Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Posted 01 April 2014 | By Alexander Gaffney, RAC,
A new guidance document published by the US Food and Drug Administration (FDA) is intended to clarify how financial information about members of its advisory committees should be made available to the public.
FDA's advisory committees are used regularly to make recommendations regarding regulatory topics, such as the approval of a new drug product or the need for a new regulatory approach. While their recommendations are not binding on the agency, they are nevertheless seen as highly influential.
And that influence has led to problems for FDA in the past.
For example, The Wall Street Journal reported in January 2012 that at least three members of an advisory board assessing the safety of four of Bayer AG's birth control products had financial ties to the company.
Information about financial ties can be extremely difficult to track down, as FDA explained at the time that it was "prohibited from giving the public any information contained in a financial disclosure," but that FDA conducted financial reviews on its own.
The uproar prompted FDA to issue a rare public statement on its blog clarifying that financial information submitted by committee members is confidential, but that it was in the process of creating a "more consistent and transparent process for disclosing conflict of interest waivers granted by the agency."
"Given our interest in this area, we have been working closely with outside stakeholders and the Institute of Medicine (IOM) to explore whether a common financial disclosure form or website could be created, making it easier for individuals to report their financial interests," concluded Jill Hartzler, then FDA's acting associate commissioner for special medical programs.
Critics, such as the public advocacy group Project on Government Oversight (POGO), have meanwhile called for complete transparency when it comes to conflicts of interest.
So what can-and what should-FDA release to the public regarding the financial interests and potential conflicts of interests of its advisory committee members?
In March 2012, FDA released a draft guidance intended to address that very question-a guidance it has now released in final form.
Public Availability of Advisory Committee Members' Financial Interest Information and Waivers, released on 31 March 2014, is specifically geared toward so-called Special Government Employees (SGEs), the technical name for advisory committee members who are not members of FDA or other government agencies.
"FDA implements a rigorous process for soliciting and vetting candidates for advisory committee meetings to minimize any potential for financial conflicts of interest," FDA explains in the guidance. "In preparation for advisory committee meetings involving particular matters, SGEs invited to participate in the meetings are required to report to FDA any financial interests related to the subject matter of the advisory committee meeting."
Those disclosures, made in Confidential Financial Disclosure Reports (CFDRs) to FDA, are only one component of what FDA says it reviews. It also investigates the interests of a SGE's immediate family, the financial interests of known business associates, and current or prospective employers.
Still, even if a potential advisory board member does have conflicts of interest, they may be given a waiver to participate anyway. That's because FDA has long found it difficult to staff advisory committees with qualified staff, and some world-class experts may be involved with consulting with nearly every product in development in their field of expertise (for example, a rare disease).
Waivers, though, are not treated the same as normal financial disclosures, FDA explains in its guidance document.
"FDA is directed to disclose on its website the type, nature, and magnitude of the financial interests of each advisory committee member who has received a waiver under 18 U.S.C. § 208 and the reasons for granting each waiver prior to the advisory committee meeting, including, as appropriate, the public health interest in having the expertise of the member with respect to the particular matter."
But FDA's guidance does concede that FDA would rather have more transparency in its advisory committee process. FDA said it intends to make advisory committee meeting participation contingent upon a SGE's "acknowledgement of FDA's intention to publicly disclose" information about the type, nature and magnitude of any waived financial interests.
That information will be made available using a template found in its guidance, and will be made available at least 15 days in advance of the relevant advisory committee meeting (unless FDA is not made aware of the conflicts until shortly before the meeting).
In addition, FDA says it plans to post a roster of all advisory committee members expected to attend a specific advisory committee meeting, which should allow at least limited time for members of the public or industry to conduct their own conflict of interest investigations.
Public Availability of Advisory Committee Members' Financial Interest Information and Waivers (FR)
Tags: SGE, Waiver, AdComm, Latest News, advisory committee, guidance
Regulatory Focus newsletters
All the biggest regulatory news and happenings.