The U.S. Food and Drug Administration (FDA) “must continue to be a strong partner in battling COVID,” while also using what we learned from the pandemic, said Dr. Robert Califf during the Senate hearing on his nomination for FDA Commissioner—here’s more on what he said will be his priorities if confirmed.
The background: Dr. Califf was President Obama’s FDA Commissioner for 11 months in 2016. He was questioned for two-and-a-half hours yesterday by the Senate HELP Committee, receiving respect for his past tenure and a few pointed questions about his industry ties and the FDA’s opioid crisis response.
“The pandemic is priority number one,” Dr. Califf said in his opening statement. “Not just this pandemic, either. I am fully aware of the need for the FDA to help develop platforms that will be ready to go when future emergencies arise.”
On antimicrobial resistance (AMR): “We have got to figure out how to get a handle on this,” said Dr. Califf when asked for his view about how FDA can help improve the flawed antibiotic market by Sens. Bob Casey (D-PA) and Bill Cassidy, M.D. (R-LA) (who have both cosponsored legislation to help).
Read/Listen: Antimicrobial Resistance: The Silent Pandemic
On accelerated approval: “I am a fan of accelerated approval for the right conditions,” in particular for “serious diseases for which there is no treatment,” said Dr. Califf. However, that can mean “more uncertainty,” which the FDA must address using data to evaluate products once they’ve reached the market. “Technology is making this possible in ways that it wasn’t possible before,” he said. (Ranking Member Richard Burr (R-NC) spoke about the importance of maintaining accelerated approval in his opening remarks.)
There was a preview of the PDUFA VII negotiation of drug user fees, which the next commissioner will oversee. Ranking Member Burr noted that, currently, 55% of the FDA’s budget is approved through Congressional appropriations, and 45% from user fees.
“This growth in user fees from industry weakens FDA’s accountability to Congress, and to the patients we serve,” said Sen. Burr. “This is the most important user fee cycle this Committee has faced,” Burr said, vowing the process for setting fees expiring in 2022 will be “vastly different” from previous years.
The criticism: Some Senators focused on Dr. Califf’s ties to the pharmaceutical industry, and his leadership at the FDA during the opioid crisis, which continues to devastate America today. He said addressing the crisis will be a priority, vowing to “work with the public health, clinical and policy communities to turn the tide.”
The next steps: Dr. Califf, approved 89-4 in 2016, seems a safe choice to provide stable leadership at the FDA, which has had seven commissioners and acting commissioners since 2015. He appears to have bipartisan support, as well as the endorsement of six former FDA Commissioners, per The Washington Post. He could be confirmed in early 2022.
And as a reminder, the "F" in FDA stands for "Food." BIO urges the agency to commit to working with USDA and the White House to develop efficient, risk, and science-based regulatory systems that can create a safe and predictable path to market for innovations in animal biotech. While the topic was not broached during Dr. Califf's hearing, BIO continues to work closely with the administration to ensure innovations, like disease-resistant, climate-resilient animals to sustainably increase protein production, have a path to market.
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