Fighting Back – Pharma Objects to FDA’s Last Minute Obama-Era Guidances

As we noted in last month’s issue, the FDA issued a slew of last-minute Obama Administration guidances. Overlooked among all the guidances was a Final Rule regarding tobacco products and their regulation. Several Industry groups banded together and submitted a Citizen’s Petition to the FDA, requesting a stay of the rule. This article outlines the regulation, the petition, and the FDA’s response.

Recently, the United States Food and Drug Administration (“FDA”) issued over a dozen draft and final guidances in the last days of the Obama Administration, likely anticipating that the Trump Administration would impose a regulatory slowdown. Among the new guidances, there were several that touched upon communication between manufacturers, patients, and physicians. However, in addition to the guidances, there was a clarification document (Final Rule) that remained in the shadows until the industry brought it into the limelight by filing a citizen’s petition, requesting a stay.