Gifts to FDA: FDA’s Strangest Guidance Document  
[Posted on: Thursday, July 7, 2016]

A new draft Guidance Document on “Gifts to FDA” could be one of the strangest documents of its kind released by the Agency in its history. The document defines a “gift” to the FDA and then details the various rules that would govern the evaluation and acceptance of such gifts. Only the FDA Commissioner is authorized to accept gifts on behalf of the Agency. A "gifts" means anything of monetary value given to FDA as an institution, including competitive grants awarded to FDA employees as part of their official duties, including: funds for either general or specific purposes, data, materials, items, information, or services. The reason this guidance is strange is because there already exist several rules governing gifts to government officials, including paying for travel for FDA officials to attend conferences and meetings. The multiple ethics rules and policies already cover in great details all areas of concern and ways to address the same. So, this new Guidance Document seems redundant. Some things such as not accepting a gift from a debarred person may seem obvious as would be accepting a “conditional” gift where the donor expects a favorable decision or action by FDA. The intent of the Guidance is not obvious; it seems too innocuous at the same time important enough for FDA to dedicate resources to create it. The timing seems odd. Just last week it was reported that the current FDA Commissioner, Dr. Califf, received a consultation fee from AstraZeneca. The date of the payment indicates that the payment was made days before Dr. Califf joined FDA. Hence there does not seem to any ethics issues with the payment except for the negative perception. FDA even created a new page to track all gifts to the Agency, which at the time of this writing was blank. Giving “gifts” to any government official or agency is always discouraged; no matter the intent of the donor, the perceptions are hard to control. Common sense should rule any interaction that may create hard-to-explain situations. For now, we can file this Guidance Document in the list of strange never-to-be-needed advice.