Woodcock, Marks Recusals From COVID-19 Product Reviews 'Protect FDA's Reputation'

Companies developing COVID-19 related products will no longer be able to turn to Janet Woodcock and Peter Marks – the respective directors of the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research – to get their input on review matters. But FDA experts say this will not have a significant impact on reviews and is the right move to avoid the appearance of impropriety.

The two were given leading roles in the Trump Administration's Operation Warp Speed, an initiative to facilitate the development, manufacturing and distribution of COVID-19 vaccines, therapeutics and diagnostics that was announced on 15 May. Marks is to oversee the development of vaccines and Woodcock is to oversee the work on therapeutics. (Also see "Trump’s ‘Warp Speed’ Initiative Could Fund 3 to 5 Large-Scale COVID Vaccine Trials" - Pink Sheet, 17 May, 2020.)

FDA Commissioner Stephen Hahn noted the appointments in a 17 May email to FDA staff, saying Woodcock and Marks would continue as directors of their centers while working closely with other center and agency leadership to ensure continuity of day-to-day operations.

"They will also recuse themselves from the supervisory chain of command in matters related to product review decisions for applications related to the areas that they are advancing that have a nexus to COVID-19," Hahn stated.

Instead, CBER Deputy Director Celia Witten and CDER Deputy Director Patrizia Cavazzoni, respectively, "will be the responsible person in the supervisory chain for the review of applications related to the areas that have a nexus to COVID-19," an FDA spokesperson told the Pink Sheet. The change was made "in order to ensure that there are no perceived issues when we receive and review applications related to vaccines and therapeutics in this area."

Nancy Bradish Myers, president and founder of Catalyst Healthcare Consulting Inc., said that scientifically, the recusals make a lot of sense.

"Marks and Woodcock recognize they can't be both referee and player," Myers said. "The recusal is a step to protect the FDA's reputation so people see it as an unbiased and scientifically based organization."

She noted that Marks and Woodcock will have access to early data and make decisions on what candidates are likely to proceed and the regulatory strategy. "If they didn't recuse themselves it would leave FDA a target of questioning its impartiality," she said.

Deep Bench At FDA

As for the impact on product reviews, Myers said everyone knows it is a lean-in situation and is looking to do reviews carefully and as quickly as possible. "No one wants a situation where the validity of a vaccine that is approved is undermined by the view that it is a political approval," she said.

Marc Scheineson, co-chair of Alston & Bird's food and drug law practice and former FDA associate commissioner for legislative affairs, said the centers have a great bench of strength and depth and that there aren't many potential review issues that have to be resolved at the director's level.

He said getting Marks and Woodcock on the Warp Speed team was essential. "These are two very principled, very skilled, very experienced and talented government officials, the glue to what makes FDA great," he stated. "They won't be pressured into taking action."

Regulatory Community 'Reassured' By Appointments

While some have suggested that it is a conflict of interest for FDA officials to play a role in moving COVID-19 products forward, Scheineson dismissed this view.

"Do you want someone on deck who knows where they are going and has steered before" or do you want to leave it to volunteers who may be performing the tasks for the first time? he asked. "The FDA regulatory community is reassured" by having Marks and Woodcock on deck.

The situation is unusual, however. Myers said she could not remember a time when an agency official has taken on a government role during a national emergency and had to be recused from such a broad portfolio.

There have been instances in which FDA officials recused themselves from specific product reviews. Former FDA Commissioner Robert Califf recused himself from re-analysis of Johnson & Johnson's ROCKET-AF trial of Xarelto (rivaroxaban) because he had been involved in the study while he was at Duke University. (Also see "FDA Lifts Cloud Over J&J’s Xarelto With ROCKET-AF Re-Analysis" - Pink Sheet, 11 Oct, 2016.)

And former FDA Commissioner Scott Gottlieb had to recuse himself from FDA activities related to numerous companies for which he had served as a consultant or board member when he first returned to head the agency. (Also see "Gottlieb's Confirmation: Will Industry Ties Remain A Big Deal After The Hearing?" - Pink Sheet, 3 Apr, 2017.)