about his ties to the pharmaceutical and tech industries, Robert Califf breezed through a two-hour nomination hearing on Tuesday for a second stint as commissioner of the US Food and Drug Administration (FDA).
Califf’s nomination by President Joe Biden last month came after a protracted period of speculation as to who would be chosen to lead FDA at an unprecedented time in the agency’s history. During the hearing, Califf laid out three overarching priorities he plans to take on, if confirmed, including emergency preparedness and the response to the COVID-19 pandemic, patient and consumer protection, as well as FDA modernization and innovation.
“When we get our prescriptions filled, or rely on medical devices to stay healthy, we count on FDA’s work to uphold the gold standard of safety and effectiveness. The FDA needs strong leadership to continue that work and to address other pressing challenges,” said Senate Committee on Health, Education, Labor and Pensions Chair Patty Murray (D-WA).
Hinting at Califf’s broad bipartisan support in his previous confirmation, Ranking Member Richard Burr (R-NC) said he is “thankful to finally have an opportunity to hold a hearing on one of the most significant positions in the administration, during the worst pandemic in over a century … I’m disappointed that it took so long, but I’m glad to see [Califf] here again sitting before this committee.”
Burr reminded Califf of the stark difference in the public health landscape since his previous time as FDA commissioner at the end of President Barack Obama’s second term. “You last led the agency during peacetime, we need a wartime commissioner who will lead us through the next phase of the response to coronavirus and build a stronger, more nimble FDA,” Burr said.
“My first priority, if confirmed, will be emergency preparedness and response. The FDA must continue to be a strong partner in battling COVID-19, taking into account lessons learned from the pandemic … so we are ready for the next one,” Califf said.
The former commissioner and real-world data proponent said his next priority will be to hone the agency’s focus on protecting patients and consumers. “Safety matters. Now is the time to develop a systematic approach to evidence generation that will improve patient safety and provide a much more efficient way to understand the benefits and risks of medical products when used in practice and to ensure that our food is safe,” he said.
Lastly, Califf emphasized the importance of keeping up with advances in science and technology to effectively regulate cutting-edge technologies and to provide guidance to industry on product development and best practices.
Califf fielded questions from senators running the gamut of FDA-related topics, including some controversial ones, including the agency’s role in addressing the opioid crisis, its accelerated approval program, antimicrobial resistance, complex generics, tobacco products and vaping, drug competition and pricing, and over-the-counter monograph reform.
When questioned by Burr about FDA’s accelerated approval program, which has drawn renewed criticism following the recent approval of Biogen’s Alzheimer’s drug Aduhelm (aducanumab), Califf offered a nuanced view in support of the program but said more needs to be done to review such products in the postmarket setting.
“I am a fan of accelerated approval for the right conditions,” Califf said, “The very fact of [the] accelerated pathway means that we’re accepting that there’s more uncertainty and the FDA has tremendous latitude about the decision it makes with those pathways, and that means we’ve got to have a better system to evaluate these products as they’re used on the market.”
Several lawmakers, including Sens. Maggie Hassan (D-NH) and Ben Ray Luján (D-NM), pressed Califf on the agency’s approach to opioids, insisting that he do more to curtail their prescribing for long-term use.
Califf ultimately agreed to a “comprehensive review of the status of opioids early in my tenure – like in the first few months, should I be confirmed – that would include everything, including the labels.”
Burr and several other Republican lawmakers pushed Califf to weigh in on the abortion drug mifepristone and whether the risk evaluation and mitigation strategy (REMS) for the drug should be “weakened.” Califf declined to give a specific answer, but said he trusts the staff at the agency would follow the evidence in any decision related to the drug.
The most adversarial moment in the hearing came when Sen. Bernie Sanders (I-VT) grilled Califf over his stock holdings and his close relationship with industry before and after his previous term as commissioner. Califf responded by saying that this administration has “the most stringent ethics pledge in the history of administrations” and that he has agreed to abide by it.
While a confirmation vote has yet to be scheduled, and several senators have said they oppose his nomination, Califf is expected to be confirmed with bipartisan support early in the new year.


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