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  • STAT News, Renee M. Landers

Scott Gottlieb’s fervor for deregulation could harm patients

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.

As the tragic consequences of the NECC episode fade from our collective memory, the Trump administration’s overall deregulatory orientation, deregulatory provisions in newly enacted and proposed laws, and corporate-friendly judicial doctrine constitute a prescription for future public health crises. In this context, Gottlieb’s documented advocacy for deregulation is particularly troubling. In addition, his close ties to industry may pose untenable conflicts of interest requiring him to recuse himself from many important FDA decisions.

Just six weeks before Trump took the oath of office, President Obama and Congress enacted the 21st Century Cures Act. This law promises to increase federal funding for research and for pressing public health concerns like the opioid addiction epidemic, but at the same time it reduces the evidence required for FDA approval of new drugs and devices.

Read the original article here.

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