Regulatory Focus™ > News Articles > Proposed Legislation Would Require FDA to Develop Guidelines to Ensure Scientific Quality

Proposed Legislation Would Require FDA to Develop Guidelines to Ensure Scientific Quality

Posted 10 July 2012 | By Alexander Gaffney, RAC 

A bill proposed in late June 2012 by a bipartisan group of congressmen would require all federal agencies, including the US Food and Drug Administration (FDA), to develop guidelines to ensure "scientific information relied upon by the agency" meets a number of quality standards.

The bill, H.R. 5952-To require each Federal agency to submit and obtain approval from the Director of the Office of Science and Technology Policy of guidelines for ensuring and maximizing the quality, objectivity, utility, and integrity of scientific information relied upon by the agency ('The Act'), is sponsored by Rep. Don Manzullo (R-IL) and co-sponsored by six other representatives.

The Act would require agencies to issue guidelines by 1 January 2013 to ensure the "quality, objectivity, utility and integrity of scientific information relied upon" by each agency. The guidelines would specifically need to show the scientific information used by each agency is subject to good scientific processes, is applied to each policy decision appropriately, made available to the public, weighed appropriately and subject to public comment where appropriate.

Agencies will also need to have in place procedures for determining and reviewing whether scientific information at an agency has been "compromised," though the act neglects to state what the term means.

The law would also prevent any policy decision from taking place before the scientific guidelines are in place, which must be approved by the Director of the Office of Science and Technology Policy.

The bill has been referred to the House Committee on Oversight and Government Reform, which is chaired by Rep. Darrell Issa (R-CA).


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