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Bloomberg Law – Botched Covid Plasma Announcement Clouds FDA’s Vaccine Process

Bloomberg Law – Botched Covid Plasma Announcement Clouds FDA’s Vaccine Process

Overblown claims about antibodies harvested from infected Covid-19 patients’ blood threaten to undermine public faith in future FDA approvals of therapies or even vaccines.

The Food and Drug Administration will release additional information to support the recent emergency use authorization on convalescent plasma to treat Covid-19, Commissioner Stephen Hahn said Tuesday on “CBS This Morning.” Hahn has already walked back statements he made about the treatment’s efficacy during the White House conference after widespread criticism from scientists.

Convalescent plasma is the liquid part of blood harvested from Covid-19 patients that might contain antibodies to fight the infection. Clinical trials testing whether it is an effective treatment are ongoing.

The timing and handling of the announcement raised questions about political interference in FDA’s decision making. The Sunday announcement came one day before the Republican National Convention and one day after President Donald Trump suggested without evidence that the FDA may be delaying approvals as part of “deep state” opposition to his presidency.

Trump has also repeatedly suggested a coronavirus vaccine could be available by the end of the year. Any hint of political interference in that approval process could undermine public faith in the vaccination, public health experts warn. The FDA has said it won’t compromise scientific rigor and that a vaccine advisory panel will review the data in a public setting before any approval.

‘Saying the Right Things’

“They’re saying the right things that would give you comfort that the processes are going to be followed, and that a vaccine won’t be approved unless it really is safe and effective under FDA standards. But these actions certainly give me pause,” Kalah Auchincloss, senior vice president of regulatory compliance for Greenleaf Health and a former FDA deputy chief of staff, said in an interview. “There’s no good outcome if confidence in the FDA is undermined. It’s very bad.”

The Mayo Clinic, which was leading the convalescent plasma expanded access program that provided the therapy to more than 72,000 patients, recently submitted more data, Hahn said Tuesday.

“The professionals and the scientists at FDA independently made this decision, and I completely support them,” he said

The FDA’s emergency authorization will likely make the product far more accessible to patients than it has been, said Cathy L. Burgess, an attorney with Alston & Bird LLP, who will lead a session on emergency use authorizations at the Food and Drug Law Institute’s annual conference in October. With more data available in the future, FDA might update or even revoke the authorization as it did with hydroxychloroquine.

“Convalescent plasma is an inherently high risk product, with significant potential side effects, so it is not an ideal candidate for widespread use,” Burgess said. “Based on currently available data, however, FDA has determined that convalescent plasma ‘may be effective’ in treating COVID-19, and the benefits of its use outweigh the risks.”

‘Precious Public Confidence’

Hahn’s predecessor, Scott Gottlieb, defended the FDA’s decision scientifically but tweeted the public handling “will erode precious public confidence. You earn public confidence in small drops and you [lose] it in buckets.”

The FDA can ensure public trust with scientifically sound decisions, Auchincloss said. “But they really have to follow the science,” she said. “I imagine from having worked out there that the career officials are absolutely trying to do that, and I appreciate the non-political leadership there. They really are trying hard. But I think in this administrative climate, it’s hard.”

White House Chief of Staff Mark Meadows and several speakers at Monday’s Republican National Convention said the FDA needs to cut through red tape to make new treatments available faster.

“Speculating what the motivation is doesn’t really matter if people can just focus on what the actual data is,” said Jeff Allen, president and chief executive officer of Friends of Cancer Research, which has supported fast track programs for breakthrough therapies.

Over-promising a vaccine and speculating about politically motivated approvals are both harmful, he added.

“Those of us that have worked with the FDA extensively have complete faith that the people there will make the decisions based on the data. But we’re sort of setting up to undercut one way or the another by all of this speculation,” Allen said.

James A. Boiani, an attorney with Epstein Becker Green, said any vaccine that the FDA approves will be safe and reasonably effective.

“There will be judgment baked into the approval—like every approval—and some people will question whatever happens,” he said. “But I have confidence that FDA will make a reasonable decision. The stakes are too big for them as an agency, and as public health officials, to do anything else.”

Career scientists won’t stay silent if there’s an issue with the decision, Friends founder Ellen V. Sigal said.

“The leaders in public health both at the [National Institutes of Health] and the FDA are not going to allow something that will endanger the American public,” she said. “We may not have a perfect vaccine, but there will be transparency, there will be committees, there will be oversight, and there will be data that will be publicly available on it.…