FDA is in crisis, experts say

The Food and Drug Administration’s ability to protect the public from unsafe drugs and medical devices has radically deteriorated, expert witnesses told a congressional committee on Tuesday, January 29. “Without urgent action,” Gail Cassell, an Eli Lilly vice president and head of an internal FDA scientific advisory board, testified, “injury and death are certain.”

Garret FitzGerald, a professor at the University of Pennsylvania School of Medicine and member of the science board, said the problems are systemic and include depleted infrastructure; critical gaps in science expertise; erosion of financial resources; inadequate information technology; poor morale; and an inability to enforce its own rules.

“The FDA is in crisis. The ability of the agency to fulfill its mandate has eroded to a critical degree,” FitzGerald said.

FDA’s health dire, experts say [Via The (Trenton, NJ) Times]

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