What is at Stake for FDA in the Upcoming Elections, Part 1 – The Senate

J0384726Congress is thankfully leaving our town to come to your’s and, for most, to seek re-election.  Amazingly, they are asking for that despite the fact that they have not even reached 100 days in session, making them the least active Congress ever.

But one-third of the Senate, and all of the House of Representatives have cut out to spend a good quantity of the money they raised to get your vote so that they can come back here for another round.  There is a lot at stake in the upcoming elections and as one can see in the column to the right, there are a number of legislative proposals that directly impact both the agency and the pharmaceutical industry. 

Therefore, it seems like a good time to look this week at what’s at stake for the FDA ans what could change should, as many are speculating, either or both the House or the Senate could switch from Republican control to Democratic.

Today, we will focus only on the Senate.  While this will be a new Congress and committee assignments will change, many will not.  These are the committees that have oversight over the FDA:

  • Committee on Appropriations, Subcommittee on Agriculture, Rural Development, and Related Agencies – This committee is not about policy, but money.  Particularly at a time when there is increasing demand for a broader mandate for FDA, money for FDA operations is going to be a key factor.  However, there is not as much in flux as there is with the Committee on Health Education, Labor and Pensions.  Only three senators are up for election from this committee – Dianne Feinstein (D-CA), Herb Kohl (D-Wisc) and Conrad Burns (R-Mont) – of these, only Burns is in question. 
  • Committee on Health, Education, Labor and Pensions – The Republicans on this Committee who are up for re-election include Orin Hatch (Utah), John Ensign  (Nevada), and Mike DeWine (Ohio).  One Republican member, Bill Frist (Tennessee) will not be running for re-election and is one of the four seats in the Senate that are up for grabs with no incumbent.  On the Democratic side, there are three members up for re-election, Jeff Bingaman (New Mexico) and Hillary Clinton (New York) and Edward Kennedy (Massachusetts), all of whom are secure in their re-election.  However, on the Republican side, Bill Frist is disappearing and Mike DeWine is facing a tough challenge in a tough state from Sherrod Brown.  Should Brown win that election, this committee is a likely place for him to land and given his active criticism of the agency and the industry, he is likely to be hawkish on reform, even if the Democrats remain in the minority.  If there is a switch however, there is a good possibility that Senator Kennedy could take the chair and a very high likelihood of reform-minded legislation moving. 

A lot of the folks up for re-election on the Democratic side are co-sponsors of Senator Dorgan’s bill to allow the importation of drugs.  Senator Herb Kohl (D-Wisc) also up for re-election is the sponsor of a bill that would prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, though none of the co-sponsors are up and he would not appear to be going anywhere. 

Should there be a switch in the Senate, Jim DeMint’s bill to force FDA to pull RU-486 – a bill that has gone nowhere – will continue its course.  But the pace and intensity of reform legislation is likely to pick up. 

Later this week, we’ll explore how the House side of things stack up. 

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