AEI blames FDA for pipeline slowdown

Washington DC, USA-based think-tank the Americian Enterprise Institute has published a report analyzing the problems faced by the drug industry in the area of innov-ation, concluding that the opacity of the US Food and Drug Administration's regulation is a major contributor.

John Calfee, a resident scholar at the AEI, says in his report that the problems and those of the FDA are intimately related. For example, a major problem for the drug firms is to translate research in DNA-based and other biotech-nology-related applications into approvable treatments and diagnostics.

What is more, the AEI believes that pharmaceutical com-panies are intimited by the FDA into accepting obsolete or unnecessary regulations, because drug companies believe that they cannot afford to have a bad relationship with an over-arching regulator. Mr Calfee says: "firms do not feel free to publicly criticize FDA policies and especially, FDA decisions (and often avoid criticism even when speaking privately to FDA staff)."