In an interview with The Financial Times Sunday, the embattled FDA commissioner said he would be open to the agency green-lighting a vaccine against the SARS-CoV-2 virus before Phase III trials are complete. The agency also ousted its spokesperson, Emily Miller, after only 11 days on the job Saturday.
The FDA commissioner took to Twitter Monday night to defend his performance at the agency, which came under sharp criticism amid accusations that the authorization of a plasma treatment for Covid-19 was politically motivated and that he stood by while President Trump unfairly maligned FDA staffers, prompting calls for his resignation.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Over the weekend, Trump called the agency, without evidence, part of a "deep state" that was slow-walking vaccines and drugs for Covid-19. The next day, the agency authorized convalescent plasma despite having turned it down shortly before due to insufficient evidence.
Amid fears of a premature emergency use authorization for a Covid-19 vaccine granted for political reasons, the guidance that the FDA released at the beginning of the month sets much tougher standards. But trial enrollment, anti-vaccine sentiment and other potential problems persist.
The agency issued a guidance for industry laying out its various recommendations for vaccine development. The announcement preceded the release of data from Pfizer and BioNTech's Phase I/II clinical trial of their messenger RNA vaccine.
While not necessarily faulting the FDA for granting a limited emergency use authorization to hydroxychloroquine and chloroquine despite little data to support their use in the pandemic disease, some interviewed experts said it risked politicizing the agency.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
In remarks at the daily Coronavirus Task Force press briefing, FDA Commissioner Stephen Hahn pointed out that the drug, remdesivir, is available under compassionate use in addition to the ongoing clinical trials being run by Gilead Sciences and the NIH.
The Senate voted 72-18 Thursday to confirm Hahn, a radiation oncologist and chief medical executive at The University of Texas MD Anderson Cancer Center.
HHS announced that it had nominated Dr. Stephen Hahn as the next FDA commissioner. Acting Commissioner Ned Sharpless will return to the National Cancer Institute, while HHS official Brett Giroir will temporarily step in pending Hahn's confirmation.
Dr. Stephen Hahn, a radiation oncologist and MD Anderson's chief medical executive, has reportedly been in the running since September to succeed former FDA Commissioner Scott Gottlieb and current acting commissioner Ned Sharpless.
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BioCentury reported that the the nomination of radiation oncologist Dr. Stephen Hahn, who had been under consideration, would follow an FBI background check. Acting Commissioner Ned Sharpless and Brett Giroir, an assistant HHS secretary, had also reportedly been in the running.
Trump is reportedly considering Dr. Stephen Hahn to head the FDA. Others reportedly under consideration include acting Commissioner Ned Sharpless and HHS assistant secretary Brett Giroir.