What is a financial conflict of interest waiver?

When FDA determines that an advisory committee member has a financial conflict of interest, the agency may grant a waiver that allows the member to participate in an advisory committee meeting if certain criteria and policies are met.

In general, FDA may grant a waiver if the member's expertise is considered essential to the committee’s discussions and recommendations. FDA must also take into consideration a cap on the number of waivers that can be granted each year. FDA searches for experts who have the necessary expertise without conflicts of interest; yet, in some cases, many of the top authorities in specialized scientific fields may have a conflict of interest.

When a waiver is proposed for a member to participate in a particular meeting, FDA follows a rigorous review process. When FDA grants a waiver, the financial interests associated with the waiver are posted on FDA’s website along with the reasons for granting the waiver.

FDA’s process provides the opportunity for the agency to gain access to needed experts to obtain the best scientific and technical advice while also carefully assessing any potential for a conflict of interest.