Between regulatory rocks and hard places: Quantifying tolerance for pharmaceutical risks
Johnson, F. R. (2008). Between regulatory rocks and hard places: Quantifying tolerance for pharmaceutical risks. In Presented during the Second Plenary Session, #8220;Drug Safety and Risk-Benefit Decision-Making,#8221; at the ISPOR 13th Annual International Meeting, May 6, 2008, Toronto, ON, Canada, , pp. 6–8. .
One of the reasons for the current interest in benefit-risk assessment is the recurrence of embarrassing regulatory situations. A recent example involving synthetic blood products was widely reported in the media. Sixteen studies found that synthetic blood products were associated with tripling the risk of heart attacks and increasing the chance of dying by 30%. Researchers publicly questioned the competence of the Food and Drug Administration bureaucrats who allowed additional testing of these products to continue. An FDA official interviewed said that agency experts had carefully scrutinized the evidence and were satisfied that the potential benefits outweighed the risks of further testing and pointed out the huge unmet need for synthetic blood. A successful blood substitute could save thousands of lives of trauma patients (Washington Post, Tuesday, April 29, 2008).