Sharpless Wants to be Nominated for Commissioner
FDA acting commissioner Ned Sharpless told the Washington Post 6/19 (see transcript) that he would like to be nominated by President Trump as the next agency commissioner. “The FDA is a wonderful, marvelous place,” he said. “The people are these cutting-edge scientists with this great passion and sense of regulatory mission. So, I think, you know, be a great place to be involved with, but that decision of who runs the FDA is really up to the White House.”
Whomever the Trump Administration chooses, Sharpless said it needs to be someone with a strong voice in charge of it. There are a number of problems FDA has to face, such as with the media, government, and hiring and retention, he explained. “And so, a confirmed commissioner, in many ways, would be good for the FDA,” he said. “I think a long period of acting would not be good for the agency.”
Asked how he intends to leave his mark on FDA, Sharpless said he believes it is important to develop the workforce — “staffing the right people to regulate these very innovative new products that we have is a real challenge to the FDA.” He said he does not expect a tremendous shift from the agenda developed by previous commissioner Scott Gottlieb, who left the agency two weeks ago. “We agreed on a number of things,” Sharpless told the Post. “But you know, the facts on the ground change and there are areas where things have to be done — you know, we have to change our thinking and change and do mid-course corrections. So, you know, there'll be some of that.”
As a proponent of improving the clinical trial process, Sharpless was asked if he is satisfied with clinical trials at this point? He said that the days of two large randomized trials showing an overall survival advantage are no longer appropriate in cancer, for most patients. “I think we should be very comfortable using other end points and other trial designs, and even, you know, data from the real world... And I think the FDA has been very aggressive about adopting that, particularly in cancer, but in other disease types, as well.”
Sharpless said that as product development approaches become more and more precision-based, the groups of patients become smaller and performing large, randomized trials becomes more and more difficult. “And therefore, I think novel clinical trials design is going to be really important for both the research effort, like at the NIH, and then also the regulatory effort at the FDA,” he said.