Kelsey Award Should Honor Balance Of Safety And Speed

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FDA Commissioner Dr. Margaret Hamburg will honor former FDA official Frances Kelsey, MD, PhD, with the first annual Kelsey Award tomorrow the 50th anniversary of Kelsey s refusal to authorize the marketing of thalidomide in the U.S. to pregnant women for the relief of morning-sickness. The drug was later found to cause birth defects, including malformed limbs, when used early in pregnancy. After Dr. Kelsey s role in averting a public health tragedy was publicized, Congress gave the FDA authority to demand proof of safety before drugs could be brought to market. New York Times reporter Gardiner Harris noted that Dr. Hamburg and others who admire Kelsey s work might use this honor to call on the FDA to take more time to evaluate drug safety a reversal of what he considers an industry-friendly stance of speed before safety.

Honoring her does not have to mean an emphasis on slowing down the evaluation process per se. Her accomplishment was saving lives, and that is what should be emphasized. Unduly impeding drug development by fixating on safety over efficacy will actually cost lives, says ACSH s Jeff Stier. Perhaps those who call for an even slower drug approval approach are trying to hijack Kelsey s record, but they should also honor the unsung heroes who work hard to quickly approve lifesaving drugs.

ACSH s Dr. Gilbert Ross, meanwhile, takes issue with Harris take that the FDA is currently industry friendly. This assertion is completely unjustified, despite occasional well-publicized drug recalls. The FDA has to be the most onerously stringent regulatory body in the world.