Drugs

Hahn Should Tell Truth or Resign: Topol

FDA commissioner Stephen Hahn needs to hold a press conference and tell the truth about how he was pressured to misrepresent (see earlier story) the effectiveness of convalescent plasma or resign, according to widely acclaimed researcher and Scripps Research Translational Institute director Eric Topol. In an open letter to Hahn, Topol said this is his last chance for “saving any credibility and preserving trust in the FDA at this critical juncture amidst the pandemic.”

Topol’s letter calls for Hahn to explain how he “completely misrepresented the facts about convalescent plasma, and not hide this with the obscurity of technical terms such as relative and absolute differences. Tell us that you are capable and worthy of this pivotal leadership position and that you will not, under any condition, authorize a SARS-CoV-2 vaccine approval before the full Phase 3 completion and read-out of a program.”

The letter muses on the FDA institution’s eroding trust and Hahn’s ignorance of the agency’s mission statement, particularly “helping the public get the accurate, science-based information they need.” Topol says that since Hahn was sworn in 12/2019, he has “serially demonstrated a willingness to deviate from this bedrock premise. Immediately after president Trump widely and aggressively promoted hydroxychloroquine as a ‘miracle drug,’ on 3/30/2020, you granted an Emergency Use Authorization (EUA) for this drug without any sufficient or meaningful supportive evidence. Proof of that was borne out on 6/15/2020 when you revoked that EUA, acknowledging lack of efficacy and ‘ongoing serious cardiac adverse events and other potential serious side effects.’”

In an interview with CBS News, Hahn said a Covid-19 vaccine could be available by Election Day under an EUA. “I can tell you our decision at FDA will not be made on any other criteria than the science and data associated with these clinical trials,” he said. CBS News asked, “Would that promise go so far as to say that if you are pressured to make that kind of decision that you don't agree with, you would resign?” Hahn replied that “all options are on the table, with respect. I hope we won’t be in that position.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome