Strife At FDA: Second Trump Appointee Ousted Amid Squabble With HHS
John “Wolf” Wagner is out as the head of FDA's office of external affairs. Politico reports that two high-level staffing changes and a public relations consultant's termination at HHS are part of a "tit for tat" battle between FDA chief Steven Hahn and HHS Secretary Alex Azar related to the botched convalescent plasma announcement. Meanwhile, KHN reports on hospitals defying FDA on that issue.
AP:
Second Trump Appointee Out At FDA Amid Credibility Concerns
A second Trump administration appointee has been ousted at the Food and Drug Administration in the wake of the agency’s botched announcement about an experimental therapy for COVID-19, which medical experts said damaged the health regulator’s credibility with the public. An FDA spokesperson confirmed Wednesday that John “Wolf” Wagner, a political appointee installed by the White House earlier this summer, is no longer heading the agency’s office of external affairs. Instead, Heidi Rebello, a longtime FDA career official, has stepped into the position on an acting basis, overseeing all FDA public communications. Politico first reported the news. (Perrone and Foley, 9/2)
Politico:
Hahn, HHS In ‘Tit For Tat’ Feud Over Covid-19 Messaging
The dispute over whether to allow the use of blood plasma treatments for coronavirus on an emergency basis has set off what one senior official described as a “tit for tat” battle between Food and Drug Administration Commissioner Stephen Hahn and the leadership of the Department of Health and Human Services, with each side engineering the replacement of communications aides installed by the other. HHS Secretary Alex Azar was furious when Hahn openly backtracked on claims about plasma’s effectiveness, at a time when President Donald Trump was preparing to tout the treatment at the Republican National Convention. Hahn, for his part, sought to apologize for data that overstated the treatment’s benefits and felt that his department’s promotion of the treatment as “another achievement in [the] administration’s fight” against Covid-19 smacked of politics at a time when the agency is trying to preserve its scientific integrity, said five people with knowledge of the internal deliberations. (Diamond and Owermohle, 9/2)
Kaiser Health News:
Dozens Of U.S. Hospitals Poised To Defy FDA’s Directive On COVID Plasma
Dozens of major hospitals across the U.S. are grappling with whether to ignore a federal decision allowing broader emergency use of blood plasma from recovered COVID patients to treat the disease in favor of dedicating their resources to a gold-standard clinical trial that could help settle the science for good. As many as 45 hospitals from coast to coast have expressed interest in collaborating on a randomized, controlled clinical trial sponsored by Vanderbilt University Medical Center, said principal investigator Dr. Todd Rice. (Aleccia, 9/3)
In other news about the government's response to the pandemic —
The Wall Street Journal:
White House To Target Hospitals For Uneven Covid-19 Data Reporting
The Trump administration is taking aim at hospitals, charging that many have been contributing uneven data about Covid-19 cases in the federal effort to gauge the pandemic. In a move expected as early as next week, the administration is planning to publicize the names of hospitals with data missing from the federal pandemic reporting system, according to people familiar with the discussions. It’s the latest move by federal officials to target hospitals for gaps in daily tallies of Covid-19 patients, shortages of nurses, the number of available beds and other data. Making data gaps public will let those who use the data see its holes and put hospitals on alert that they risk losing payment from Medicare and Medicaid, the publicly subsidized health insurance programs, under a rule soon to take effect, the administration told industry officials Tuesday, people familiar with the discussions said. (Evans and Berzon, 9/2)
Stat:
Biotech Leaders Call For Covid-19 Data Transparency, FDA Independence
A group of prominent biotech CEOs are calling on their peers and the federal government to hold themselves to the highest standards when it comes to developing and reviewing Covid-19 treatments. Among their demands: That biotech companies don’t simply release clinical trial data in press releases, and that federal regulators make it clear to the public that any vaccines or treatments will be approved strictly based on science. (Florko, 9/3)
