August 30, 2021
Guidance on guidance
Married folks know that sometimes “I think X is a good idea,” really means, “We are GOING to do X.” And FDA’s guidance docs sometimes felt the same way.
But (as FDA Law Blog explains), in 2017 the Trump administration made it clear that “guidance” docs could not “create rights or obligations binding on persons or entities outside the Executive Branch (including state, local, and tribal governments).”
Now, though, the Biden administration has reversed that — sort of. There are cases when guidance can be taken into account, per Attorney General Garland.
The Attorney General now instructs DOJ lawyers handling an enforcement action that they “may rely on relevant guidance documents” in instances when a guidance document “may be entitled to deference or otherwise carry persuasive weight with respect to the meaning of the applicable legal requirements.”