New FDA Guidance: How to not give Gifts to the Agency

Recommendation

13/14 December 2023
Berlin, Germany

Root Cause Analysis
A CAPA Workshop on Successful Failure Investigation

The U.S. Food and Drug Administration (FDA) has published a new Draft Guidance for the Public and FDA Staff "Gifts to FDA: Evaluation and Acceptance".

This is a rather interesting document for two reasons:

• The timing of the publication: just recently it was reported that the current FDA Commissioner, Dr Robert M. Califf, received a consulting fee from AstraZeneca. However, the payment was made before Dr Califf joined FDA.
• It seems to be a little redundant: There are already quite a few guidance documents in place like for example CFR Part 2635-Standards of ethical conduct for employees of the executive branch.

So what is it about? The FDA defines what a "gift" is and what needs to be considered when a gift is offered. A "gift" means anything of monetary value, including competitive grants, funds for either general or specific purposes, data, materials, items, information, or services. Basically only the FDA Commissioner is authorised to accept gifts on behalf of the Agency.

FDA has also created a web page to track all gifts to the Agency.