FDA Policy/General

Keep Venture Capitalists Away from FDA: Whistleblower

Melayna Lokosky, a self-described corporate fraud expert and market analyst, who won a whistleblower case against Johnson & Johnson’s Acclarent unit, says that venture capitalists have no place running FDA. Writing in an online MedCity News opinion piece, Lokosky says that her experience is that “venture capitalists can fund startup medical device fraud. The last thing voting taxpaying citizens should want is anyone from venture capital anywhere near politics, much less FDA. Think about that. Venture capitalists now want to control FDA to speed up the medical device approval process. They want to make money off killing us faster with less regulation.”

She particularly takes aim at former FDAer Scott Gottlieb, whose name has been mentioned as a possible FDA commissioner. Lokosky says that Gottlieb is a general partner at New Enterprise Associates (NEA), which describes itself as the world’s largest venture capital firm. “NEA has pathologically funded startup medical device fraud that has harmed, killed, or defrauded taxpayers from Conceptus (now Bayer’s Essure), Gynecare (now a Johnson & Johnson subsidiary), and Acclarent (also a Johnson & Johnson subsidiary),” she writes. “Is that who we want to head the FDA?”

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