What is at Stake for FDA in the Upcoming Elections, Part 2 – The House

J0384726_1 On the House side of things, there is greater potential for change than we noted on the Senate side.  First of all, everyone is up for re-election, not just one-third of the body.  Second of all, there are more committees that impact the FDA.  Third, it is here that it is more likely that a switch of leadership will occur and if it does, you can count on a spate of reform proposals and a good number of hearings and investigations.  Here are the Committees we need to look at:

  • Committee on Appropriations, Subcommittee on Agriculture, Rural Development, FDA, and Related Agencies – This first committee is about money, and will also face the challenges posed by a desire to increase the mandate of the FDA through reform and to meet the challenges posed by the recent IOM report.  A switch of the House to the Democratic side could mean a much more aggressive effort to expand budget to meet the IOM challenges, but only when connected with specific legislative proposals that will come from the Committee on Energy and Commerce, Subcommittee on Health. 
  • Committee on Energy and Commerce and Subcommittee on Health and the Subcommittee on Oversight and Investigations – real domestic health policy comes out of the Committee on Energy and Commerce and the Subcommittee on Health.  The current Ranking Member on the Subcommittee is Sharrod Brown, who is running for the Senate in Ohio.  When the Democrats were last in power in the House, this committee was chaired by Henry Waxman and it would make sense to look for that to happen again.  He also sits on the Subcommittee on Oversight and Investigations.  A switch in the House will bring provide him with a much larger voice in the policies proposed regarding the agency and the pharmaceutical industry.  He has recently introduced legislation to construct a legal pathway by which FDA could regulate follow-on biologics.  He is inclined to great levels of involvement into FDA decisions as evidenced by his recent request for an FDA investigation of decongestant efficacy.   While both of these subcommittees in the past produced large numbers of press releases on their activities, they have been largely silent for the past two years.  Look for that to change. 

What this means for the FDA is that a switch in the House creates new public affairs challenges for the agency and it is likely that the reputation, which has already sustained quite a bit self-inflicted damage as well as an erosion of regard by policy makers and the general public, is likely to be further challenged. 

That means that the agency should be preparing a public affairs plan that takes this scenario into account and incorporates it into its overall proactive communications planning.  Unfortunately, to date, there is little evidence that this sort of planning is something that is part of the culture given a track record that has been entirely reactive, and ineffective at that.  The agency would do well to have a post-election public affairs plan that is part of its overall communications plan for reputation rehabilitation. 

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