FDA: Having to do more with less
The New England Journal of Medicine has posted an article online about the travails of the Food and Drug Administration. The agency has been criticized for its role in the withdrawal of Vioxx from the marketplace and recent problems with contaminated Heparin from China.
But we ask the FDA to do a lot with not very much:
The fundamental problem is that legislators have heaped more and more responsibility on the FDA without appropriately increasing its budget. Between 1988 and 2007, additional FDA responsibilities were imposed by 137 specific statutes, 18 statutes of general applicability, and 14 executive orders. At the same time, the FDA received a 2007 federal appropriation of only $1.57 billion -- less than 75% of the budget for the school district in its home county in Maryland, and about the same as the projected cost of the infamous Alaskan "bridge to nowhere." The number of federally appropriated personnel authorized for the FDA has decreased from 9167 in 1994 to 7856 in 2007. And the remaining personnel must work with inadequate information technology: 80% of the FDA's computer servers are more than 5 years old; critical clinical trial records are stored on paper in warehouses, largely inaccessible for analysis; and the information technology budget is about 40% of that for the Centers for Disease Control and Prevention.
More money may not be the answer; the answer may be redefining and limiting the FDA's role. I don't know. But it is clear that to do its job as currently defined, the FDA lacks adequate resources. In particular, it doesn't have enough staff to inspect the foreign facilities from which 80% -- yes, you read that right -- of our drugs and drug ingredients now come. Under the current circumstances, additional problems similar to that of the Heparin from China might be not just likely but inevitable.
UPDATE: Americans' confidence in the FDA "has hit rock bottom."