Agency Deficiencies Focus of Newly Proposed Scientific Subcommittee

Posted 22 August 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration's (FDA) Science Board will consider a motion to establish a new subcommittee at an October 2012 meeting that will seek to revisit some of the problems raised in a landmark 2007 report about scientific deficiencies at FDA.

That report, FDA Science and Mission at Risk(2007), was prepared by the Science Board's Subcommittee on Science and Technology, and leveled three charges against FDA: Its scientific base is weak and eroding; FDA has insufficient regulatory capacity or capability to accomplish its mission; and the agency's information technology infrastructure is inadequate to accomplish its mission.

FDA Regulators in a 'Fire-Fighting Posture'

"The nation is at risk if FDA science is at risk," claimed the report, and then-present deficiencies were only likely to grow in response to increasing demands on the agency and increasing resource constraints.

Scientific advancements, in particular, were highlighted as being one source of extraordinary pressure on the agency. "FDA's inability to keep up with scientific advances means that American lives are at risk," the subcommittee wrote. "While the world of drug discovery and development has undergone revolutionary change - shifting from cellular to molecular and gene-based approaches - FDA's evaluation methods have remained largely unchanged over the last half century."

"Due to constrained resources and lack of adequate staff, FDA is engaged in reactive regulatory priority setting or a fire-fighting regulatory posture instead of pursuing a culture of proactive regulatory science," continued the Subcommittee.

Establishing a new Subcommittee

In its 22 August Federal Register posting, the Science Board said it was looking to establish a new subcommittee to evaluate the agency's progress in making changes to address the deficiencies raised in the report, as well as several other areas in which the agency has been making changes. 

The science board said it intends to receive updates from the Center for Devices and Radiological health (CDRH) regarding its Research Review subcommittee and Global Health subcommittee, from FDA regarding its 2011 Strategic Plan for Regulatory Science, and from research conducted by the Center for Biologics Evaluation and Research.

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