FDA Commissioner - From Acting to Permanent?

The FDA is sorely in need of a permanent Commissioner who will stay in the job more than a year or two. The position has been a revolving door since David Kessler left in 1997. It's not likely the latest move will be the solution. Consider the following breaking news.

On March 15, the White House announced the nomination of Andrew von Eschenbach to be the permanent commissioner of the FDA. Von Eschenbach has been the acting head of FDA since former commissioner Lester Crawford resigned in September 2005. As acting head, von Eschenbach’s decision to keep his job as chief of the National Cancer Institute has raised criticism and conflict-of-interest concerns; if confirmed by the Senate he will have to leave the NCI.

This time the nomination process is mired in politics. Read the following statement issued within hours of the formal nomination.

"It is past time for the FDA to stop dragging its heels and make a decision on Plan B," Sen. Hillary Clinton (D-New York)wrote in a joint statement with Sen. Patty Murray (D-Washington). "We will place a hold on the nomination of Dr. von Eschenbach until the FDA issues a decision on Plan B, yes or no."

Plan B is the OTC morning-after contraceptive.

The hold means Von Eschenbach may never be confirmed by the Senate during Bush's term. "The FDA needs a full-time commissioner," said White House spokesman Ken Lisaius. "We hope the Senate gives the nominee timely consideration and provides him with an up-or-down vote."

Here's a brief summary of FDA's leadership since 1990.

• David Kessler 1990 - 1997
• Lester Crawford 1997 - 1999 Acting Commissioner
• Jane Henney 1999 - 2001 (2 years)
• Lester Crawford 2001 - 2002 Acting Commissioner
• Mark McClellan 2002 - 2004 (16 months)
• Lester Crawford 2004 - 2005 Acting Commissioner
• Lester Crawford July 2005 - Sept 2005 (2 1/2 months)
• Andrew von Eschenbach - Sept 2005 - Present Acting Commissioner, and still head of the National Cancer Institute
  

What does this mean for us?

Continuing confusion in dealing with FDA. The burden of proving that we are in control of our systems and processes has always fallen on industry, and it's in industry's best interest to be prepared to demonstate to FDA that our control systems work and we have confidence that we are operating our business in a state of control. This means being GMP compliant across the board.

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