Leaving PDUFA Alone

PDUFA IV, as has been noted here many times, is up for passage in the Congress.  For those new to it, PDUFA is the Prescription Drug Users Fee Act which, if authorized, will provide a majority of funding for FDA enforcement activities.  Many decry that situation, but also as noted here before, user fees are employed by many agencies across government and the European Medicines Agency (EMEA) also is heavily underwritten by such fees.

Recently,  House Committee on Energy and Commerce Chairman John Dingell (D-Mich.) and Frank Pallone (D-N.J.) sent an inquiry to FDA Commissioner Andrew C. von Eschenbach asking what the timeframe would be for FDA to have to begin workforce reductions without PDUFA funding.   The rationale, according to FDA News, is to better understand the time frame for the Congress to have to do its work.

There is a lot of FDA-related legislation that has been proposed in the 110th Congress, as those visiting the blog site can see off to the column at the right (those who subscribe by email or RSS feed will have to visit the site to see it).  It is sometimes been rumored that there may be attempts on the part of some to attach these pieces of legislation to the PDUFA legislation as an add-on.

Such a move is ill-advised.  Patients are reliant on the FDA to consider new medicines and get them approved quickly – that is why PDUFA was conceived in the first place.  The fact that PDUFA fees among some quarters are controversial and perceived as undercutting the agency’s objectivity, makes it essential that this legislation be considered on its own, unencumbered by other contentious proposals.   PDUFA IV, which I support in spite of unanswered questions on its implementation from FDA, deserves consideration on its own and patients whose lives are hanging in the balance deserve nothing less. 

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