On Monday, the FDA updated several policies and procedures for advisory committees, including implementing stricter limits on financial conflicts of interest, new voting procedures and changes to the processes for disclosing information. However, some have questioned the necessity or motivations of the alterations.
The FDA instituted a $50,000 cap as the maximum personal financial interest an advisor may have in all companies that may be affected by a particular meeting.
If an advisor’s personal financial interest is less than $50,000, FDA officials may, in certain situations, grant a waiver, but will do so only if they determine that there is an essential need for the advisor’s particular expertise.
Waivers, which include a description of the advisor’s personal financial interest and why the need for the expertise was essential, will be posted on the FDA’s website in advance of the meeting.
In recent years, despite the concerns by some about financial conflicts influencing the decisions of committee members, the FDA has been hesitant to act because it has feared that stricter rules might eliminate many qualified advisors.
Others claim that the FDA’s concerns about financial conflicts of interest are unfounded. In fact, researchers at Public Citizen and the University of California looked at the agendas and transcripts from all FDA Drug Advisory Committee meetings from 2001 to2004. In just under three-quarters of the meetings, at least one advisory committee member or voting consultant disclosed a conflict; and only 1 percent of advisory committee members were disqualified from participating (Lurie, P. et al, JAMA, 295:1921–1928; 2006).
The JAMA researchers found that there was no statistically significant relationship between conflict rates and voting patterns. Lurie and colleagues detected a weak relationship between certain types of conflicts, such as considering a competitor's drug, and voting behaviors. However, excluding advisory committee members and voting consultants with conflicts would not have altered the overall vote outcome at any meeting examined by the researchers.
“It’s imperative that we seek advice from independent experts, and that we do so in a way that is public, open and transparent,” said Randall Lutter, PhD, deputy commissioner for policy.
Another FDA change addresses the public availability of briefing materials. The agency will post briefing materials given to the committee prior to a meeting on the FDA’s website at least 48 hours in advance of the meeting.
The agency also issued recommendations addressing the way that advisory committees will vote on questions, so as to avoid even the perception of any manipulation of votes. It is recommended that advisory committees use a process of simultaneous voting, in which all members vote at once.
The FDA also proposed new criteria to clarify when the agency should refer a matter to an advisory committee. In some instances, the FDA is required by law to refer a matter to an advisory committee. In other instances, the FDA would consider the new criteria when deciding whether to refer a matter to an advisory committee.
The FDA said its policies and procedures are described in four final guidance documents, and proposed changes in policies are described in a draft guidance. Most of the changes in the final guidance documents will go into effect immediately, and all are expected to be fully implemented within 120 days, according to the agency.