Life Sciences Lawyer Questions FDA’s Timing of Guidances, Rule


The FDA’s release of guidances for medical products communications and its publication of the intended use rule this month are nothing more than last-minute maneuvering, according to a former FDA official.

“These documents are being released late in the administration for a reason,” Coleen Klasmeier, a lawyer with Sidley Austin in Washington who was with the FDA’s Office of Chief Counsel, told me Jan. 18.

The documents in question are two draft guidances on manufacturer communications about medical products released Jan. 18 and a final rule on intended uses of drugs, devices and combination products published Jan. 9.

The first guidance contains recommendations to drug and device makers about how to communicate with payers, such as health insurers (Docket No. FDA-2016-D-1307). The second guidance explains how the FDA evaluates medical product communications, including promotional materials, that present information that isn’t in the FDA-approved labeling, but that refers to a product’s approved use (FDA-2016-D-2285). The agency also released a memorandum laying out issues it’s sorting through as it attempts to overhaul its policies on what manufacturers can say about the off-label uses of their products.

The new final intended use rule from the FDA clarifies for manufacturers when the agency will regulate tobacco products as drugs or devices and also contains amendments to regulations regarding intended uses.

"This area is fraught for FDA, and the timing indicates that agency—and especially HHS—officials are hoping to affect the incoming administration’s approach,” Klasmeier told me.

And, she said, the final intended use rule is “an eleventh-hour maneuver that was not the subject of proper notice in the 2015 proposed rule and further reflects the outgoing administration’s desire to tie the hands of the incoming team.”

The final rule intended use rule is at The guidance on communications with payers is at The guidance on communication about approved uses is at The FDA's memorandum is at

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