Drugs

FDA Probing Unauthorized Herpes Research

FDA reportedly has opened a criminal investigation into research by a Southern Illinois University professor who injected people with his unauthorized herpes vaccine. Kaiser Health News reports that professor William Halford, who died 6/2017, injected subjects with his experimental herpes vaccine in St. Kitts and Nevis in 2016 and in Illinois hotel rooms in 2013 without safety oversight that is routinely performed by FDA or an institutional review board.

The agency’s Office of Criminal Investigations reportedly is looking into whether anyone from the university or Halford’s former company, Rational Vaccines, violated FDA regulations by helping him conduct unauthorized research. The probe also is looking at anyone else outside the university or company who might have been complicit, the article says.

Kaiser says FDA rarely prosecutes research violations, usually choosing to administratively sanction or bar researchers or companies from future clinical trials. In this case, experts told the news service, human subject violations would be deemed especially serious given that Halford was not a medical doctor and had injected people with his experimental vaccine without any routine oversight.

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