December Monthly Topic:

Conflicts of Interest and FDA Advisory Committee Members
Under the Food and Drug Administration Amendments Act of 2007

The recently enacted Food and Drug Administration Amendments Act of 2007 (“FDAAA”), which took effect on October 1, 2007, establishes new rules to address potential conflicts of interest of members of Food and Drug Administration (“FDA”) advisory panels.  Under the FDAAA, when an advisory committee member has a financial interest in a particular matter before the committee, that member must be excluded from the discussion and their vote withheld on the matter unless a waiver of the conflict is granted by the agency.(1)  The scope of the conflict waiver can be narrow, allowing only participation in panel meetings or hearings, or broad, allowing the member to participate and vote.  The Secretary is required to disclose each conflict on the FDA website.  A notice describing the conflict and the reasons for granting a waiver, if applicable, must also be included as part of the public record.  The new rules clarify the prior FDA waiver criteria issued in 2000, which called for the agency to assess whether the need for an individual’s expertise outweighed the potential for a conflict of interest.  Although some in Congress have called for a ban on all waivers, the Act seems to recognize the growing ties between the medical community, industry, and Wall Street.     

Per the new FDAAA provisions, on October 31, 2007, FDA issued a draft guidance to establish a consistent public disclosure process for conflict-of-interest statements and waivers granted by all of the agency’s centers.(2)  According to the draft guidance, FDA will request that potential advisory panel members publicly disclose the type, nature, and magnitude of any disqualifying financial interests by submitting a signed disclosure statement.  If the agency grants a waiver, the signed disclosure statement and the agency’s waiver will be posted on the agency’s website at least 15 days prior to the meeting.  However, if FDA becomes aware of disqualifying financial interests less than 30 days before the meeting takes place and a waiver is issued, the agency will post these documents as soon a practicable, but not later than the day of the meeting.  The agency also plans to post a roster of all advisory committee members scheduled to attend a given meeting at the time the briefing materials for that meeting are posted. 

The draft guidance includes a sample disclosure form alluding to the $50,000 threshold for advisory panel conflicts of interest that FDA proposed in its draft recommendations for determining such conflicts-of-interest in March 2007.  Typically, the agency plans to exclude advisory panel members with conflicts of more than $50,000, while members with conflicts of $50,000 or less will be allowed to participate, but not vote.  Despite this, the FDA Commissioner may make exceptions when the value of the conflicted member’s expertise outweighs concerns about the conflict. 

According to a recently conducted analysis commissioned by FDA, the ability to grant exceptions to the $50,000 threshold rule may prove more valuable than originally expected.(3)  According to the report—“Measuring Conflict of Interest and Expertise on FDA Advisory Committees”(4)—issued last month by the Eastern Research Group (“ERG”), granting conflict-of-interest waivers is necessary to obtain the most highly qualified advisory committee participants. 

The ERG report discusses the relationship between the expertise and financial conflicts of interest for the 124 standing members of 16 FDA advisory committee meetings that took place between December 2005 and October 2006.  Using a complex index based on years of clinical expertise, total years of experience, total publications, and scientific productivity, the report concludes that members having higher levels of expertise are more likely to be granted conflict-of-interest waivers when compared with members having lower levels of expertise.  Additionally, the report finds that many alternative participants with expertise similar to that of current standing committee members would also require conflict-of-interest waivers.  Based on these findings, ERG concluded that while replacing the waiver participants may be possible, it would be challenging, time consuming, and expensive.

The report also identified an often overlooked aspect of advisory panel conflicts-of-interest:  competitor conflicts.  The report found that more than three times as many members have conflicts-of-interest with a competitor than have conflicts-of-interest with a given product sponsor.  And half of those members with product sponsor conflicts also had conflicts with a competitor.  These findings call into question an underlying assumption of many critics of conflict-of-interest waivers—namely, that conflicts of interest bias the committee in favor of the sponsor’s product.  This is especially true since, on average, the financial values of conflicts related to competitors were found to be more than seven times greater than those related to product sponsors.