WASHINGTON — At an employee town hall on Tuesday, Food and Drug Administration leaders tried to quell staff and external concerns about a controversial new program to fast-track certain drugs.
“This pilot is an effort to make our review processes patient-centric,” said Mallika Mundkur, deputy chief medical officer and leader of the new drug review program, according to a recording obtained by STAT. “Even getting a truly transformative therapy out to them a month earlier 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.” It has come under fire both internally and externally for allowing political officials to interfere with the drug review process, STAT previously reported.
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