Full article reprinted from "The Gray Sheet" - August 10, 2008
FDA should hold voluntary advisory committee meetings only for matters that are of significant public interest or controversy, or that demand unique expertise, the agency's Office of Policy, Planning and Preparedness says in a draft guidance released Aug. 5.
The draft document, Guidance for Public and FDA Staff on Convening Advisory Committee Meetings, applies only to meetings scheduled by FDA at its own discretion. It does not pertain to the other specific situations in which the agency is required, under the Federal Advisory Committee Act and other laws, to consult an expert advisory panel.
The draft recommends that the agency hold an advisory panel meeting for issues that meet one or more of the following criteria: The matter is of significant public interest; the issue is so controversial that a panel meeting would be beneficial; or the issue requires a special type of expertise that only an advisory committee could provide.
"By prioritizing matters according to the factors above, we help ensure that the finite resources of our advisory committee program are devoted to consideration of the most important matters," FDA writes.
According to the guidance, these criteria are often met by pre-market applications for a first-of-a-kind medical product or a significant new indication for an existing product. Other examples include cases in which FDA has significant questions about the product's safety or its use in certain subpopulations.
FDA already attempts to consult advisory panels on all applications for the first of a new class of drugs. The guidance suggests that the agency follow a similar policy for medical devices and other product areas, as well.
If FDA does not refer a first-of-a-kind product to an advisory panel, it should publicize a summary of the reasons it decided to bypass the committee, the draft guidance states.
Guidances Enact Broad Advisory Panel Reforms
FDA also finalized four additional guidance documents Aug. 5, enacting several advisory committee policy changes proposed last year (2"The Gray Sheet" Nov. 5, 2007, p. 19).
The documents were drafted in response to sections of the 2007 FDA Amendments Act requiring more stringent conflict-of-interest policies and encouraging FDA to recruit advisory committee members with minimal conflicting interests. Under the law, FDA agreed to reduce by 5% annually, until 2012, the number of conflict-of-interest waivers granted.
FDA has long screened all potential advisory committee members to see if they have any conflicting financial ties, but the final guidance imposes a $50,000 cap on such ties for panel members, their spouses and dependents.
The cap does not include imputed interests, such as grants awarded to a university that employs the panel member, the final guidance clarifies.
"We had made a very broad-brush cap, but as the public comments pointed out, it's a very different situation when a university receives a grant that is not directly tied to that advisory committee member," Jill Hartzler Warner, FDA senior policy advisor and counselor, said during an Aug. 4 conference call.
If conflicting financial interests amount to less than $50,000, "we'll grant a waiver, provided we determine the waiver is necessary to afford the advisory committee essential expertise," explained Randall Lutter, FDA deputy commissioner for policy. "These policies go well beyond the legal requirements enacted recently by Congress."
There are also scenarios in which FDA will never grant a waiver, such as if the prospective advisor or his or her employer has financial ties to the sponsor of the product under review and the advisor serves as a principal investigator for the product.
According to the guidance, waivers may grant a panelist voting or non-voting status at FDA's discretion - a change from the March 2007 draft, which recommended that panelists granted waivers be non-voting.
"These improvements ... will help ensure that FDA is getting the highest quality scientific advice while at the same time preserving public confidence and trust in our regulatory decisions," Lutter said.
The conflict-of-interest guidance takes effect in 120 days and, beginning Dec. 3, will dictate whether panel members can participate in upcoming meetings. Because the policy only concerns participation in particular meetings, not membership on a committee overall, nobody will lose his or her committee position as a result of the new guidelines.
The other guidances issued Aug. 5 address public availability of committee member financial information, preparation and posting of advisory committee briefing materials and public feedback, and committee voting procedures. These are largely unchanged from the draft versions and are effective immediately (see chart: "3Advisory Committee Guidance Round-up").
Putting Experts To The Test
The new eligibility criteria are intended to limit the participation of members with potential conflicts to "narrow circumstances" in which the conflict is "minimal" and the member's expertise "necessary," the conflict-of-interest guidance stresses.
FDA says it will apply a stringent "essential expertise" test to all waiver candidates, including a needs analysis and, generally, a documented search for an equally qualified expert with few or no financial ties.
The test need not show that it would be impossible to hold the committee meeting without the expert's participation, FDA says, but it "requires more than a showing of inconvenience to the committee or FDA."
For example, for product-specific meetings, a waiver may be granted in the case of products that are so widely studied that it would be difficult to find a qualified expert who was not involved with the product or one of its competitors, FDA says.
"We do feel that this balance [test] will give us the expertise that we need," Warner said.
In the meantime, FDA has significantly stepped up its recruitment efforts to fill advisory committee vacancies and locate "less conflicted" experts.
Warner says FDA has contacted about 280 professional organizations, including AdvaMed and the American Medical Association, attended professional meetings and published six Federal Register notices to seek nominations. So far, the agency has received 350 curriculum vitae for device, drug and other advisory committee experts.
As of Aug. 1, CDRH had 49 openings on its various medical device advisory panels, including four on the Circulatory System Devices panel, six on the General and Plastic Surgery Devices panel and nine on the Molecular and Clinical Genetics panel.
- Jessica Bylander
Register for your 30-day, risk-free trial of "The Gray Sheet"
