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Mending Trust on Tap for Next FDA Head as Clock Ticks on Nominee

Nov. 5, 2021, 2:00 PM

A new permanent commissioner at the Food and Drug Administration will need to bring more clarity to the government’s pandemic response and restore trust to an agency that remains without a Senate-confirmed leader nearly a year into the Biden administration, policy analysts and former FDA officials say.

President Joe Biden has just weeks left to name a replacement for acting Commissioner Janet Woodcock, who was ruled out for the post due to opposition on Capitol Hill. Installing a permanent head is seen as necessary to bring a steady presence amid the ever-evolving conditions of the pandemic.

“It’s hard to have a vision and goals that you want to achieve as an acting commissioner; you’re more just keeping the ship steered in the right direction,” former FDA Deputy Chief of Staff Kalah Auchincloss said. “The confirmed commissioner is more likely to have a thought about what direction the ship should go in and potentially change directions.”

Pressure to name a new leader is mounting as the FDA continues its review of Covid-19 vaccines and boosters. Former FDA Commissioner Robert Califf, who served in the final year of the Obama administration, is being reported as the top contender to lead the agency once again.

Industry insiders say that a new head will be tasked with addressing concerns over the FDA’s independence and credibility, which lawmakers and the general public have called into question over the past 20 months.

Beyond the pandemic, a new FDA commissioner will have the freedom to address individual priorities. An FDA head could help promote the use of real-world evidence in drug applications and expedite the approval process for low-cost biosimilar and generic drugs.

Woodcock will be forced to leave her role if the White House doesn’t announce a nominee by Nov. 15, but she can keep serving as acting commissioner if a nominee is in place by then.

An Evolving Role

Covid-19 has pushed the role of the FDA to the forefront, increasing both public understanding of the agency’s responsibilities in a public health crisis and scrutiny over its effectiveness, analysts say.

The FDA has authorized three Covid-19 vaccines for emergency use in the U.S. and has since granted full approval to Pfizer Inc.‘s shot for people ages 16 and older. The agency has authorized booster doses of each of the three vaccines, and most recently granted an Emergency Use Authorization (EUA) for the Pfizer vaccine for children ages 5 to 11. It’s also greenlighted more than 400 Covid-19 diagnostic tests and collection kits.

The pandemic has given the FDA an opportunity to more clearly demonstrate its agency responsibilities to the general public. Some “missteps” in the government’s initial response to the pandemic, however, have led to “a significant amount of credibility lost” to the FDA, Auchincloss argued.

Auchincloss, who worked closely with both Califf and former President Donald Trump’s first confirmed FDA Commissioner Scott Gottlieb, said there was a “lack of cohesive” government messaging on the importance of testing in the pandemic’s early months. She also noted that Gottlieb’s successor, Stephen Hahn, wasn’t immediately named to the White House Coronavirus Task Force.

“I can’t think of another public health emergency in which the FDA has been left out of it,” she said.

Other controversies have also surrounded the federal regulatory agency, including questions over whether there was influence from the White House to clear booster shots. Two top FDA vaccine experts decided to leave the agency this year as it was considering Biden’s booster plan. They didn’t publicly announce a reason for their departures.

The FDA also attracted backlash from lawmakers and others over its approval of Biogen Inc.’s Alzheimer’s drug Aduhelm despite objections from agency advisers. The approval prompted an HHS inspector general probe into the agency’s interactions with Biogen officials, which is ongoing.

Auchincloss, who now serves as executive vice president at consulting firm Greenleaf Health, said that Woodcock has “done an amazing job of trying to restore some credibility,” through public messaging on pandemic-related authorizations and approvals. But Auchincloss said there is more work to be done.

“It’s going to be a big job for the next confirmed commissioner to really bring the agency back around towards the science and build up their credibility again,” she said.

Real-World Evidence

Analysts say a new FDA head could also play a significant role in reaching the agency’s longstanding goal of data modernization, including by improving guidance on integrating real-world evidence in product approval applications.

The pandemic has forced U.S. health leaders to collect data outside of clinical trials, including from patient medical records and mobile devices, in order to make rapid decisions in the fight against Covid-19. Researchers have noted that a lack of clarity remains on how to ensure real-world data is in line with regulatory requirements.

“FDA during the Covid-19 crisis has changed a bit in some of the ways it’s doing business,” Howard Sklamberg, an FDA regulatory and policy attorney at Arnold & Porter, said. “It interacts with companies a little differently, it is more willing to take rolling submissions of data. Its communication style is different.”

A leader like Califf could help further push the FDA to develop more guidance on how to integrate new types of data, according to Sklamberg, who worked under Califf’s leadership as the FDA’s deputy commissioner for global regulatory operations.

Califf “is one of the world’s foremost experts on clinical trials and on the development of evidence for medical products,” Sklamberg said. “And he’s interested in making the evidence development process, both in terms of regular clinical trials and real world evidence, more efficient and quicker.”

Promoting Competition

Addressing rising drug costs is a priority of the Biden administration and Democratic lawmakers, and analysts say that, moving forward, the FDA could play an indirect role in driving down prices.

Even though the FDA “doesn’t really have a dominant role” in drug pricing, a new commissioner could help allow more cheaper alternatives to expensive brand-name biologics and prescription drugs, Sklamberg said.

Under Gottlieb’s leadership, the FDA announced the Drug Competition Action Plan to expedite review of generic drug applications to allow lower-cost options to enter the marketplace and drive down prices for consumers.

Analysts say that should Califf secure the nomination, he is likely to address practices among pharmaceutical companies that critics say have driven up prices. Califf co-authored an editorial piece in 2019 that advocates for “a sustainable, fair payment system in which drug prices reflect the value provided and reward innovations that improve outcomes.”

Preventing brand-name companies from filing patents solely to restrict competition, and ending manufacturer rebates to pharmacy benefit managers that negotiate drug prices, were among the changes recommended in the article published by the Journal of the American Medical Association.

Given the complex and varying responsibilities of an FDA commissioner, Sklamberg said that the process of nominating a candidate can be arduous. He added, though, that someone like Califf with prior experience leading the agency wouldn’t face the same learning curve that other candidates might have.

“You can devise policy, but to get the policy operationalized, you really have to know how it [FDA] works,” Sklamberg said. “Califf would not have to worry about that. He already knows the place quite well.”

To contact the reporter on this story: Celine Castronuovo at ccastronuovo@bloombergindustry.com

To contact the editor responsible for this story: Alexis Kramer at akramer@bloomberglaw.com, Melissa B. Robinson at mrobinson@bloomberglaw.com