The former Commissioner of the US Food and Drug Administration (FDA), Andrew von Eschenbach, said in a Wall Street Journal op-ed he believes a shortage of resources at FDA is behind a proliferation of regulatory uncertainty and a lack of innovative approvals.
"[Breakthrough technologies] have been stalled by regulatory uncertainty, because the FDA doesn't have the scientific tools and resources to review complex innovations more expeditiously and pioneer regulatory pathways for state-of-the-art therapies that defy current agency conventions," wrote Eschenbach in his 15 April op-ed.
The problem, explains Eschenbach, doesn't lie with "mean-spirited or foolish" FDA staff, but rather with Congress.
"[F]or decades, Congress has starved the agency of critical funding, limiting its scientists' ability to keep up with peers in private industry and academia," writes Eschenbach. "The result is an agency in which science-based regulation often lags far behind scientific discovery."
In order to get around this lack of funding while still ensuring the safety and efficacy of products, FDA's staff need to call "time out" or otherwise delay therapies while its staff works to evaluate therapies.
The lack of funding also hurts ongoing training opportunities for FDA staff, remarks Eschenbach.
"I was surprised to learn there are no provisions for continuous education to acquire new skills in emerging fields such as stem-cell biology, nanotechnology or computational biology," writes Eschenbach of when he joined the agency as Commissioner. "Even sending agency staff to academic conferences provoked a congressional outcry over meeting and travel costs."
"Fortunately, Congress may have an opportunity as soon as this week to begin changing" FDA's funding situation, notes Eschenbach.
The Senate Committee on Appropriations is scheduled to meet 19 April for a hearing to review the 2013 budget request for FDA. Speaking at that hearing will be FDA Commissioner Dr. Margaret Hamburg and Assistant Commissioner for Budget Patrick McGarey.
Senate Committee on Appropriations - Hearing to Review the 2013 Budget Request for FDA
Wall Street Journal - Andrew von Eschenbach: Toward a 21st-Century FDA (Subscription)