FDA response to AHRP procedural questions

From: Cerny, Igor
Sent: Wednesday, January 07, 2004 11:52 AM
Cc: Patel, Anuja; Laughren, Thomas P
Subject: RE: FDA Advisory Committee Meeting: Procedural Concerns

Follow Up Flag: Follow up
Flag Status: Flagged

Dear Ms. Sharav:

Thank you for your email of December 1, 2003, to Thomas Laughren, MD, Team Leader of the Psychiatric Drug Products Group at the Division of Neuropharmacological Drug Products, FDA. I am the Acting Director of FDA’s Center for Drug Evaluation and Research’s (CDER’s) Advisors and Consultants Staff – the group that administers advisory committees for CDER. Since the questions in your December 1 email concern advisory committee processes, Dr. Laughren and I agreed that I should try to respond to the important issues and concerns you raise in your email. It is my hope that my responses will allay the bulk if not all of your concerns.

Let me now try to respond to your questions in the order in which they were presented in your email of December 1, 2003:

AHRP Question #1: Precisely what steps are you taking to prevent conflicts of interest from marring the Feb 2 advisory committee meeting regarding suicidal behaviors in children taking SSRI antidepressants?

FDA response: FDA has implemented a number of changes in its conflict-of-interest (COI) screening process since 1991, adopting a great many of the recommendations in the 1992 Institute of Medicine report. As has been the case for many years, FDA will be applying these revised procedures to this advisory committee meeting. FDA is performing the COI screening of the members as a “particular matter of general applicability” since over a dozen different products and manufacturers may be the subject of the committee discussions. A more detailed explanation of “particular matter of general applicability ” may be found at the following website: which states:

Particular matter of general applicability means a particular matter that is focused on the interests of a discrete and identifiable class of persons, but does not involve specific parties. For example, a guidance document that affects an entire class of products and all similarly situated manufacturers is a matter of general applicability. In addition, the use of a potential product solely as a model or example for general discussion, the results of which will apply to a class of products may be a matter of general applicability.

Because the issue before the committee will not involve the product of one particular manufacturer, but rather involve an entire class of products, it is a particular matter of general applicability. If a special government employee (SGE) has a financial interest in any of the affected products or manufacturers, either a waiver or disqualification is necessary. However, there is a greater likelihood that a waiver will be appropriate than when the matter before the committee affects one specific product or competing product in which the SGE has a financial interest. In other words, there is not the same level of concern about competitive advantage if the outcome will likely similarly affect all members of an entire class of products.

AHRP Question #2: Current FDA procedures on conflicts of interest allow waivers under certain circumstances. Does the FDA intend to give any waivers of conflicts of interest to any panel members?

FDA Response: At the time of this writing, it is not possible to predict whether or not any waivers will be granted or not. Waivers that are granted will follow the procedures outlined in the “Waiver Criteria Document” which is available online at

18 U.S.C. ¤208(b), permits the appointing official to grant waivers under certain circumstances. For waivers granted under 18 U.S.C. 208(b)(3), the standard is that the need for the individual’s services outweighs the potential for a conflict of interest created by the financial interest. Waivers are considered on a case-by-case basis, taking into account the nature of the interest, the magnitude of the financial interest, the relatedness to the matter at issue, and the need for the individual’s participation.

AHRP Question #3: FDA procedures on conflicts of interest require public disclosure of all potential conflicts of interest. Will such disclosure of conflicts of interest be made prior to or at the beginning of the meeting?

[See: Draft Guidance on Disclosure of Conflicts of Interest for Special Government Employees Participating in FDA Product Specific Advisory Committees. Online at: ]

FDA Response: The guidance you cite applies only to those advisory committee meetings at which a particular matter relating to a particular product is discussed (“product specific advisory committees”). This guidance does not apply to advisory committee meetings that provide advice on topics of general applicability. The specifics of any potential conflicts are not disclosed for general matters meetings, or for particular matters of general applicability, but only for product specific meetings. However, regardless of the type of advisory committee meeting, the Executive Secretary of the committee reads the public disclosure statement at the beginning of the meeting. Disclosures of this type typically follow the following format:

The following announcement addresses the issue of conflict of interest with respect to this meeting and is made a part of the record to preclude even the appearance of impropriety at this meeting. The topics to be discussed today will not focus on any particular product or company, but rather may affect all companies that make ____. The conflict of interest statute prohibits special Government employees from participating in matters that could affect their own or their employer’s financial interests. All participants have been screened for interests in the products and companies that could be affected by today’s discussions. In accordance with 18 U.S.C. 208(b)(3), the Food and Drug Administration has granted a full waiver to ______ because the need for his/her services outweighs the potential for a conflict of interest. A copy of the waiver statement may be obtained by submitting a written request to the Freedom of Information Office, HFI-35, 5600 Fishers Lane, Rockville, Maryland, 20857. We would also like to note for the record that ____ is participating in this meeting as the acting Industry Representative, acting on behalf of regulated industry. In the event the discussions involve products or firms not on the agenda for which a FDA participant has a financial interest, the participants are aware of the need to exclude themselves from such involvement and their exclusion will be noted for the record. With respect to all other participants, we ask in the interest of fairness that they address any current or previous financial involvement with any firm whose products they may wish to comment upon.

AHRP Question #4: Inasmuch as the issue of SSRI safety and efficacy has generated conflicting viewpoints, what procedures will you follow to ensure that equal time will be allocated to both sides of the controversy, so that both sides are afforded an equal opportunity to present all their evidence within a reasonable and fair amount of time?

FDA Response: FDA is bringing this controversial topic to an advisory committee forum to ensure that all sides of this issue are heard and discussed. FDA’s goal in selecting outside experts to participate in the meeting has been to seek those who have expertise in adolescent suicidality.

Presentations at the meeting are to be made mostly by FDA personnel, but there will also be presentation by some SGEs. In this process, FDA will strive to ensure that all of its presentations are balanced, and that diverse opinions and viewpoints are presented. There will be sufficient time available for committee members to question each speaker and offer differing viewpoints. FDA will also strive to ensure that sufficient time is allowed for the committee to fully discuss all of the issues at hand so that the opinions of all of its panel members may be heard.

AHRP Question #5: What procedures will you follow to prevent one party from monopolizing the open public time allocation so that one side cannot manipulate the number of speakers who are aligned with groups that receive financial support from one party?

FDA Response: As of this writing, almost 40 presenters have indicated their interest in participating in the open public hearing process. The open public hearing time will likely be expanded somewhat to ensure that as many viewpoints as possible can be heard by the committee. FDA does not filter which parties may or may not speak at the Open Public Hearing. Individuals may be asked to consolidate presentations if there is not sufficient time for all individuals from the same organization to speak separately. In addition, the following statement is read prior to the Open Public Hearing:

Both the Food and Drug Administration (FDA) and the public believe in a transparent process for information gathering and decision-making. To ensure such transparency at the open public hearing session of the advisory committee meeting, FDA believes that it is important to understand the context of an individual’s presentation. For this reason, FDA encourages you, the open public hearing speaker, at the beginning of your written or oral statement, to advise the committee of any financial relationship that you may have with any company or any group that is likely to be impacted by the topic of this meeting. For example, the financial information may include a company’s or a group’s payment of your travel, lodging, or other expenses in connection with your attendance at the meeting. Likewise, FDA encourages you at the beginning of your statement to advise the committee if you do not have any such financial relationships. If you choose not to address this issue of financial relationships at the beginning of your statement, it will not preclude you from speaking.

AHRP Question #6: AHRP requests that each member of the FDA advisory committee disclose whether he / she has been approached or solicited by any of the parties.

FDA Response: All of the committee members will undergo an extensive COI screening process. Committee members who are approached by any of the parties whose products are the subject of this meeting are obligated under law to disclose this. Under these circumstances, they would be ineligible to participate unless granted a waiver in accordance with the “Waiver Criteria Document” referred to in question #2 above. However, as discussed in response to question #3 above, the specifics of any potential conflicts are not disclosed for general matters meetings, or for particular matters of general applicability, but only for product specific meetings. We will inform the public if a general matters waiver has been granted to a committee member. Copies of any waivers granted may be obtained by submitting a written request to the Food and Drug Administration, Office of Management Programs, Division of Freedom of Information, HFI-35, 5600 Fishers Lane, Rockville, MD 20857. Requests may be also be sent via fax to (301) 443-1726.

If you should have any additional questions or would like any more information or clarification, please do not hesitate to contact me at (301) 827-7001 or email me at Cerny@CDER.FDA.GOV.


Igor Cerny, Pharm.D.

Acting Director,

CDER Advisors and Consultants Staff