Comments by Larry D. Sasich, Pharm.D., M.P.H and Sidney M. Wolfe, M.D.
Public Citizen Health Research Group
On Disclosure of Conflicts of Interest for Special Government Employees Participating in FDA Product Specific Advisory Committees; Draft Guidance
One major purpose of the timely disclosure of financial conflict of interest information concerning FDA advisory committee members is to allow for an independent public assessment of decision making by FDA officials about granting waivers. Therefore the timeliness and the completeness of the disclosure of such information concerning all advisory committee members is of critical importance.
1. Timing of disclosure
Financial conflict of interest disclosure should be available to the public at least two weeks prior to an advisory committee meeting. Section 120 of the Food and Drug Administration Modernization Act (FDAMA) provides that a waiver may be granted upon public disclosure of a conflict of interest. In accordance with the statute, a decision to grant (or not grant) a waiver should be posted on the internet promptly after the decision is made, and certainly well before the meeting. Because the decision to grant a waiver must necessarily precede the meeting, and in most instances will do so by at least several weeks, the FDA can easily comply with the statutory directive.
There is no reason why, upon the decision by the FDA for or against granting a waiver, a decision which must significantly precede the meeting in order for travel plans to be made (or cancelled), the details of the conflict of interest of all advisory committee members can not be posted on the internet.
2. Disclosure for the past two years
An independent assessment of the nature and extent of a potential conflict of interest by the public involves not only the amount of fees paid by a sponsor, or the sponsor s competitor, to an advisory committee member but the length of time that the financial arrangement has existed. Disclosure of only one year of information is not sufficient to place a potential conflict in perspective. There should be at least two years of information disclosed to the public.
3. Naming of competitors
In the highly competitive pharmaceutical marketplace the names of companies and products that are on the market, or in development, that would compete with a product under review by an advisory committee are important in the understanding of the nature of a conflict and the degree to which it can be expected to influence the recommendation of an advisory committee member. Although not stated in the guidance, the burden should be on the FDA to inform each advisory committee member, sufficiently in advance of the meeting, of the names of all companies with competing products approved or in the pipeline – so a detailed financial conflict of interest response for each can be provided by the advisory committee member.
In the case when the competing product has not yet been approved by the FDA but is in the regulatory pipeline, it may be legitimate not to disclose the name of the company and product but to have full disclosure of the financial conflict of interest. However, if the competing product has been marketed, disclosure of the name of the company with which the advisory committee has a conflict of interest is essential for a more meaningful evaluation of the potential impact.
For example, at the start of the January 17, 2002 FDA Pulmonary and Allergy Drugs Advisory Committee, Committee Member Dr. Apter was granted a waiver although she owned stock in two companies with competing products. In one company, the stock was valued at between $5001 and $25,000 dollars and, for the other, between $50,001 and $100,000. With as much as a twenty-fold difference between the value of the stocks in the two companies with competing products, the identity of these companies, assuming the competing products are marketed, is essential in order to more properly evaluate the nature of her participation in discussion and votes on the product up for discussion at that meeting.
Although implied in the guidance, we want to make sure that there will be a separate and full accounting of the financial conflicts of interest an advisory committee member has with each company that markets a competing product or has a competing product in development.
4. Provision of data on members excluded from a specific meeting because of conflict of interest
To permit an adequate evaluation of the FDA decisions concerning conflict of interest, the details of those excluded from participation in a specific meeting must also be disclosed. For example, at the start of the same January 17, 2002 advisory committee meeting mentioned above, the FDA announced that two members, because of their “reported interests,” were excluded from all matters concerning the drug being discussed at the meeting and therefore that they did not participate in the meeting. However, when the conflict of interest statement was read at the start of the meeting, no details were given about the nature of the financial conflicts of interest that had led to the exclusion of Drs. Gross and Niederman. As mentioned above, since the decision to exclude them had been made well in advance of the meeting, the facts upon which such exclusion was made should have been disclosed to the public at least two weeks before the meeting.
5. Disclosure of advisory committee members who resign from a committee because of financial conflict of interest
We are not aware of whether any member of any FDA advisory committee has resigned since this disclosure policy was instituted. If any member has resigned or does resign in the future because of a financial conflict of interest, the fact of the resignation and the conflict of interest information that precipitated the resignation should be made public two weeks before the advisory committee meeting and read into the record at the meeting.
6. Will the guidance apply to all Centers within the agency?
Since FDAMA implies that all centers in the FDA are affected by this disclosure policy, is it currently in effect for all centers?
7. Advisory Committee Meetings that are not Product-Specific
Although the Guidance includes “Product Specific” in its title, conflicts of interest may also influence recommendations made during advisory committee meetings providing advice on topics of general applicability. For example, the upcoming Oncologic Drugs Advisory Committee meeting to discuss investigators conflicts of interest in pediatric oncology trials will address an important non product-specific topic, the discussion of which may be greatly influenced by whether the members personally have a significant financial conflict of interest.
Thus, for all meetings, financial conflict of interest information needs to be disclosed in advance. The FDAMA section that precipitated the guidance is not limited to product-specific advisory committee meetings and thus the guidance imposes a limitation not supported by the statute.