How Might Mid-term Elections Impact FDA and Pharma?

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Yesterday the Senate returned to Washington after recess and today the House returns.  Yes, they're baaaaack.

That means traffic and congestion has increased and a tidy 12 minute commute turns into a 45 minute snarl. Consider that a metaphor.

Today is also another primary day, with some important decisions being made in key states.  The election is less than two months away and one begins to ponder what might happen if there is a change in party leadership in the House and/or the Senate.  If you listen to pundits and even apply a very large grain of salt, a change in party leadership on the House side is certainly a possibility. Making no pretense to predict an outcome, one nevertheless wonders if there would be any meaningful impact for the FDA and the industry it regulates.

Will the FDA's agenda change?  That would be unlikely.  There would be the same drive I think that there has been, to restore the tattered image of the agency by returning to prior enforcement levels and vigilantly seeking to protect the health of the public in ever-increasingly proactive means.  And despite threats to roll back health care reform, the elements of reform that are being undertaken by the agency, such as the creation of a regulatory pathway for biosimilars, is unlikely to change.  

But, should there be a party switch, the new party in power will undoubtedly have its sights set on a new target – the White House in 2012.  And what will change for the FDA and other federal agencies is the role of oversight.

As responsibility for driving the agenda of oversight changes hands, it is likely that every move made by federal agencies, will be scrutinized for opportunities to criticize the Obama Administration, meaning increased investigations launched, letters of inquiry sent and hearings called.  Naturally, that includes the FDA.  The focus will likely be on the big, and the small.  That, in turn, will drive media coverage and consequently be shaping public opinion about the agency and the industry.  And this is one of those circumstances where the image of the FDA becomes closely linked with the industries it regulates.

As said, no predictions here.  But if there is a change in leadership, prepare for a change in tone and a consequential change in public perceptions.   

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