Monday, November 05, 2018

The Safety of the Public is not Important to the Commissioner

“I am very disappointed with the decision of the agency to approve the sufentanil sublingual tablet,” Brown said in a recent statement. “This action is inconsistent with the charter of the agency. [T]he lack of efficacy data and the sponsor’s inadequate response to safety concerns have not been addressed since the FDA’s complete response letter was sent in 2017. Clearly, the issue of the safety of the public is not important to the commissioner, despite his attempts to obfuscate and misdirect. I will continue to hold the agency accountable for their response to the worst public health problem since the 1918 influenza epidemic.”