FDA Issues Guidance on Waivers, Conflicts of Interest

The Food and Drug Administration has released draft guidance to provide more information on conflicts of interest involving members of its advisory committees and the waivers that allow them to participate in specific meetings.

The guidance aims to bring agency policy in line with standard conflict-of-interest practice in the academic community, where medical journals require disclosures to be specific and thorough, said Jill Hartzler Warner, acting associate commissioner for special medical programs at the FDA.

“When final, the guidance will increase transparency of the waiver process so that the public can understand the nature of the potential conflict,” Ms. Warner said.

The FDA has 49 advisory committees with a total of more than 600 positions that provide advice on specific regulatory decisions, such as drug and device approvals, and general policy matters, such as regulations.

For highly technical subjects, the FDA often must choose from a small pool of potential advisers who frequently have conflicts of interest, she said.

Federal law allows the FDA to grant waivers so experts with conflicts of interest can participate in advisory committee meetings, but the waiver and disclosure process has been controversial. The FDA acknowledged that its decisions could be viewed as tainted if it relies too heavily on experts with conflicts.

When a waiver is granted, federal law requires the FDA to disclose the type, nature, and magnitude of the conflict on its Web site. Ms. Warner said that the law limits the number of waivers to about 13% of all members participating in committee meetings, and in practice the agency grants waivers to fewer than 5%.

Currently, when the FDA decides to grant a waiver, it discloses whether the interest involved is associated with the sponsor, a competitor, or another affected firm. Under the draft guidance, the nature of the waiver granted and name of the companyornvolved would be posted online prior to committee meetings.

As a part of this effort, FDA Commissioner Margaret Hamburg advised senior FDA staff in an April letter to take three steps to minimize conflicts:

▸ Consider the nature of the conflict before granting a waiver. A researcher whose institution receives grants from an affected company but who does not personally participate in the studies has a more tangential relationship to the conflict than does one who conducts studies for the company directly.

▸ Weigh the advisory committee meeting issues. Waivers may be more appropriate for meetings to consider broad policy issues and less appropriate for specific product considerations.

▸ Explain why the individual's participation is needed, and provide information on the search for equally expert advisers without conflicts.

View the draft guidance at www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM209201.pdf

The Food and Drug Administration has released draft guidance to provide more information on conflicts of interest involving members of its advisory committees and the waivers that allow them to participate in specific meetings.

The guidance aims to bring agency policy in line with standard conflict-of-interest practice in the academic community, where medical journals require disclosures to be specific and thorough, said Jill Hartzler Warner, acting associate commissioner for special medical programs at the FDA.

“When final, the guidance will increase transparency of the waiver process so that the public can understand the nature of the potential conflict,” Ms. Warner said.

The FDA has 49 advisory committees with a total of more than 600 positions that provide advice on specific regulatory decisions, such as drug and device approvals, and general policy matters, such as regulations.

For highly technical subjects, the FDA often must choose from a small pool of potential advisers who frequently have conflicts of interest, she said.

Federal law allows the FDA to grant waivers so experts with conflicts of interest can participate in advisory committee meetings, but the waiver and disclosure process has been controversial. The FDA acknowledged that its decisions could be viewed as tainted if it relies too heavily on experts with conflicts.

When a waiver is granted, federal law requires the FDA to disclose the type, nature, and magnitude of the conflict on its Web site. Ms. Warner said that the law limits the number of waivers to about 13% of all members participating in committee meetings, and in practice the agency grants waivers to fewer than 5%.

Currently, when the FDA decides to grant a waiver, it discloses whether the interest involved is associated with the sponsor, a competitor, or another affected firm. Under the draft guidance, the nature of the waiver granted and name of the companyornvolved would be posted online prior to committee meetings.

As a part of this effort, FDA Commissioner Margaret Hamburg advised senior FDA staff in an April letter to take three steps to minimize conflicts:

▸ Consider the nature of the conflict before granting a waiver. A researcher whose institution receives grants from an affected company but who does not personally participate in the studies has a more tangential relationship to the conflict than does one who conducts studies for the company directly.

▸ Weigh the advisory committee meeting issues. Waivers may be more appropriate for meetings to consider broad policy issues and less appropriate for specific product considerations.

▸ Explain why the individual's participation is needed, and provide information on the search for equally expert advisers without conflicts.

View the draft guidance at www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM209201.pdf

The Food and Drug Administration has released draft guidance to provide more information on conflicts of interest involving members of its advisory committees and the waivers that allow them to participate in specific meetings.

The guidance aims to bring agency policy in line with standard conflict-of-interest practice in the academic community, where medical journals require disclosures to be specific and thorough, said Jill Hartzler Warner, acting associate commissioner for special medical programs at the FDA.

“When final, the guidance will increase transparency of the waiver process so that the public can understand the nature of the potential conflict,” Ms. Warner said.

The FDA has 49 advisory committees with a total of more than 600 positions that provide advice on specific regulatory decisions, such as drug and device approvals, and general policy matters, such as regulations.

For highly technical subjects, the FDA often must choose from a small pool of potential advisers who frequently have conflicts of interest, she said.

Federal law allows the FDA to grant waivers so experts with conflicts of interest can participate in advisory committee meetings, but the waiver and disclosure process has been controversial. The FDA acknowledged that its decisions could be viewed as tainted if it relies too heavily on experts with conflicts.

When a waiver is granted, federal law requires the FDA to disclose the type, nature, and magnitude of the conflict on its Web site. Ms. Warner said that the law limits the number of waivers to about 13% of all members participating in committee meetings, and in practice the agency grants waivers to fewer than 5%.

Currently, when the FDA decides to grant a waiver, it discloses whether the interest involved is associated with the sponsor, a competitor, or another affected firm. Under the draft guidance, the nature of the waiver granted and name of the companyornvolved would be posted online prior to committee meetings.

As a part of this effort, FDA Commissioner Margaret Hamburg advised senior FDA staff in an April letter to take three steps to minimize conflicts:

▸ Consider the nature of the conflict before granting a waiver. A researcher whose institution receives grants from an affected company but who does not personally participate in the studies has a more tangential relationship to the conflict than does one who conducts studies for the company directly.

▸ Weigh the advisory committee meeting issues. Waivers may be more appropriate for meetings to consider broad policy issues and less appropriate for specific product considerations.

▸ Explain why the individual's participation is needed, and provide information on the search for equally expert advisers without conflicts.

View the draft guidance at www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM209201.pdf