The Association of Clinical Research Organizations (ACRO) released its statement addressing the nomination yesterday, in which it said it “applauds the thoughtful nomination of Dr. Gottlieb as FDA Commissioner.”
Scott Gottlieb is a physician, a resident fellow at the American Enterprise Institute, and a venture partner at New Enterprise Associates. In 2005, he was appointed as the Deputy Commissioner for Medical and Scientific Affairs at the US FDA.
While this experience made him the top choice for many in the industry, others are wary of his connections – namely payments from several big pharma companies – the likes of which include GlaxoSmithKline, Daiichi Sankyo, and Valeant Pharmaceuticals.
However, ACRO’s Senior Vice President, Policy and Public Affairs, John Lewis, told us “Scott clearly appreciates and understands the complexities of drug development.”
“We would expect him to be a strong partner for patients, researchers, and industry in supporting innovative approaches to clinical trials, including the use of new drug development tools,” he said.
Notably, Lewis told us ACRO “especially looks forward to working with him and his team at FDA on implementation of the 21st Century Cures Act.”
As Outsourcing-Pharma.com previously reported, ACRO and other industry recently penned a letter to the National Institute of Health in which it the government organization to adhere to 21st century deadlines that if missed, would affect improvements to ClinicalTrials.gov.
NIH has since responded, pledging its commitment to enhancing the usability of ClinicalTrials.gov.
“Industry, regulators and patients must work together to find ways to improve the efficiency of the clinical trials process and shorten the development timeline without sacrificing patient safety or efficacy,” Lewis concluded.