The Food and Drug Administration’s (FDA’s) advisory committees play an essential role in FDA’s activities to protect and promote public health through the regulation of human and animal drugs, biological products, medical devices, foods, and tobacco products. FDA’s advisory committees provide independent expert advice and recommendations to the Agency on scientific, technical, and policy matters related to FDA-regulated products.
Advisory committees enhance FDA’s ability to protect and promote public health by ensuring FDA has access to such advice through the public hearing process as provided in existing laws and regulations. Although advisory committees provide recommendations to FDA, FDA makes the final decisions on any matters considered by an advisory committee.
FDA encourages participation from all public stakeholders in its decision-making processes. Every advisory committee meeting includes an open public hearing (OPH) session, during which interested persons may present relevant information or views orally or in writing.
Consequently, last month FDA issued a guidance for the public, FDA Advisory Committee Members, and FDA Staff regarding “The Open Public Hearing at FDA Advisory Committee Meetings.” The guidance includes details about:
– How to provide a request to speak or present at an OPH
– What information to provide in the request to speak or present
– FDA’s process to confirm a speaker or presentation
– Checking in procedures on the day of the meeting
– Submission of presentations; and
– Logistics of an oral presentation
Financial Disclosure
According to the guidance, “the law requires that FDA’s advisory committee members who are special Government employees (SGEs) or regular Government employees (RGEs) disclose to FDA potential financial interests related to the topic of the advisory committee meeting, including relationships that they may have with the sponsor and competitors of the product(s) under discussion, when the committee addresses a particular matter involving specific parties4 or a particular matter of general applicability.
The financial interests that must be reported include stocks, grants, consulting, teaching, speaking and writing engagements, expert testimony, patents, and royalties. In addition, the financial interests of a spouse, minor child, employer, officer, director, trustee, or partner are imputed to the committee member.
In its new guidance, the FDA encourages OPH speakers to disclose financial relationships they may have with the topic of the meeting and parties (e.g., sponsor and competitors of the product(s) under discussion). The guidance also recommends that at the commencement of each OPH session, the Chair of the advisory committee meeting read a statement addressing the issue of financial disclosure for all open public hearing speakers. The guidance offers two statements for the Chair to read:
– “If you have any financial interests relevant to this meeting, FDA encourages you to state the interest as you begin. Such interests may include a company’s or group’s payment of your travel or other expenses, or grant money that your organization receives from the sponsor or a competitor;” or
– “If you have any financial interests relevant to this meeting, such as a financial relationship with any company or group that may be affected by the topic of this meeting, FDA encourages you to state the interest as you begin.”
The guidance also instructs speakers that if they do not have any such interests, to state that for the record. If a person prefers not to address financial interests, they can still give comments. After each presentation, the Chair or a committee member may question the person concerning his or her presentation. However, neither the Chair nor any committee member should further question the person regarding any potential financial relationships.
In addition to members of the public, it applies to representatives from regulated industries, consumer advocacy groups and professional organizations, societies or other groups invited to speak. The final guidance will affect meetings starting in March.