Should FDA restructure its drug review process

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  • #FDA efforts to resolve scientific differences are causing it to miss review goals that it commits to as part of the #PDUFA @ScottGottliebMD

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  • Managers leave it to FDA’s external advisors to resolve disputes, rather than work to reach an internal consensus through the agency’s scientific process @ScottGottliebMD

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  • Complex scientific views are the product of agreement formed among experts with diverse training, who hail from different disciplines and backgrounds @ScottGottliebMD

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In recent years, the Food and Drug Administration (FDA) has struggled with an increasing number of disagreements among its scientific staff. Many of these disputes have spilled out into public view. There seems to be less unity around hard decisions and more instances where FDA staff labor to collaborate and work toward a consensus opinion. A growing number of these disagreements are being brought before FDA’s public advisory committees for mediation. The agency’s efforts to resolve scientific differences and to take final actions are causing it to miss review goals that it commits to as part of the Prescription Drug User Fee Act (PDUFA).

"When experts from these different silos disagree, there is a waning expectation that they should sort through their differing interpretations of data to reach a scientific accord." -- Scott Gottlie

To some degree, these events are a product of the broader political environment in which FDA must operate. Congressional and media scrutiny celebrates the notion of a lone “whistle-blower” tilting against the prevailing orthodoxy. This can feed an internal culture that encourages individuals to cling to dissenting opinions, even when those views are rejected by more senior FDA scientists. The political culture spooks managers away from challenging scientists who cling to outlying conclusions, even in cases where those opinions are based on flawed analysis.

The increasing preference has been to sidestep these internal disputes by bringing them before the agency’s public advisory committee meetings. The resulting transparency insulates managers from charges that they “suppressed” dissenting views or intervened to guide the decision to a particular outcome. Managers leave it to FDA’s external advisors to sort out these disputes, rather than work to reach a definitive, internal consensus through the agency’s scientific process.

While this practice may be politically expedient it is an inefficient way to run a scientific enterprise. It also reduces FDA’s ability to leverage the collective wisdom of its scientific personnel. Complex scientific views are the product of agreement formed among experts with diverse training, who hail from different disciplines and backgrounds. But at FDA, experts from different scientific disciplines work in silos. When experts from these different silos disagree, there is a waning expectation that they should sort through their differing interpretations of data to reach a scientific accord. The disagreements are too easily “turfed” to advisory committees to be resolved. While the political culture is pressuring the agency toward these ends, the agency’s organizational structure may also be contributing to a lack of collaboration by discouraging opportunities for collaboration inside the drug review process.

Scott Gottlieb, M.D., is a resident fellow at AEI.

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