Drugs

Hahn Removes New Press Head After Controversial Remarks

FDA commissioner Stephen Hahn has removed newly appointed chief spokeswoman Emily Miller in the wake of his controversial remarks exaggerating the efficacy of convalescent plasma for Covid-19 he made at an 8/23 White House press conference. Miller was installed at FDA by the White House less than two weeks ago and she immediately began drawing attention after the press conference (see earlier story), including her limited understanding of science and health issues. She is a former reporter for right-wing cable network One America News and a huge supporter of president Trump. No reason was given for Miller’s removal and Hahn says he will soon name an interim replacement.

In what HHS describes as a coincidence, public relations consultant and former FDA associate commissioner for public affairs Wayne Pines had his consulting contract with the Department abruptly terminated. Pines had advised Hahn to correct misleading comments about the benefits of blood plasma for Covid-19, according to a New York Times report. “I did recommend that he correct the record,” Pines said, adding that he wasn’t told why his contract was severed. “If a federal official doesn’t say something right, and chooses to clarify and say that the criticism is justified, that’s refreshing,” he said.

Pines currently is president of APCO Worldwide, a public relations and lobbying firm that represents health companies that do business before the agency. Pines told the Times that his HHS consulting gig was on his own time and outside APCO’s practice, noting that as a friend he is willing to continue advising Hahn for free.

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