This effort includes the development of guidances to provide greater clarity and transparency in the disclosure of waivers of relationships that could present the appearance of conflicts of interest, as well as additional efforts to implement more streamlined approaches that will improve the transparency in the appointment of members to the agency’s advisory committees.
It also includes working toward greater public dissemination of advisory committee schedules through increased mailings to public groups.
The FDA said that it is taking these steps to make sure that it continues to have rigorous approaches in place that enable it to continue to recruit advisory members through a process that places the quality of scientific input sought by the agency as a top criterion.
“The advisory committee process is integral to examining the intersection between medical practice and clinical research, to spark debate about it, and to subject scientific work to close public scrutiny,” said Dr Scott Gottlieb, the FDA’s deputy commissioner for medical and scientific affairs. “Some of the most valuable input often comes from people who are active practitioners but also heavily engaged in clinical research and we need to make sure that we continue to have the ability to recruit top clinical trialists.”