The Senate will soon begin the process of considering President Trump’s nomination of Dr. Scott Gottlieb, who has close professional and financial ties with the pharmaceutical and biotechnology industries, for commissioner of the Food and Drug Administration. A trial that began in a federal courtroom in Boston in January is a timely reminder of how the laissez-faire regulatory posture that Gottlieb is expected to promote can harm the public’s health.
The Boston trial involves the first of more than a dozen employees of New England Compounding Center (NECC) who distributed steroids contaminated with fungi. These caused infections that led to 64 deaths and more than 700 cases of illness or disability in 20 states in 2012 and 2013. The NECC employees now face charges that include fraud, murder, and violating federal laws. They exploited weaknesses in FDA oversight. The company essentially became a manufacturer of prescription medications without following the FDA’s requirements for manufacturers.
This article fails to address the biggest concern over Gottlieb, who works for venture capital firm NEA (New Enterprise Associates), who have pathologically funded startup medical device fraud which had cost taxpayers millions if not billions & patients their health if not lives. It’s like putting the fox in the hen house, killing patients faster.
NEA funded, in-part, Conceptus, now Bayer’s Essure, Gynecare, now Johnson & Johnson’s Gynecare or Women’s Health and Acclarent, where a fraudulent medical device was removed from the market. The acquiring company also Johnson & Johnson knowingly & willingly continued the fraud until the FCA forced the device off market, cost JNJ $18 million in civil damages and two former executives were convicted of selling a misbranded medical device and currently awaiting sentencing under Judge Allison Burroughs in Boston. NEA funded and profited from medical device fraud, leaving a trail of injured bodies without any accountability. Gottlieb is the last person taxpayers should want to head FDA.
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