Life-saving drugs and deadly delays

The Food and Drug Administration just granted permission for “expanded access” to an experimental medicine for Ebola. It’s OK as far as it goes, but it’s an exception to the FDA’s reluctance to approve the use of life-saving products. Safety and efficacy testing of the drug, designated TKM-Ebola, has barely begun, and quantities are extremely limited. It will be given to patients with confirmed or suspected Ebola infections, but not as part of a clinical trial. As a 15-year veteran of the FDA, that decision surprised me — not because it was bad on the merits, but because it represents a peculiar setting of priorities. To put it less charitably, FDA routinely drags its feet on the approval of products critical for the prevention or treatment of fatal diseases that are far more common in this country than Ebola. Why expend the agency’s time and energy on a drug that will be used rarely,...