Let There Be Light: The FDA's Surprising New Policy

Information about experts who advise the Food and Drug Administration will soon be posted online, under a new policy just announced by the agency. They are the experts—members of the FDA’s advisory committees—who advise the agency on the safety and efficacy of proposed new drugs and devices.

The crux of the announced change is disclosure of information about the qualifications, background, and financial ties of members of the agency’s advisory committees.

For years, members of the public have used the Freedom of Information Act to request information about advisory committee members—information that the committee members provide in their curricula vitae (CVs). The FDA, when responding to these requests, has redacted certain information about committee members’ professional relationships, industry grants, and other information. But that is about to change.

The FDA now has a brand-new policy (“Advisory Committee Nominations; Modification To Process for Collecting and Posting Curricula Vitae”), published in the Federal Register on February 6:

The Food and Drug Administration . . . is modifying the process by which we collect and post curricula vitae (CVs) of advisory committee members so that the CVs will be posted to our Web site without removing or redacting any information. Posting CVs without removing or redacting any information will increase the transparency of FDA’s selection of officials who serve on advisory committees, and will ensure greater public access to the qualifications of advisory committee members on an ongoing basis. . . . [T]his modified collection and posting process will conserve FDA resources because FDA personnel will no longer be responsible for reviewing and redacting the CVs.

For at least a decade, several organizations have pushed for greater disclosure of this information. These organizations include Public Citizen, Project on Government Oversight (POGO), Union of Concerned Scientists, the Center for Science in the Public Interest, and the National Center for Health Research.

These organizations’ efforts have focused on two different documents that each advisory committee member provides to the FDA: (a) the member’s curriculum vitae (which is the subject of the FDA’s announcement in the Federal Register of February 6), and (b) the member’s completed FDA 3410 financial disclosure form (which we discuss later in this blog post). By the time the advisory committee meets, FDA officials have examined both documents.

Conflict of interest concerns

Information about the financial ties of advisory committee members is scattered across university websites, journal articles, and other sources. From this information, journalists and advocacy groups have pieced together a troubling picture of industry influence over FDA advisory committees.

For instance, the Washington Monthlyreported in 2012:

In a decision that helped ensure the continued presence of these drugs on American pharmacy shelves, the committee concluded by a four‑vote margin that the benefits of drugs with drospirenone outweigh the risks. However, an investigation by the Washington Monthly and the British medical journal BMJ has found that at least four members of the committee have either done work for the drugs’ manufacturers or licensees or received research funding from them. The FDA made none of those financial ties public.

Two years later, in a separate investigation of FDA advisory committees (also called “panels”), the Wall Street Journalfound:

In panels evaluating devices involved in cardiology, orthopedics and gynecology from 2012 through 2014, a third of 122 members had received compensation—such as money, research grants or travel and food—from medical‑device companies, an examination of databases shows. Nearly 10% of the FDA advisers received something of value from the specific company whose product they were evaluating. The FDA disclosed roughly 1% of these corporate connections.

How the change in FDA’s disclosure policy occurred

The FDA has been posting committee members’ CVs online, but with certain information redacted under the theory that this information is exempt from disclosure under the Freedom of Information Act (FOIA). This law allows an agency to withhold information to protect personal privacy and to withhold confidential commercial information.

In May 2014, Public Citizen filed a FOIA request for unredacted copies of the CVs of many members of FDA advisory committees.

The FDA failed to comply with this request. This led Public Citizen to file a lawsuit, in April 2016, asking a U.S. District Court to force the FDA (and its parent agency, the Department of Health and Human Services, DHHS) to comply with the FOIA request. Among other things, Public Citizen asserted that information included in advisory committee members’ CVs is not credibly deemed “private” or “confidential”; Public Citizen argued that the public had a strong interest in the information in order to better evaluate the work of the advisory committees.

“Confidential information does not appear on documents crafted for the express purpose of sharing with other people,” Rachel Clattenburg, the lead Public Citizen attorney on the case, said at the time. “The redactions are unjustified and show that the FDA has wasted considerable time going through CVs to black out information. We worry that the FDA’s treatment of advisory committee member CVs is an indication that the agency favors secrecy over disclosure.”

Then, on January 19, 2017, the three parties (Public Citizen, plaintiff, and FDA and DHHS, defendants) took a step toward resolution of the lawsuit. They reached an agreement that involves, among other things, “an anticipated change in policy by the FDA,” and the case is now stayed to allow for implementation of the policy change.

FDA has started the process of implementing this change in policy. In the Federal Register of February 6, 2017, the FDA announced its new policy (dated February 1) for collecting and posting the CVs of advisory committee members. (This complicated story is described, with links to the relevant documents, on Public Citizen’s website.)

Likely benefits of FDA’s new policy

Under the new policy, the public will have access to advisory committee members’ full CVs.

The new policy is long overdue. The FDA could easily have reached the same endpoint without stonewalling for a decade or more and without battling in court for almost a year.

Under the FDA’s new policy, the public will be able to better evaluate advisory committee members’ qualifications and perspectives. We also believe that the FDA will make better decisions, overall, on the safety and effectiveness of drugs and medical devices.

Full public disclosure of CVs: An excellent start

The CV is only one of two documents that advisory committee members must send to the FDA before a committee meeting. The other document is the completed FDA 3410 form (“Confidential Financial Disclosure Report for Special Government Employees”).

Advisory committee members enter, into this form, specific information about their investments, consultancies, and other financial arrangements—including, but not limited to those that may create a conflict of interest. The information in the forms is strictly confidential. None of it is obtainable through a FOIA request.

Earlier in the blog post we described two troubling examples of industry influence over FDA advisory committees—one published in Washington Monthly, the other in the Wall Street Journal. POGO cited these examples and others in letters to former FDA Commissioner Margaret Hamburg and other agency officials (in January 2012, November 2013, and January 2015). We commented on the benefits of full public disclosure of committee members’ financial arrangements—those described in the FDA 3410 form. We said that many members of advisory committees would welcome this kind of disclosure, since the same or very similar information is already being made public in medical journals, on the websites of academic institutions, and in other ways.

We urged that some way be found to make public the contents of the 3410 forms. “We believe the mood may be right in the medical and scientific community for the voluntary disclosure of this information,” we wrote. There may be legal barriers to the public disclosure of information in the 3410 form, but the FDA could press for a change. Full public disclosure should be the goal. We believe that the current level of disclosure is still a long way from that goal.

The announcement by the FDA in the February 6 Federal Register focuses exclusively on the posting of unredacted CVs. It contains no mention of the FDA 3410 form. Nonetheless, the FDA’s new policy is a step in the right direction.

Will the policy survive?

While the new policy is slated to go into effect on March 8, its eventual fate is unknown. The Secretary of HHS, Tom Price, was confirmed on February 10—after the policy was published. An FDA Commissioner has yet to be nominated and confirmed. Moreover, the new policy requires approval by the administration’s Office of Management and Budget. To date, OMB has taken no public action.

The new policy of the FDA has two major benefits—greater transparency of government actions and conservation of limited FDA resources. The policy is a win for both the public and the FDA.