FDA Releases Draft Guide On Advisory Committee ‘Appearance Issues’

FDA released draft guidance to deal with “appearance issues” that make advisory committee members, even those who do not have financial interests and relationships that are conflicts of interest, appear to lack impartiality. FDA says if an appearance issue exists, the agency will then ask if the member’s participation outweighs the concern that a reasonable person may question the integrity of the agency’s programs and operations. Michael Ortwerth, FDA’s director of the Advisory Committee Oversight and Management Staff, said in...