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Regulatory Focus – Former commissioners call on administration to end FDA criticism

Regulatory Focus – Former commissioners call on administration to end FDA criticism

Seven former commissioners of the US Food and Drug Administration (FDA) came together to call out the Trump administration for undercutting FDA’s credibility as the agency prepares to evaluate clinical trial data for vaccines against SARS-CoV-2, the virus causing the novel coronavirus pandemic.

Their comments, made in an opinion column published 29 September in The Washington Post, were welcomed by the FDA’s current vaccines chief, Peter Marks, MD, PhD, director of the Center for Biologics Evaluation and Research (CBER).

“I’m very grateful to you and the other FDA commissioners,” Marks said to co-author Mark McClellan, MD, PhD, at a virtual event hosted by the Friends of Cancer Research (FOCR).  “We need to come together as a scientific community…and have trust in the power of safe and effective vaccines.”

McClellan moderated a session with Marks and Janet Woodcock, MD, who is on leave from her FDA role to help lead the administration’s Operation Warp Speed. McClellan now directs the Duke-Margolis Center for Health Policy.

Criticism erodes public trust, say the former commissioners

The former commissioners focused their concern on the degradation of public trust in vaccines, and in federal oversight of medicine and food safety in general, that may occur when a politician tries to rest his thumb on the scale of scientific decision-making. They cited recent polls showing that almost half (42%) of Americans do not trust the FDA’s decision-making, and that over three-quarters (78%) worry that a vaccine approval will be too rushed.

Those concerns are unwarranted, according to the former officials. “Despite recent political actions, we continue to have confidence in the integrity and high-quality scientific work of FDA staff,” they wrote, noting that vaccine trials are ongoing with independent oversight by data safety monitoring boards. “The FDA has already effectively communicated its strict standard for evidence from these trials to the manufacturers, despite comments from the White House.”

Marks concurred in his FOCR comments. “The bottom line is that we’re going to do our job to make sure we do the right benefit-risk calculations” in weighing approvals and authorizations for vaccines against COVID-19, he said. “We’re paid to be cautious…but we also have to balance the fact that removing every last doubt possible could also lead to loss of life if we require the bar to be so high” that no adverse events are tolerated, he noted.

Whither vaccine EUA guidance?

McClellan asked about the status of a draft guidance on emergency use authorization (EUA) for a COVID-19 vaccine, which is reported to be awaiting administration approval. Marks, referring to the draft document in the past tense, said, “This guidance was an attempt to get as close as we could to what we would see” for a full vaccine approval. “The guidance was trying to explain that and to reassure the public that we are going to have a transparent advisory committee meeting for each and every vaccine that comes through.”

With or without the guidance, said Marks, “Before there’s an FDA decision, there will be a meeting with the independent advisory committee, with the chance for FDA to comment in writing on everything” that’s included in the submission. “It may not make the most exciting TV watching,” he said, “but we intend to webcast it.”

Marks nodded vigorously when McClellan asked whether FDA’s goal is to have any vaccine EUA submissions come “as close as possible” to the standards required for a full approval. Marks also pointed out that a typical patient database for a vaccine approval under a biological license application (BLA) could range from 80,000 to 160,000 person-years of follow-up. For a COVID-19 vaccine EUA, he said he would expect to see a quarter to half that number of patient-years in a database. However, he said, surveillance systems have improved markedly over the last few years, and he expects any post-EUA safety signals to be picked up in that fashion: “These are really systems that can help us.”

An update from the Presidential debate – and a gut check from Moderna

On the same night as the FOCR reception, during the first debate between President Donald Trump and former Vice President Joe Biden, the president said, “I spoke to the scientists in charge. They will have the vaccine very soon.”

Trump also said that both CDC Director Robert Redfield, MD, and Moncef Slaoui, PhD, the pharmaceutical executive who left his GSK post to head Operation Warp Speed, were wrong in forecasting that a coronavirus vaccine would not be generally available until the summer of 2021.  “I’ve spoken to the companies, and they said we could have it a lot sooner,” Trump said. “it’s a political thing. People like this would rather make it political than save lives.”

However, the sponsor of at least one leading vaccine candidate is signaling a timeline that pushes into 2021. The Financial Times (FT) reported that Moderna’s chief executive Stéphane Bancel set a 25 November 2020 date for when their clinical trial will have accrued enough safety data to file for an EUA, with a likely January 2021 filing date for BLA approval.

“I think a late [first quarter], early [second quarter] approval, is a reasonable timeline, based on what we know from our vaccine,” Bancel said at FT’s US Pharma and Biotech Conference.

“Drug makers,” the former commissioners pointed out in their opinion piece, “have also pledged to use the FDA’s scientific standards. But the perception of political influence matters. Political intrusion only prolongs the pandemic and erodes our public health institutions.”

The Washington Post opinion piece was written by former FDA Commissioners Robert Califf, MD; Scott Gottlieb, MD; Margaret Hamburg, MD; Jane Henney, MD; David Kessler, MD; McClellan; and Andy von Eschenbach, MD.  The Post reports that Kessler is an adviser for the Biden campaign, and that Gottlieb and McClellan, respectively, serve on the boards of two companies that are developing COVID-19 vaccines, Pfizer and Johnson & Johnson.…