Regulatory Focus™ > News Articles > US Regulators Consider Formation of New Advisory Subcommittee to Study 'Data Liberation'

US Regulators Consider Formation of New Advisory Subcommittee to Study 'Data Liberation'

Posted 29 January 2013 | By Alexander Gaffney, RAC

The US Food and Drug Administration's (FDA) Science Board-an advisory board focused on the mission and competencies of the agency-will soon meet to start the process of reassessing a landmark 2007 report in which it described FDA as being in a state of decline.

Background

The report, FDA Science and Mission at Risk, was prepared in 2007 by the Science Board's Subcommittee on Science and Technology. In it, the board raised three principal points against FDA: that its scientific base was weak and not keeping pace with current developments; that its information technology structure was deficient; and that it has insufficient regulatory capacity and staff capability to accomplish its mission.

The report went on to note that regulators were in a "fire-fighting posture" as the result of a lack of resources, the demands for which were only likely to increase as time went on. Resource demands were having a particularly deleterious effect on FDA's ability to keep up with scientific advancements, it said. Its inability to do so "means that American lives are at risk," it added.

Since then, FDA has been endeavoring to shore up its weakest areas, and has persuaded the pharmaceutical and medical device industries to buy into enhanced user fee acts that funnel additional money to the agency to buttress its regulatory science initiatives.

But if recent reports, such as one published in November 2012 by the Partnership for Public Service (PPS), are to be believed, work remains to be done.

"From our review, we discovered that the FDA has made progress since the Science Board issued its findings, including taking steps to expand its workforce," PPS explained in its report. "But we also found that the FDA continues to have significant workforce and management challenges in the scientific and medical arenas that need to be addressed for the agency to fulfill its public health obligations to the American public and its responsibilities to the industries it regulates."

The good news: FDA has been on a hiring spree, adding thousands of employees to its ranks-3,552 between 2007, when the report came out, and 2010, to be precise. That new staff comes with a caveat of sorts: though it's gotten new staff, it's gotten a considerable number of new responsibilities as well, such as heightened pharmacovigilance monitoring, tougher quality standards and more robust review schedules.

Mission at Risk: Update

Now, the government is making clear that it plans to conduct its own review, starting at a 27 February 2013 meeting of the Science Board. In August 2012, the Science Board reconstituted its subcommittee on Science and Technology, and issued a call for new members shortly thereafter.

FDA's 29 January 2013 Federal Register posting provided for the first time an in-depth look at what the committee plans to revisit from the 2007 report.

The Science Board will, for example, see a proposal for the newly founded subcommittee to reassess many of the same issues the 2007 report dealt with.

But the Register notice also indicates a new announcement as well: the Science Board is considering the formation of a second subcommittee that would study the agency's scientific data utilization, data liberation and innovation.

The data liberation point could potentially be taken to mean that the agency is assessing whether or not to follow its EU regulatory counterparts, who have called for more clinical trials data to be made public. Conversely, it might also be taken to mean FDA is interested in putting more information generated from products-medical devices and diagnostics-into the hands of consumers for their own private use.

FDA's Martha Monser, in a response to Regulatory Focus, said the agency took the term as describing "data sharing (pre-competitive or otherwise) as well as secondary use of data."

"For example, using electronic medical record data for drug discovery research," she added.

Also being discussed will be FDA's "cross-cutting genomics activities" and updates from FDA's Center for Devices and Radiological Health Research Review subcommittee and Global Health subcommittee.

The meeting will be held on 27 February at FDA's White Oak Campus in Silver Spring, MD.


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