Where Is the OIRA Oversight of FDA Guidance Documents?

From: Mercatus Center

Richard Williams, James Broughel

Federal agencies issue guidance documents that typically consist of sets of instructions or announcements written to inform regulated parties how to stay in compliance with the law. Owing to a confusing set of events, it is unclear whether these documents are receiving executive branch oversight from the Office of Information and Regulatory Affairs (OIRA). In the case of the Food and Drug Administration (FDA), hundreds of guidance documents appear on its website, yet there is almost no evidence of oversight from OIRA.

On January 23, 2007, then-President George W. Bush issued Executive Order 13422, requiring executive branch regulatory agencies to submit their significant guidance documents for review by OIRA. OIRA, an office located within the Office of Management and Budget, was already tasked with reviewing other significant regulatory actions to ensure that such actions are supported by strong technical evidence. As such, it was natural for the same office to review guidance documents likely to have significant impacts. Upon entering office, President Obama repealed President Bush’s executive order.

Read Complete Article

Leave a Reply

Name not required for anonymous comments. Email is optional and will not be published.

Please Answer: *