Sen. Pat Roberts (R-KS) earlier this month offered an amendment that would require greater transparency by FDA when the agency publishes regulatory guidance. The amendment to S 2700, the FDA and NIH Workforce Authorities Modernization Act, calls for FDA to explain why the interpretation or policy set forth in a guidance is being provided in that non-binding guidance instead of being established through rulemaking. It also requires FDA to identify each specific statutory provision or regulation being interpreted in the guidance or authorizing a policy decision described in the guidance. Read more...

During discussion of the amendment, Sen. Orrin Hatch (R-UT) noted the importance of FDA transparency across all areas the agency regulates, citing the Dietary Supplement Labeling Guide Guidance, released in April 2005. That guidance was recently revised after industry alerted the agency in 2009 to issues therein regarding conflicts between the guidance and the Food, Drug, and Cosmetic Act’s requirement for the statement of identity for dietary supplements. Sen. Hatch observed, “if guidances are not legally binding, but relied upon by states and courts, then FDA needs to apply more scrutiny to these guidance documents so mistakes such as this cannot occur, and if they do, FDA must commit to correct them more quickly.” For more information, contact Ingrid Lebert (202-204-7699).

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