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Inside Health Policy

New draft guidance expanding conflict of interest disclosure of advisory committee members is continuing to dry up the expert pool, forcing FDA to dramatically step up efforts to recruit experts, FDA officials concede. The agency has also stepped up its process for issuing waivers to the disclosure rules.

Concerns both inside and outside the agency on the challenge of finding scientific experts to serve on advisory panels under the new guidelines appear to have borne out to a degree, Jill Hartzler Warner, acting associate commissioner for special medical programs, told attendees of the Drug Information Association annual meeting this week. She said that the agency has widely broadened its pursuit of potential experts — newly engaging in professional meetings, direct mailings and professional organization listservs to find candidates who will pass the guidance’s threshold.

FDA’s policy challenge is to “balance the need for expert advice with public confidence,” Hartzler Warner told DIA convention attendees. Comments for the conflict of interest draft guidance will be open until the end of the month, Hartzler Warner said.

The disclosure guidance was issued in April, along with a public letter from FDA Commissioner Margaret Hamburg instructing agency staff on when to offer conflict of interest waivers (see FDA Week, April 22). At the time FDA said the guidance brought the agency more in line with financial disclosure standards upheld by academic journals. In addition to requiring the name of the company or institution, FDA now indicates the degree of the financial conflict.

The higher disclosure standard is forcing FDA to find new means of discovering candidates, and the agency has targeted mass communication avenues like online organizational listservs and direct mailings as well as making more efforts at professional meetings.

Hamburg’s April letter to FDA staff highlights how critical this outreach effort is because the principles for deciding when to offer waivers include ensuring justification for the waiver with a search for equally expert advisors without conflicts. Participation for panel members requiring a waiver is needed, Hamburg wrote, with all waivers receiving high-level reviews.

Aside from the outreach efforts, FDA has other transparency work pending, including creating a new website dedicated to making the consumer advocacy role on panels more public, alongside an agency-wide review of the selection process for what projects reach the public domain for feedback, Hartzler Warner said.

A recent initiative focused on the recruitment of consumer representatives included a public meeting held in late April to increase awareness of the recruitment process and the consumer representative role on advisory panels, Hartlzer Warner added.

The agency is also focusing on making the recruitment process more inclusive as the agency looks to find consumer representative members. To wit, FDA staff has expanded the Consumer Representative Nominating Group to include all organizations requesting to be placed on the distribution list.

Part of the focus on disclosure comes from certain provisions in the Food, Drug and Cosmetic Act, namely Sec. 712, which offers new conflict of interest requirements. Those requirements include a mandate for FDA to review an individual’s expertise and financial information to reduce the likelihood that an appointed individual will later need a waiver and requiring all waivers and relevant financial information be publicly disclosed.

The FDC Act also mandated an annual statutory cap on the percentage of conflict of interest waivers that FDA could grant (FDA Week, Feb. 11, 2003).

A recent report measuring conflict of interest and expertise of FDA advisory committees using a sample of 16 meetings and 124 standing advisory committee members found that members with higher measures of expertise are more likely to get waivers and that the “ability to create alternative conflict-free advisory panels is speculative,” FDA said at the DIA conference.

FDA has long aimed to decrease its number of consumer representative vacancies on advisory committees. At the DIA session, FDA noted that the vacancies are still rising, with 215 openings in 2010, after 197 vacancies in 2009 and 168 in 2007. — Seth Freedland (sfreedland@iwpnews.com