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FDA Charts Transparency Plans

By a GenomeWeb staff reporter
NEW YORK (GenomeWeb News) – The Food and Drug Administration has issued a report detailing its plans to enhance the agency’s transparency and communications efforts to the industries it regulates, which include the recent launch of a website to provide companies with submission and regulatory information, and it is seeking public comments on some of these plans.

The three-phased FDA effort includes 19 total steps it plans to take to make basic information about the FDA more accessible, to make agency activities more transparent, useful, and understandable to the public, and to address ways the agency can be more transparent in order to foster a more efficient, and cost-effective regulatory process.

The FDA Transparency Initiative was developed in response to a charge in a White House memo from 2009 to develop and implement in many agencies policies that would create "an unprecedented level" of government openness that will "strengthen our democracy and promote efficiency and effectiveness," in government.

"Clarity and consistency are pillars of an effective regulatory system that efficiently regulates products essential to health," FDA Commissioner Margaret Hamburg said on the launch of the website earlier this month.

"In order to succeed, the FDA must clearly communicate standards and expectations to the industries it regulates," she added.

In addition to the FDA Basics for Industry website, the initiative outlined in the report, "FDA Transparency Initiative: Improving Transparency to Regulated Industry," includes policies for answering e-mail questions, making agency presentations more available, and promoting uniform processes and procedures.

The report also includes five draft proposals for steps the agency can take to improve its transparency specifically to the industries it regulates, and it is seeking public comment on these until early March.

These draft proposals include publishing a timeline on the FDA website for high important guidance documents that are in development, disclosure of dates of publication for such guidance, as well as receipt of public comments and the publication of the final guidance.

Under one of the draft proposals, FDA would maintain on its web site a list of the presentations given by its employees to external audiences. Another draft proposal would require that the Office of the Commissioner inform people who submit requests for reconsiderations of FDA scientific decisions within three weeks if OC will review that request and when an update on the status of the review may be expected.

Other draft proposals describe steps the agency should take to initiate a web-based system for providing information about importing requirements and reviewing existing procedures for reviewing importers.

"We have heard from small and large companies about the need for the FDA to more clearly communicate about its standards and expectations – both for regulated products generally and for specific applications," added Principal Deputy Commissioner Joshua Sharfstein and chairman of the agency’s Transparency Task Force.

The agency also has established an online performance program for FDA offices, FDA-TRACK, that provides monthly metrics for more than 100 agency offices and provides insight into FDA’s decision-making and regulatory agencies.

Some other steps that the task force included in its proposed plans include: FDA will update the agency organizational charts and senior personnel changes on its website on at least a quarterly basis; FDA will provide links to the processes available for industry to submit general regulatory questions to each of the agency’s centers; FDA will aim to respond to general questions about policies and regulations submitted via e-mail within five days; FDA will issue a final version of its Strategic Priorities FY 2011 – 2015 by March of this year; and FDA will post on its website slide presentations that are delivered by FDA employees to external audiences at agency-sponsored events.

FDA also said that it is willing to hold further discussions with industry about application tracking systems, and consider if such a system could be implemented at the agency.

Other action items the report calls for cover methods FDA will use in conducting outreach and receive input on its rulings, ways FDA will work with the Department of Health and Human Services and the Office of Management and Budget to make improvements, and steps the agency should take to improve transparency to the importing community.

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