We’re a little late in reporting this, but on July 26, the House passed a bill to improve the transparency and accountability of federal advisory committees. Among other things, the bill, H.R. 1320, would:

• Ban agencies from applying “political litmus tests” when selecting committee members;
• Require agencies to designate members as either representatives of a particular viewpoint or experts consulted to provide unconflicted scientific or technical advice;
• Apply stricter conflict of interest and disclosure requirements to members designated as experts;
• Require agencies to post on their websites information about committees and committee meetings, including transcripts and audio or video recordings of meetings; and
• Provide the public with an opportunity to comment on potential committee members before they are selected. 

Congress, presidents, and agency heads charter advisory committees for a number of reasons. Sometimes, advisory committees are to supplement an agency’s expertise, like when the EPA asks outside scientists to assess the effects of a pollutant on human health. Other times, they are to attain practical advice and opinions from stakeholders, like when the Department of the Interior consults with farmers, environmental groups, and/or Native American tribes on land planning issues.

In recent years, advisory committees have tended to make headlines not for the sage wisdom they provide but for the controversies they stoke when conflicts of interest or accusations of bias arise. H.R. 1320 won’t eliminate these issues, but it should limit them. At the very least, it will give the public a clearer look into the formation and proceedings of advisory committees and provide citizens and advocates with the tools to hold accountable both committees and the agencies that manage them.

The bill passed with bipartisan support; 27 Republicans joined 223 Democrats in voting “yea.” The bill now joins the queue of items awaiting action in the Senate, a.k.a. the Island of Misfit Bills. A similar bill passed the House in June 2008, during the 110th Congress, only to die in the Senate.

The Food and Drug Administration (FDA) is tweaking the way it treats advisory committee members who have financial conflicts of interest. FDA will require more detailed information on the financial interests of members who have been granted waivers to serve on committees despite a potential conflict, according to draft guidance released Wednesday.

FDA uses advisory committee to “provide independent, expert advice on scientific, technical, and policy matters related to the development and evaluation of products regulated by FDA.” Generally, persons with a financial interest in a product or industry in question cannot serve on committees. But, FDA may grant a waiver to permit conflicted individuals to serve.

The most significant change in the draft guidance, it appears to me, is the requirement that panel members with conflicts of interest identify the name of the firm or organization to which they are financially tied. Previously, the FDA only disclosed the general category, i.e. competitor or shareholder.

The change should instill greater accountability into committee proceedings. The public will now be armed with more information to judge whether a panelists’ views are unbiased by a financial interest.

The draft guidance is open for public comment until June 21. FDA last revised its guidelines on committee members and conflicts of interest in August 2008. This week’s guidance would make only minor changes to the 2008 guidance, which critics accused of being weak.

Accompanying the guidance, FDA Commissioner Margaret Hamburg sent a letter to senior agency officials providing her perspective on the conflict of interest issue. In the letter, she said committees “should search far and wide for experts who have the requisite knowledge without conflicts of interest” but added that in certain situations conflicts are inevitable, in her view.

When a conflict does arise, Hamburg identified three criteria for her staff to apply when deciding whether a waiver is appropriate:

1. The nature of the conflict, writing that, “Not all conflicts are created equal;”
2. The committee’s charge, asserting that conflicts are less problematic for broad, issue-based committees than for product-specific decisions; and
3. The process for searching for unconflicted members and the justification of the need for the conflicted member, which staff must explain. 

Twenty groups, including OMB Watch, have sent a letter calling on Congress to include accountability and transparency provisions in any health care reform legislation. Specifically, the groups focused on federal advisory committees – panels that will provide critical advice on health care issues if legislation is passed. The groups represent a wide variety of public interest issues.

Current bills under consideration would create several new advisory committees. Although most of these committees would be subject to the Federal Advisory Committee Act, that law is too weak to provide the public with adequate opportunities to monitor and participate in the health care policy debate once it moves out of Congress and into federal agencies.

The letter, sent Nov. 3 to House and Senate leadership and key lawmakers crafting reform legislation, underscores the important role these advisory committees will play and calls for specific transparency and accountability provisions to be included in legislation:

Because these advisory panels will play major roles on issues ranging from immunization practices and clinical research to health care financing and the development of the health care labor force, we urge you to ensure that members of these panels perform their duties with full transparency and free of financial conflicts of interest.

The American public will be ill-served if these advisory committees operate behind closed doors and are influenced by members with financial ties to special interests with a stake in their deliberations.

At a minimum, all advisory panels created by any final health care law should:

• Require that all information about each advisory panel, including a full audio or video record of each panel meeting, is accessible via the Internet;
• Actively seek out advisory panel members without conflicts of interest;
• Assess financial conflicts of interest, and strive to name only non-conflicted experts to advisory committees;
• When conflicts are unavoidable, require that any waivers given to a conflicted advisory board member and the reasons for granting the waiver are part of the public record; and,
• Specifically require disclosure of the names and backgrounds of each member, and whether they are serving as experts or to represent particular constituencies. 

To read the entire letter, click here.

Image by Flickr user zizzybaloobah, used under a Creative Commons license.