In my second letter to Sen. Johnson, that I sent on June 1st, I told him that I had a feeling the FDA would likely respond with a copy of the Final Regulatory Impact Analysis/Final Regulatory Flexibility Analysis/Unfunded Mandates Reform Act Analysis (FRIA). It is a very troubling document, even more confusing and contradictory than the Final Deeming Rule.
It's pretty astounding that in the introduction the FDA states,
"The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. We find that the final rule will have a significant economic impact on a substantial number of small entities."
Then it goes on for 156 pages saying
we don't know, the market is growing too fast to have accurate info, blah, blah, blah.
I wrote a long message to Sen. Johnson advising that if the FDA sent the FRIA, claiming it somehow answered his questions, to read it very carefully. I then quoted several passages that were of particular concern.
I'm not holding my breath that Sen. Johnson will have a significant impact on the FDA, but I appreciate his questions and common sense. I welcome anything that will get our perspective attention.
ETA: Warning! This report may cause seizures.
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM500254.pdf