The Election is Over – Is There an FDA Impact?

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Probably.

As the results from yesterday's election are digested by various parts of the nation, for those of us with an eye on FDA, one has to wonder if there is any direct impact on the future of the agency and on the many industries it regulates as a result of the seismic shift in representation, particularly in the House of Representatives.

On the most general front, there is this.  The mantra of many who have been newly elected is focused on "less government" and "deficit reduction".  Less government means smaller government.  It also means less enforcement.  

During the Bush 2 Years, enforcement, as noted many times here, expressed through the issuance of regulatory action letters respecting advertising and communications declined significantly and only in the past few years has it begun to again increase ever so slightly upward again.  And, as we have seen since Drs. Hamburg and Sharfstein have taken the helm at FDA, there has been a repeated intention to restore the FDA as a premiere guardian of public health.  

In fact, as any FDA-watcher can tell you, there has been a great deal of activity on the part of the agency, from expanding its own transparency to putting into place new and tighter parameters of safety on both food and drugs.  

So what does "less government" mean?  Generally might it mean a  return to the 2000s?  

And now that a chunk of FDA oversight will be chaired by Congressman Darryl Issa (R-CA), who during the 2007 Avandia congressional hearings was quoted in the New York Times questioning whether the scrutiny of the safety of the drug was a "political concoction to anecdotally go after a company" and he stated that he objected to it.  In 2010, you will remember, Avandia use was severely curtailed by FDA in the U.S. and withdrawn completely in other parts of the world. Will "less government" signal a new ere whereby FDA will have to walk more softly when investigating the safety of a drug or will the agency have to resolve itself to sharp scrutiny in doing so?

There are man other aspects of the election that will impact FDA, some of which may include funding for new initiatives at a time when FDA has repeatedly signaled the need for increased funding in order to pursue safety efforts, particularly as globalization has increasingly challenged the ability of the agency to oversee the production chain of both food and drugs.  

It will take a while for the dust to settle, but it certainly stands to reason that it is going to settle in a different place.   

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