Report: Departing FDA head Gottlieb looks back on his time at the agency ’ s head

Though he only held the position for just under two years, FDA Commissioner Dr. Scott Gottlieb said that he believes the agency’s scope has expanded significantly during his time at its head, according to a FierceBiotech report. The report comes from a fireside-style chat hosted by the Alliance for a Stronger FDA and the Pew Charitable Trusts in Washington, D.C., according to the report, at which Gottlieb spoke to a group including former FDA head Mark McClellan. “I think what’s changed most notably about the agency from the time I was there was that the scope has expanded so dramatically, in not a long period of time,” Gottlieb said, according to FierceBiotech. During his tenure, which began in May 2017, the FDA has expanded its framework to consider how to handle a number of new digital health products, significant advances in regenerative medicine and a changing healthcare landscape, according to the report. “These are dramatic expansions in the scope of the work that we do. It’s really changed the contours of the agency’s mission, and has made it far more diverse and vast. We actually had to conceive of different ways of regulating,” Gottlieb said, according to FierceBiotech. Gottlieb also touted that the agency has approved a record number of new drugs under his guidance, reportedly apologizing to the attending former head McClellan for breaking his previously established record. When asked about the current debate over ris...
Source: Mass Device - Category: Medical Devices Authors: Tags: Featured Food & Drug Administration (FDA) Source Type: news