Advocacy - Lab Advocate
AACC recently endorsed Rep. Pete Sessions (R-TX) legislation, H.R.6283, the “Truth in Regulations Act of 2016,” which would increase the administrative requirements on regulatory agencies using guidance. Over the past decade, the FDA alone has issued more than 600 guidance documents making this policy option the norm rather than the exception. Agencies often choose guidance to avoid responding to public comments or conducting a cost-benefit analysis of the proposed policy change.
If enacted, H.R.6283 would change this process. The bill would require that:
- “Significant guidance” receive the approval of appropriate senior officials;
- That mandatory language be excluded (e.g., the use of the term “must”);
- The documents be posted on the internet and made available for public comment; and
- An agency publically responds to comments received regarding “economically significant” guidance documents.
AACC agrees with these recommendations. AACC also suggested that Rep. Sessions amend the bill to require that agencies issuing an “economically significant” (those policy changes costing more than $100 million annually) guidance perform and publish an economic impact analysis of that policy to better inform the public about the costs and benefits associated with the suggested change. Although Congress is unlikely to take up the bill this year, Rep. Sessions is likely to re-introduce the measure in 2017.