Marty Makary addresses staff concerns about drug voucher program

WASHINGTON — At an employee-led town hall Tuesday, Food and Drug Administration leaders tried to assuage concerns from within and outside staff about a controversial new program aimed at fast-tracking certain drugs.

“This pilot is an effort to make our review processes patient-centered,” said Mallika Mundkur, deputy chief medical officer and manager of the new drug review program, according to a recording obtained by STAT. “Even offering them a truly transformative therapy a month early could potentially lead to decades of life for that patient.”

The program, called The Commissioner’s National Priority Voucher, launched in June and allows the FDA to grant one- to two-month reviews to companies that prove their drugs “align with national priorities.” He has been criticized both internally and externally for allowing politicians to interfere with the drug review process, STAT previously reported.