Long-term lack of stability at US FDA

Since the 1988 Health Omnibus Program Extension has made the appointment of the US Food and Drug Administration's Commissioner the subject of a  Senate confirmation process, the agency has suffered from temporary  management.

John Calfee, a health care expert at a conservative-oriented think-tank,  the American Enterprise Institute, notes that since the resignation of  the first FDA Commissioner to undergo senatorial scrutiny, David Kessler  in February 1997, more than half of the period since has seen the  federal regulator under the control of an interim leader. "The four  interim periods without a confirmed Commissioner averaged 18.5 months  and none has been shorter than 15 months," Dr Calfee writes in the  American.com, the AEI's on-line magazine.

One harmful effect of this procedure, the AEI resident scholar argues,  is that "watchful critics in Congress, academia and the practitioner  community are quicker to spot something amiss with an FDA-approved  product than they are to discern slowness or inefficiency in moving  development and approval [for pharmaceutical agents] forward." He adds  that "one-sided criticism," often vitriolic, "is bound to push the FDA  staff toward over-caution."