By Jill Hartzler Warner, J.D.
One of the strengths of this agency is the breadth of experience and diversity of opinion that exists among the more than 11,000 employees who work on FDA’s behalf around the world.
As with any organization that relies on science to guide its decision-making, robust scientific debate is expected and encouraged. In circumstances where agency staff seeks additional input because of such things as emerging research, the complexity of a new technology, or conflicting scientific data, FDA may turn to outside experts to provide important insights that would help inform our decision-making.
We often ask these experts to advise us on a range of scientific questions – including whether the safety of a drug is properly characterized for patients or if a new device would provide meaningful benefit for patients.
Health care professionals and patients should know that FDA ultimately makes the final decision on all regulatory activities. However, our advisory committee experts, which include patients, provide invaluable insights to the agency on how the broader public will approach a particular product or issue.
There has been a lot of public discussion in recent years about how we engage these outside experts through our advisory committee process. Typically, that discussion centers on how we evaluate committee members’ financial interests and prior involvement with regulated industry.
A lack of understanding about our selection and evaluation process, as well as federally mandated limitations on the type of information we can share publicly, have sometimes resulted in confusion and misunderstanding among the public.
Advisory committees play an important role in FDA’s mandate to promote and protect the public health by allowing the agency to engage independent, technical experts from a variety of disciplines. Our committees are often comprised primarily of individuals working in academia; but also may have representation from private practices, professional and patient groups, regulated industry, and other government agencies.
Before each meeting, FDA screens all advisory committee members who are special government employees or regular government employees for financial conflicts of interest. We ask the members to report to FDA any past and all current involvement or relationships with the products, companies, and issues related to the meeting. Members are required to report all current financial interests that could be affected by the outcome of the advisory committee proceedings and any FDA decision based on the committee’s recommendations. For example, this might include stocks and investments and consulting arrangements. In addition, they report involvements that might present an appearance of a conflict, to the best of their knowledge.
FDA carefully reviews each financial interest reported by each potential committee member and determines whether any would disqualify them from participating. If a member has a financial conflict of interest, they may not participate unless a waiver is granted, allowing them to participate. The agency also reviews other interests that may raise an “appearance” of a conflict and has the discretion to have the member not participate if the circumstances would cause a reasonable person with knowledge of the relevant facts to question his or her impartiality in the matter.
When the FDA decides to grant a waiver to a committee member, we post it to FDA’s website before the meeting, along with the type, nature and magnitude of the waived financial interest. If no financial conflict was determined by the agency, the information submitted by the committee members is considered confidential and by law we do not release that information to the public.
We make clear to our committee members that failure to report relevant known financial interests to FDA prior to participation in an FDA advisory committee meeting is illegal and subject to possible criminal penalties.
I want to specifically address recent reports related to the December 8, 2011 advisory committee meeting that discussed drospirenone-containing oral contraceptives. Based on our review of the members’ reported financial interests, we did not identify any financial interests that would have precluded their participation.
In April 2010, Commissioner Hamburg highlighted a draft guidance for FDA staff and advisory committee members that outlined her desire to create a more consistent and transparent process for disclosing conflict of interest waivers granted by the agency. This is a vision I share.
It is worth noting that since FY2007, the rate of conflict of interest waivers granted by the FDA has been declining sharply. In FY2007, the agency granted waivers for 15 percent of meeting participants; in FY2011, we granted only one percent. How to handle conflicts, while obtaining the best expertise available, is not a challenge unique to FDA. In fact, other government organizations, academic institutions, and peer-reviewed journals are frequently confronted with how to obtain this information from prospective staff and authors as well. Given our interest in this area, we have been working closely with outside stakeholders and theInstituteofMedicineto explore whether a common financial disclosure form or website could be created making it easier for individuals to report their financial interests.
I’m personally excited about what an approach like this could mean for the agency. In its design, this approach could allow individuals to report information in a standard and consistent way, serving as a resource for agencies like FDA looking to receive reliable information while at the same time reducing burden on our experts. We are also exploring the administrative steps in review of conflict of interest screening and evaluating whether the process can be streamlined.
I want to personally thank each and every one of the past and current members of FDA’s 50 advisory committees and panels. They have been generous with their time and expertise and have played an instrumental role in allowing the agency to fulfill its commitment to protecting the public health.
Jill Hartzler Warner, J.D., is FDA’s Acting Associate Commissioner for Special Medical Programs