FDA Matters Blog
Register to get regular updates from FDA Matters FDA Matters Home


FDA After the Election—Part 2: Leadership and Change

Apart from an occasional reference, FDA is not part of the campaign dialogue leading up to the November 6 nationwide U.S. election. Yet, FDA Matters believes that FDA will be strongly impacted by the election’s outcomes.  Part 1 of “FDA After the Election” concentrated on the agency’s budget situation.

Part 2 of “FDA After the Election” focuses on leadership and change–directly and as they may be affected by potentially large budget cuts. There are some predictable elements, but other elements with great impact may depend upon the perspective of those in power for the next two years and beyond.

Drivers of Change, Post-Election.  Whether President Obama is re-elected or Governor Romney becomes President-elect, FDA’s primary responsibilities remain roughly the same: to be the guardian of food, drug and device safety and to provide a reasonable and responsible pathway for pre-market review of drugs and devices. Likewise, no President has the power to alter the main drivers of FDA’s increasing workload: globalization, scientific complexity, growing regulated industries and new legislative and regulatory mandates in food safety, drugs and devices.

Historically, change at FDA is affected by:  

  • the interest level of the President (most Presidents aren’t interested in FDA),
  • a growing or shrinking agency budget  (budget cutbacks distract, reduce options),
  • an acting vs. a confirmed Commissioner (“acting’s” tend to be placeholders),  and
  • the political will of Congress (legislation, oversight/investigations, or indifference).

If President Obama is Re-elected….then the two main drivers of change are likely to be whether Commissioner Hamburg decides to stay and the federal budget situation.  

This chart explores the variables and draws some conclusions about the opportunities for change. Not surprisingly, they are greatest if Dr. Hamburg stays and there is no sequester. The worst case would be a sequester and a long-term “acting” commissioner; it is only a slight exaggeration to suggest the agency would be set adrift and some panic might set in.

President

Commissioner

Most like what prior situation?

Budget Status

Opportunities for change

 

 

 

 

 

Obama Year 5

Hamburg

Kessler 1993-1994

No sequester

Change continues

Sequester

Orderly retreat?

 

New nominee

Von Eschenbach    2006-08

No sequester

Orderly transition: some change

Sequester

Disorderly retreat?

 

“Acting” for >  than 6 months

Crawford 2004-05

No sequester

Orderly transition: few changes

Sequester

Agency set adrift?

 

If Governor Romney is Elected…..then the main drivers of change are likely to be his interest level (his plate is likely to be full elsewhere), how quickly he nominates a new commissioner, how controversial his nominee is, and the federal budget situation.

This chart (as the one above) explores the variables and draws some conclusions about the opportunities for change. The best situation would be a well-known, well-respected, candidate who could win easy confirmation. That person would have the opportunity to make a lot of changes—although there would be notable differences if a new commissioner faces budget cuts. The worst case for change would be a replay of 2001-2002, when President Bush allowed more than 18 months to go by without a commissioner in place.

President

Commissioner

Most like what prior situation?

Budget Status

Opportunities for change

 

 

 

 

 

Romney Year 1

New nominee easy to confirm

Hamburg  2009-2010

No sequester

Time to shake the place up

Sequester

Accelerates shake-up?

 

New nominee  hard confirmation (not “acting”)

None?

No sequester

Congressional constraints in exchange for confirmation?

Sequester

How long is someone acting?

 

“Acting” for >  than 6 months

2001-2002

No sequester

Confusion: who to serve?

Sequester

Panic in the streets?

 

Timeframes.  While the charts provide a more comprehensive overview of the prospects for leadership and change at FDA, the scenarios will actually unfold over a period of months. Presumably, we will know who will be President within a day or two of the election. However, sequester (or other budget cuts) are not likely to be determined until later this year or may be delayed into next year.

Whether Dr. Hamburg stays will be both her decision and that of President Obama. That might be announced quickly or not.  If there is to be a Romney Administration, it is likely to be at least March 2013 (more likely later) before a nominee is announced.

Steven

Leave a Reply

You must be logged in to post a comment.

© 2009-2012 by HPS Group. All rights reserved. Permission is hereby granted to those wishing to quote or reprint from this site, providing it is properly attributed to FDA Matters: The Grossman FDA Report™.