FDA Updates Conflict-of-Interest Guidelines for Advisory Panel Members
On Wednesday, FDA issued draft guidance that would require agency advisory committee members who obtain a conflict-of-interest waiver to disclose the names of companies and institutions with which they worked, CQ HealthBeat reports.
Previous guidelines only required experts' conflict-of-interest waivers to describe the type and magnitude of an individual's financial ties to a company or institution and be posted online.
FDA often has difficulty finding experts to consult on certain highly specialized regulatory issues, according to CQ HealthBeat. The agency caps the proportion of advisory members with conflicts of interest at 13% and currently just 5% have such conflicts. About one-third of the 618 positions on FDA's advisory committees are unfilled.
FDA Commissioner Margaret Hamburg on Wednesday released a letter listing three ways in which the agency can "minimize concerns when needed experts may have a conflict of interest." They call for:
- Considering the nature of the conflict of interest and appropriately weighing its effect;
- Considering the type of expert advice the agency is seeking;
- Justifying waiver recommendations, including a description of the search for other experts without conflicts of interest and an explanation for why an expert's participation is essential (Reichard, CQ HealthBeat, 4/21).
Physician Groups Release New Conflict of Interest Code
In related news, the Council of Medical Specialty Societies has released a new ethics code in an attempt to limit drugmakers' and device makers' influence over patient care, the AP/Miami Herald reports.
The council is made up of 650,000 members from 32 medical societies, including the American College of Physicians and the American College of Cardiology.
The new guidelines require groups to:
- Publicly disclose industry support received;
- Decline industry funding for developing medical practice guidelines and require most members to severe financial ties to the industry;
- Disclose leaders' and board members' financial interests in companies; and
- Ban company and product names and logos from products and free giveaways at conferences.
In addition, the code requires medical society leaders and journal editors to forgo consulting deals or financial ties to the industry.
Fourteen of the council's groups already have adopted the code, including the American Society of Clinical Oncology and the College of Physicians, with the rest of the members planning to adopt the guidelines by the end of the year (Marchione, AP/Miami Herald, 4/21).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.