Food and Drug Administration Advisory Committees (1992) / Chapter Skim
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6 Ensuring Committee Integrity
6 Ensuring Committee Integrity
Pages 127-172
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From page 127... ...
The topic is a candidate for further attention in connection with the work of the FDA advisory committees, just as it is now receiving extensive scrutiny and debate among poli~makers and academic scientists who confront it in other contexts. Potential financial conflict of interest and intellectual bias are obviously critical matters for the Food and Drug Administration and for the public.
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From page 128... ...
The goals of any system for mediating these tensions must be to protect the integrity of the FDA's decisions and at the same time to allow the agent y access to essential expertise. The IOM Committee is concerned that the current system for managing potential financial conflicts of interest, as now administered, may be jeopardizing the latter goal without significantly advancing the first.
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From page 129... ...
In the committee's judgment, however, the core of the problem, or at least the portion on which thoughtful recommendations might make an immediate contribution, is internal to the FDA and the department. The problem resides in the system for identifying potential financial conflicts, for the agengy's determining whether to seek a waiver (which is specifically provided for in the governing law)
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From page 130... ...
prohibits (i.e., makes criminal) a government employee from participating "personally and substantially" in any "particular matters in which, to his/her knowledge, "he, his spouse, minor child, general partner, organization $ As defined in the FDA Staff Manual Guide 3118.6, April 18, 1986, this category includes Anyone who is retained, designated, appointed or employed to perform services with or without compensation for a period not to succeed 130 days during any period of 365 days whether on a fulltime or intermittent basis."
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From page 131... ...
. through decision, approval, disapproval, recommendation, the rendering of advice, investigation, or otherwise, in a judicial or other proceeding, application, request for a ruling or other determination, contract, claim, controversy, charge, accusation, arrest, or other particular matter in which, to his knowledge, he, his spouse, minor child, general partner, organization in which he is sewing as officer, director, trustee, general partner or employee, or any person or organization with whom he is negotiating or has any arrangement concerning prospective employment, has a financial interest~hall be subject to the penalties set forth in section 216 of this title."
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From page 132... ...
, from Prohibits any federal officer or employee from participating personally 1978 Ethics in and substantially in a particular matter in which, to his/her knowledge Government Act the employee, hislher spouse, minor child, or general partner, an organization in which he/she is sending as an officer, director, trustee, general partner, or employee, or a person or organization with which he/she is negotiating for or has an arrangement concerning prospective employment has a financial interest. Types of Waivem Test for Granting Waiver Current Status 20~b)
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From page 133... ...
However, under DHHS polisher, any exception granted under (but) does require approval by the Office of the HHS Special Counsel for Ethics.
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From page 134... ...
Under this provision, the appointing official is allowed to grant a waiver for a committee member, who would otherwise be disqualified from discussing a particular matter, i.e., a specific agenda item, to participate in deliberations on that matter without violating the law. The exercise of this authority calls for a judgment in writing "that the need for the individual's services outweighs the potential for a conflict of interest created by the financial
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From page 135... ...
; his authority under the Executive Order requires consultation with the OGE. Thus, the impact of this legal regime on the FDA advisory committee members, and on the advisory committee system, will be a function of three factors: (1)
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From page 136... ...
Each committee agenda item, therefore, presents an occasion for evaluating a member's potential conflict-of-interest. Consequently, agency and departmental administration of conflict~f~nterest laws focuses on the second stage, when meeting agendas are known and the Particular matters to come before the committee have been identified.
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From page 137... ...
Once a nominee for committee membership has been tentatively approved at the center level, a member of the FDA staff, usually the committee executive secretary or a member of the advisory committee management stay, contacts the individual by telephone to determine his or her availability and to identifier any factors that might preclude appointment or diminish the individual's effectiveness. In all three centers, this initial conversation also includes rescreening questions that solicit information about the nominee's financial interests and relationships.
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From page 138... ...
the FDA Staff Manual Guide, Section 3118.2, part 6, provides general instructions for the screening of individuals for potential financial conflicts, but it offers no concrete guidance regarding acceptable types or magnitudes of financial relationships. The usual results of the FDA's "financial interest review" at the appointment stage are, first, to confirm the nomination, and second, to create a record of the member's potentially disqualifying financial interests.
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From page 139... ...
A RAPIDLY CHANGING SYSTEM Throughout the 1980s the system for identifying potential conflicts of advisory committee members and, in appropriate cases, processing waivers (generally based on subsection (but)
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From page 140... ...
the FDA's criteria and procedures for identifying potential financial conflicts and processing waivers caught the attention not only of the Commissioner and his advisers but of other officials inside and outside the agency. Scrutiny was also heightened because these controversial cases occurred in a very compressed period of time, from late 1991 through mid-1992.
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From page 141... ...
The objective was to consider the adverse reaction data to determine the existence of causality between these drugs and suicidal or other violent behavior. Although it was apparently not the FDA's plan to invite discussion of specific product submissions or to solicit advice on remedial actions that would impact manufacturers of Prozac or other antidepressant drugs, the agency realized that the committee could potentially recommend action that might bear on the use of these drugs.
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From page 142... ...
At the time of the September 1991 meeting, the FDA program staffs were operating under the old conflict-of-interest statutes, ignoring subsection (by, which had been added to the law by the Ethics Reform Act of 1989. The facts that the waiver process operated without legal oversight and was oblivious to the latest changes in the conflict-of-interest law suggested that the process was in severe need of scrutiny.
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From page 143... ...
The waiver review and approval process now included the CDRH, the DEPI, the FDA Chief Counsel's Office, the Commissioner, and the OSCE for the department. The agency was well aware that the subject of silicone breast implants was attracting intense public scruity.
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From page 144... ...
After his term expired, the former chair of CDER's Arthritis Drugs Advisory Committee continued as a consultant to the Pilot Drug Evaluation Staff. In that capacity he sewed as the primary clinical reviewer of the metho~ysporalen/photophoresis NDA mentioned above.
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From page 145... ...
No waivers were sought for the other parts of the meeting, in which they participated. This reveals a heightened sensitivity to conflict of interest within the FDN Largely bemuse of this increased sensitivity, the CBER division elected not to seek waivers for the three committee members.
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From page 146... ...
By the time of this meeting, the FDA's system for processing waivers had expanded to included this CBER program area, the DEPI, the FDA Chief Counsel's Office, the DHHS Office of Special Counsel, the Office of Government Ethics, and finally, the Center Director's Office. The process had become both contentious and time consuming.
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From page 147... ...
208 waiver must address the SGE's university affiliations." This was the first written notice that the centers received regarding this change in policy. Consequently, on April 9, one day before the scheduled Dermatologic Committee meeting, the CDER committee management office was faced with the task of preparing 11 (boy)
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From page 148... ...
6. On Friday, May 8, CDRH's committee management office was informed by the DHHS Office of the Special Counsel for Ethics that no waiver would be allowed for the member who had been assigned as lead renewer for the atherectomy catheter.
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From page 149... ...
The issue of waivers for committee members involved in research on competing technologies still presents problems for the FDA The preceding cases illustrate several of the confusing and frustrating events that have occurred within the centers' respective committee management offices between the period from September 1991 and June 1992. The rapidly escalating scrutiny of potential conflicts, the number of parties involved in the waiver process, the expanding criteria for identii ying potential conflicts, and the zeal with which these criteria were applied combined to wreak havoc in the FDA's advisory committee operations.
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From page 150... ...
Additionally, the "need for the members portion of the waiver is being reviewed more cntically; in the past, statements to the effect that a member was a preeminent scientist and a member of the committee generally sufficed as a rationale. A very serious flaw in the current waiver process is the lack of relevant written standards, at any level, for granting waivers, i.e., for ranking potential conflicts, for deciding whether a member's importance outweighs any risk of conflict, or for explaining decisions to grant (or deny)
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From page 151... ...
ENSURING COMM[rlbE INIEGRlTY 151
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From page 152... ...
These forces included the heightened concern, within the administration and in Congress, over conflicts of interest involving federal employees; President Bush's decision to centralize in the OGE oversight of the waiver process for the entire government; Secretary Sullivan's decision to create a Special Counsel for Ethics responsible for reviewing all waivers granted within the department; the ripple effects of Dr. Kessler's own demands that the FDA officials and procedures should be, and should be seen to be, free from any hint of conflict of interest; a revived appreciation that the carelessness ~ identifying conflicts and granting waivers might not only jeopardize agency decisions but leave committee members exposed to criminal prosecution; and the reintroduction of lawyers, who were themselves confronting issues for the first time, into a system that had previously displayed an amateur understanding of the law.
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From page 153... ...
Waiver Preparation and Review The FDA's centers will remain responsible for the initial screening of advisory committee members, for determining whether a member confronts a potential conflict relative to an agenda item, for deciding whether to recommend a waiver to the Commissioner, for preparing waiver requests, and for obtaining information from committee members. The OSCE will have final authority for the agency and the department to determine whether a member's participation~bsent a waiver-would violate the law, i.e., whether a potential conflict of interest exists.
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From page 154... ...
Part I will be a straight forward recitation that the Commissioner or Deputy Commissioner has granted a waiver for a committee member to participate in the discussion of an agenda item with respect to which he/she would otherwise have a conflict. Part II will consist of a more detailed explanation of the circumstances that give rise to the potential conflict and the reasons why the center (and agency)
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From page 155... ...
RECOMMENDATIONS ON FINANCIAL CONVICT OF INTEREST The IOM committee believes that it is essential that the members of technical advisory committees be impartial and objective and not compromised by financial conflicts of interest. To achieve these ends, the IOM committee has addressed the standards and procedures for controlling convict of interest.
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From page 156... ...
On the other hand, because the interpretation of a prohibited interest is already extremely broad, and because potential conflicts cannot be identified before meeting agendas are set, vigorous pursuit of this approach might disqualify valuable members and produce no gain in integnty. Third, the FDA, working with the OSCE, could formulate and codify criteria for granting 208(b)
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From page 157... ...
Regarding the latter point, we believe that committee membership alone should not be taken automatically as a decision measure of a member's importance. Of immediate importance is the need to Warier the criteria for dealing with potential conflicts arising from institutional or employer financial interests, research grants and contracts to committee members, and member involvement with competing products and technologies.
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From page 158... ...
Seventh, the FDA must also initiate and maintain a formal orientation program for advisory committee members. Individual members should clearly understand the laws that govern financial conflict-of-interest and the justifications for granting waivers.
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From page 159... ...
The IOM committee recommends to the President that Executive Order 12674 be amended to remove from the OGE the responsibility for caseby~case renew of advisor committee member waiver requests, that authority for such case-by~case review be delegated to the departments, and that the OGE be directed to focus on agencies' policies and procedures. INTELLECTUAL BIAS This chapter thus far has focused on the methods for protecting committee deliberations against just one threat to impartiality the possibility that committee members will modify their advice because of the prospect of personal or employer financial gain or loss.
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From page 160... ...
For convenience we have termed this potential erect unintellectual biases which is meant to distinguish the problem at hand from financial conflict of interest. Too frequently, we think, both members and observers of the scientific community apply the term Conflict of interests to the problem of intellectual bias, which is more complex and elusive than the sorts of financial conflicts we have heretofore been discussing.
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From page 161... ...
A second is that the widespread belief that some committee members are, if only rarely, immune to persuasion by evidence would surely erode public confidence in a mechanism the FDA has devised precisely to enhance confidence in its own decisions. We do not consider intellectual bias to be a common problem among members of the FDA advisory committees.
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From page 162... ...
On the other hand, there is some disadvantage to creating too large a set of roles at committee meetings to accommodate various perceived levels of partiality. A sensible rule of thumb might recognize jUSt three roles for committee members in the case of intellectual bias: (a)
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From page 163... ...
The TOM committee recommends that the FDA develop criteria and procedures for identifying potential intellectual bias of advisory committee members and protecting the objectivity and impartiality of advisory committees. The committee recommends that the agency routinely request information about research interests and publicly stated positions on scientific issues from advisory committee members.
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From page 164... ...
164 FDA ADP7SORY COMMITTEES NOTES 1. Berg, Richard K, Con~ct-of-Inta~est ~quiranents for Federal Advisory Committees, Report to the Administrative Conference of the United States ~lashington, D.C, May 1989)
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From page 165... ...
It is this authontr on which the FDA now exclusively relies in deciding whether to allow members with potential financial conflicts to participate in committee deliberations on a particular matter. The IOM committee report itself does not offer concrete guidance on how this might be done.
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From page 166... ...
The recent history of the development, review, and approval of (bog) waiver requests for members of the FDA advisory committees, recounted in the IOM committee report, illustrates the consequences of the failure to develop general criteria for approving such requests.
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From page 167... ...
The IOM committee found signs that officials in the FDA and OSCE recognize the need to regularize the waiver review process and reach agreement on the treatment of certain categories of potential conflicts. The committee's recommendation is essentially that this effort be extended and given priority.
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From page 168... ...
The attitude that committee membership~nother live body eligible to voters all that is necessary to convince center personnel that an individual member, despite a significant potential conflict, is absolutely crucial to deliberations cannot inspire confidence that the FDA is exercising the sort of discriminating judgment that the law seems to contemplate.
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From page 169... ...
This sort of waiver does not require an assessment of the employee's, e.g., the committee member's, importance to committee deliberations. Thus the effort to identity types of financial interest whose potential influence is so improbable that mere membership can be considered outweighing is a logical prelude to the exercise that the OGE must eventually undertake to implement (b)
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From page 171... ...
It would be a crude generalization, to be sure, but crude generalizations will be necessary to develop a framework that can guide and, which is the ultimate goal, simplify and thus expedite-review of individual waiver requests. Within the category of personal interests, individual research grants are apparently a common source of presumptive disqualification.
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From page 172... ...
The suggestion made here is that some interests can be classified as so unlikely to threaten impartiality that selection for committee membership can be taken as sufficient evidence of importance to offset the remote nsL But there may be few such interests, and they are likely to be an employer's rather than personal or family interests. Thus, in evaluating many waivers attention must be given to a member's Importance to committee deliberations.
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