STAT+: Official: FDA needs staff influx to meet gene therapy needs

WASHINGTON — The Food and Drug Administration needs dozens more reviewers if it wants its so-called Operation Warp Speed for rare disease therapies to take off, the agency’s biologics chief said Monday.

The administration launched the rare disease pilot program, dubbed START and modeled after the record race for a Covid-19 vaccine, this September. Peter Marks, head of the Center for Biologics Evaluation and Research, has spearheaded both initiatives.

“If we were really to expand this significantly, [it] would require us to get dozens of additional staff members,” Marks told listeners during a gene therapy discussion hosted by the Alliance for a Stronger FDA. “One could say oh my goodness, he’s asking for more headcount again. Well, if this really does reduce the time to development by 25 to 50% … it probably won’t take industry too long to do a net present value calculation to say ‘Oh, it’s worth making sure that they have their extra 20 or 30 or 40 reviewers.”

Continue to STAT+ to read the full story…

Read Original Article: STAT+: Official: FDA needs staff influx to meet gene therapy needs »