OMB Memo Outlines All FDA Guidance’s Will Be Reviewed by the White House Prior to Publication

The Trump administration recently issued new guidelines that will expand White House and congressional oversight and review of federal agencies’ rule-making processes, including those for traditionally independent agencies. This will have an especially important impact on the work of the FDA.

Impact on FDA

Generally, FDA releases draft and final guidances to help industry understand the agency’s thinking on a subject. Regulatory Focus notes almost 100 draft guidance documents are intended to be released by just the Center for Drug Evaluation and Research alone. This causes some confusion as to whether the agency regulates based on the non-binding guidance documents.

The article notes an example in December 2015, when FDA released a quality metrics draft guidance related to manufacturing data. Industry pushed back, suggesting the FDA should instead go through notice-and-comment rulemaking procedures to allow industry more meaningful input in the process.

Additionally, members of Congress have raised concerns over the FDA’s overuse of draft guidances in carrying out its regulatory work. There has even been recent legislation proposed to further congressional oversight of federal regulations.

The Memo

The 15-page memo, issued by Office of Management and Budget acting Director Russell Vought, outlines how the OMB’s Office of Information and Regulatory Affairs will be granted further jurisdiction in the regulatory process for all agencies. The memo requires agencies to submit regulations and official guidance to the Office of Information and Regulatory Affairs in order to determine whether the proposed rules are “major” or “minor.”

In its memo, OMB stated the Congressional Review Act applies to not just notice-and-comment rulemakings, but also “encompasses a wide range of other regulatory actions, including, inter alia, guidance documents, general statements of policy, and interpretive rules.” Any guidance document deemed major by the Office of Information and Regulatory Affairs would then have to be reviewed by Congress.