FDA veteran Pazdur warns that politics, ‘chaos’ are hurting agency

SAN FRANCISCO — Richard Pazdur, a veteran regulator at the Food and Drug Administration who left the agency last month, said Monday the firewall between political appointees and drug reviewers at the agency “has been breached,” and that there is not enough transparency around a new voucher program that grants accelerated review to certain drugs selected by Trump administration officials.

Pazdur said meetings about drugs in the voucher program should be open to the public or at least to the FDA staff, but “at the present time, it’s being held in a conference room that is adjacent to the commissioner’s personal office. There’s not enough room in that office even for the entire review staff that has worked on that application to attend this meeting.”

Most of the small group of people that meet to discuss the voucher drugs, if not all of them, directly report to FDA Commissioner Marty Makary, Pazdur said, and that’s “problematic.”