White House memo sends research advocates into a panic

The Trump administration is going to start reviewing all agency guidances the way it currently reviews regulations (read: much more slowly) — and FDA insiders are freaking out.

The FDA in particular tends to operate via guidance rather than via regulation, since the agency can put out those memos much more quickly than formal rules. Recently departed FDA Commissioner Scott Gottlieb released more than 400 during his two-year tenure.

The potential slowdown at the FDA “terrifies” Ellen Sigal, the chair of Friends of Cancer Research, a nonprofit that works closely with the FDA on developing guidance for cancer drug development.

“This will stop everything in its tracks,” Sigal told STAT. “It will hurt patients and it will accomplish nothing.”

I’d be shocked if Sigal is the only well-known FDA advocate to publicly clash with the new policy. Keep an eye out here to see if the FDA eventually gets carved out from the policy, which is set to take effect May 11.