Scott Gottlieb And The Goldilocks Theory Of Bringing Change To The FDA

With the nomination of Dr. Scott Gottlieb to head the U.S. Food and Drug Administration (FDA) headed to the Senate floor, we can expect another Goldilocks debate. Like the heroine of the classic tale who famously tested the three bowls of porridge to find one too hot, one too cold, and one “just right,” participants will debate whether today’s FDA is too lenient, too tough, or just right in reviewing new prescription drugs. That Dr. Gottlieb is qualified for the role he has been nominated for appears beyond question. What critics take issue with is whether his extensive experience ties him too closely to the entities he would be charged with regulating and whether his previously expressed views show a disregard for the FDA’s essential public health role. His supporters will counter that his detailed knowledge of the industry will make him a more effective regulator of bad behavior and that his writings demonstrate that he’s given thought to the toughest issues. Those who seek to judge what he would do as leader of the FDA try to discern where he will come down on the porridge question. This question, as simple as a fairy tale, is also shockingly simplistic. It masks the far more complex challenges that, if confirmed, Dr. Gottlieb will face. For today’s debate is more about the limits of science to deal with the inevitable uncertainty about the safety and effectiveness of new medicines and the proper role of the FDA in encouraging innovation as it protects public h...
Source: Health Affairs Blog - Category: Health Management Authors: Tags: Costs and Spending Drugs and Medical Innovation Health Professionals Public Health 21st Century Cures Act Big Pharma FDA off-label drugs off-label promotion Source Type: blogs