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Compliance In Focus
Posted by John Lehmann on Tue, May 8, 2012

FDA Required to Write Rudimentary Regulations?

Writing the RegulationsIn late April a bill was to congress by a group of bipartisan Senators: Claire McCaskill, Susan Collins, and Tom Coburn.  This bill, “Plain Writing Act for Regulations of 2012,” hopes to accomplish just what the title indicates- require the regulations use plain writing to increase public understanding and participation in the process. What is plain language? A quick internet search yielded this government definition, “communication your audience can understand the first time they read or hear it. Language that is plain to one set of readers may not be plain to others.”

The legislation sets forth the following criteria for plain writing:
• Clear
• Concise
• Well-organized

Also included in the bill is the responsibility of a guidance being published 6 months after the enactment of the Act. The guidance is for understanding and ensuring that the “obligation of the agency to use plain writing does not in any way diminish the ability of the agency to perform scientific analyses or technical analyses, or disclose scientific data or technical data or any other findings, that are required to be performed or disclosed by Chapter 5 of Title 5, United States Code, or any other provision of law.”

Does any of this sound familiar? In January of 2012, Republican Bruce Braley, introduced a bill titled, “The Plain Regulations Act.” And according to the press-release, “examples of lengthy, overly complex regulations abound” and the bill “would require the government to write new and updated regulations in clear, simple, easy-to-understand language.”

Do you think the FDA should be required to write the regulations in a plain and simple language style? Looks like quite a few Senators do! Or, will this in fact make it more difficult for the agency to disclose scientific data or findings? Let us know what you think.

Photo Credit: J. Paxon Reyes

Topics: Plain Writing Act for Regulations of 2012, FDA, Regulations

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