Advisory Committee Vacancies Remain High As FDA Revs Up Search

With its recent hiring push drawing attention, FDA is quietly undertaking another recruitment effort - filling advisory committee roster vacancies.

Even while FDA labors to implement its Safety First initiative and new authorities granted by the FDA Amendments Act, the agency is committed at the highest levels to process improvements for the agency's advisory committee system, including the more active and systematic approach to recruiting committee participants.

In a recent blog posting, FDA Commissioner Andrew von Eschenbach commented that "our advisory committee function is ... one of my highest priorities in our agency-wide process improvement effort."

Two primary concerns are addressing potential conflict of interest issues and "assuring that we draw from an extensive and rich talent pool of advisors," he wrote.

These two concerns underscore a tension central to the current advisory committee process, as tighter conflict of interest rules shrink the potential pool of members.

Deputy Commissioner for Policy, Planning and Preparedness Randall Lutter said a Web site FDA created last year helps potential applicants with a centralized listing of advisory committee vacancies.

"Internists or statisticians or pediatricians who may have skills applicable to a variety of agency advisory committees don't have to hunt or search through the Web site anymore," he said.

"They don't have to call up six friends here and ask, 'Hey, what openings have you got? I'm interested.' They can find one centralized location."

Professional Outreach

The commissioner has personally met with professional groups such as the American Medical Association, asking them to help the agency identify candidates and encourage their members "to become actively interested and engaged in issues that are before the FDA."

Through these relationships, von Eschenbach hopes to create "a wider and an increasingly expanding pool from which we can bring special government employees, special experts," he said at a November 2007 press briefing.

Other groups that FDA has reached out to include: the American Association of Tissue Banks, Parenteral Drug Association, National Hispanic Medical Association, North American Spine Society, National Foundation for Infectious Diseases, and the Medical Design and Manufacturing Conference.

Shortage Of Committee Candidates Across FDA

Advisory committee rosters currently face a significant shortage of members, with biostatisticians being particularly scarce. For example, a meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee recently convened with only four participants, and the committee currently has 12 openings.

There are membership vacancies on all 16 Center for Drug Evaluation and Research panels - 83 openings for permanent, four-year members in total (see chart: " ¹ CDER Advisory Committee Vacancies ").

The biologics center's five committees have 20 vacancies, and the Center for Devices and Radiological Health has 68 slots to fill.

The Pediatrics Advisory Committee has two openings and the new Risk Communication Advisory Committee has one.

Von Eschenbach announced plans May 30 to bring FDA's Science Board, which already has a deficit of two members, up to 21 members.

In selecting experts for four-year terms as full advisory committee members, FDA seeks to assemble panels with a range of general expertise and perspectives.

Lutter noted FDA has both statutory and "also very strong institutional requirements for balance."

The review divisions, where most of the committees are managed, will request members with different backgrounds, depending on the committee, such as "two endocrinologists, two statisticians, a couple of pediatricians, a couple of anesthesiologists, etc., and that sort of representation is pretty constant," he said.

Changes in committee composition from one meeting to the next are typically a reflection of the issues about which FDA is seeking advice, as the expertise of the standing committee will often be supplemented by temporary members.

"Depending on the subject matter there may be a need for additional experts or a subspecialty that is not represented on the standing committee," Assistant Commissioner for Accountability and Integrity Bill McConagha said.

Lutter said changes in committee composition are "very difficult to generalize about because they are driven by the exigencies of the one meeting."

FDA also uses temporary appointments as a way to evaluate or train candidates for permanent committee membership. "You will see there are many instances in which people who have served as excellent [special government employee] consultants for a period of time will then actually become permanent members later on," Lutter said.

The agency is working both to find permanent members "who meet the legal requirements of balance and, at the same time, make sure that qualified SGEs who are coming in, who are clearly going to be value-added at some point, are included as consultants on a case-by-case basis so that we're not pushing qualified people away," he said.

Conflict Rules Will Sharpen Demand

The demand for expert advice may swell depending on how the agency interprets FDAAA. A provision in the law requires that an advisory committee review be conducted for every new molecular entity unless FDA specifically explains why a meeting is unnecessary.

The agency plans to address the issue through guidance under development that will lay out its criteria for determining when a committee meeting is necessary. FDA has expressed interest in holding more advisory committee meetings, but McConagha suggested that the agency will not convene one for every NME.

While the agency will comply with the law, it is putting careful thought into guidance that will "enable the centers to meaningfully and consistently differentiate between those NME or first-in-kind type products that will be referred to an advisory committee and those that won't," he said.

The challenge of identifying and retaining qualified advisory committee meeting participants will probably intensify going forward as FDA updates its conflict of interest policy, which will further compound the supply and demand situation.

The agency issued a draft guidance that proposes limiting potential financial conflicts to $50,000, but retains the possibility of issuing waivers (² (Also see "Draft Conflict Of Interest Policy Affects Status Of Many FDA Cmte. Members" - Pink Sheet, 26 Mar, 2007.), p. 7).

The proposal has been criticized by groups, such as the Pharmaceutical Research and Manufacturers of America, that are concerned the policy will exclude essential experts from deliberation.

FDA has acknowledged that a significant fraction of existing advisory committee members would be affected by the proposed policy. Meanwhile, FDAAA requires a 5 percent annual reduction in the number of waivers granted over five years (³ (Also see "FDA Extends Conflict Disclosure Policy To All Advisory Panel Members" - Pink Sheet, 12 Nov, 2007.), p. 8).

Under FDAAA, researchers whose academic institutions receive grants from industry are perceived to have a conflict even if they do not participate in the funded research.

Industry consultant Cindy DiBiasi, a partner at 3D Communications, echoed concerns that the proposed conflict of interest policy would further strain what are shallow pools of qualified candidates in some areas.

"Companies are very good at getting and finding the most experienced people. They want that very valuable insight and that high level of experience. ... So just by the definition of that, you're shrinking the pool, because they're taking a lot of the good people right off the top," DiBiasi said in an interview.

Regarding the conflict of interest rules, DiBiasi said, "While I think their heart is in the right place, I'm a little bit concerned about what that is actually going to result in. I think we're going to be seeing people who are less and less experienced in a drug or a device or an indication having to weigh in on what are often becoming more complicated approvals."

Financial screening is already a major component of FDA's process for selecting committee participants. For permanent members, the agency conducts a general review at the time of appointment. However, because meeting topics are typically unknown ahead of time, it is impossible to preclude future conflicts of interest. Therefore, the agency does a more extensive screening prior to each meeting of both permanent committee members and experts being considered for SGE roles.

FDA does not exclude experts from committee participation simply because of ties to industry, Lutter emphasized.

If there is a review of "a specific drug by one company, the question is, what other products are approved for the same indication, or what other products are commonly used off-label to treat that same disease? And then what companies make those competing products, and what financial links or professional links are there between a committee member and those companies? That is the type of screening we do," he said.

Charles Ganley, director of the Office of Nonprescription Products, recently said the burden on review staff of writing waivers means that participants who require waivers frequently may not stay high on the office's list for members of the OTC drugs committee (⁴ (Also see "FDA Works To Ease “Traumatic” Advisory Committee Process – Ganley" - Pink Sheet, 12 May, 2008.), p. 3).

Lutter said screening everybody for their conflicts of interest, "which internally we refer to as a financial colonoscopy, is fairly important from the perspective of both the number of meetings and the transparency as well as the workload."

"It is extremely resource intensive. ... [It] takes up a lot of time and it creates internal tension between people who want more meetings and greatly respect the need for them and other people who say, 'Well, it is really time-consuming to hold these given the resources that the agency has.' So we have those conversations fairly regularly at a high level."

The agency's current advisory committee focus is on finalizing its several draft guidances, including the proposed conflict of interest policy.

"One of the reasons it has taken so long is we have to look to see that it meshes well with the new provisions in FDAAA," Lutter said.

Until then, the agency will continue to operate under the pre-existing guidance from 2000. FDA also issued a draft conflict of interest disclosure guidance last year.

- Brian Marson, "The Pink Sheet" ([email protected])