FDA Issues Draft Guidance on Committee Waivers, Disclosures

The Food and Drug Administration released draft guidance yesterday designed to provide more information on conflicts of interest involving members of its advisory committees and the waivers that allow them to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The draft guidance is designed to bring agency policy in line with standard conflict of interest practice in the academic community, where medical journals require disclosures to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, Jill Hartzler Warner, acting associate commissioner for special medical programs at the FDA, said in a press briefing.

"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 advisors, and these people frequently have conflicts of interest, she said.

Federal law allows the FDA to grant waivers so that experts who have conflicts of interest can participate in advisory committee meetings; however, the waiver and disclosure process has been controversial, and 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, the agency discloses whether the interest involved is associated with the sponsor, a competitor, or another affected firm. For example, the FDA might report the conflict as "holds $0-$5,000 of stock in a competitor company."

Under the draft guidance, the agency would expand the information disclosed about waivers so that the nature of the waiver granted and name of the company or institution involved also would be posted online prior to committee meetings.

"It's clearly better for the agency when advisory committee members have no conflict of interest, but many of the top authorities may have conflicts of interest," Ms. Warner said.

As a part of this effort, FDA Commissioner Dr. Margaret Hamburg told senior FDA staff in a letter yesterday that they should take three steps to minimize conflicts of interest among advisory committee members:

- Consider the nature of the conflict before granting a waiver. "An academic 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 the researcher who conducts studies for the company directly," Dr. Hamburg wrote.

- Look at what will be considered at the advisory committee meeting. Waivers may be more appropriate for meetings to consider broad policy issues and less appropriate for specific product considerations, according to the letter.

- Provide an explanation of why the individual's participation is needed despite the conflict of interest, as well as information on the search for equally expert advisors without conflicts.

The Food and Drug Administration released draft guidance yesterday designed 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 draft guidance is designed 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, Jill Hartzler Warner, acting associate commissioner for special medical programs at the FDA, said in a press briefing.

"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 advisors, and these people frequently have conflicts of interest, she said.

Federal law allows the FDA to grant waivers so that experts who have conflicts of interest can participate in advisory committee meetings; however, the waiver and disclosure process has been controversial, and 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, the agency discloses whether the interest involved is associated with the sponsor, a competitor, or another affected firm. For example, the FDA might report the conflict as "holds $0-$5,000 of stock in a competitor company."

Under the draft guidance, the agency would expand the information disclosed about waivers so that the nature of the waiver granted and name of the company or institution involved also would be posted online prior to committee meetings.

"It's clearly better for the agency when advisory committee members have no conflict of interest, but many of the top authorities may have conflicts of interest," Ms. Warner said.

As a part of this effort, FDA Commissioner Dr. Margaret Hamburg told senior FDA staff in a letter yesterday that they should take three steps to minimize conflicts of interest among advisory committee members:

- Consider the nature of the conflict before granting a waiver. "An academic 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 the researcher who conducts studies for the company directly," Dr. Hamburg wrote.

- Look at what will be considered at the advisory committee meeting. Waivers may be more appropriate for meetings to consider broad policy issues and less appropriate for specific product considerations, according to the letter.

- Provide an explanation of why the individual's participation is needed despite the conflict of interest, as well as information on the search for equally expert advisors without conflicts.

The Food and Drug Administration released draft guidance yesterday designed 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 draft guidance is designed 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, Jill Hartzler Warner, acting associate commissioner for special medical programs at the FDA, said in a press briefing.

"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 advisors, and these people frequently have conflicts of interest, she said.

Federal law allows the FDA to grant waivers so that experts who have conflicts of interest can participate in advisory committee meetings; however, the waiver and disclosure process has been controversial, and 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, the agency discloses whether the interest involved is associated with the sponsor, a competitor, or another affected firm. For example, the FDA might report the conflict as "holds $0-$5,000 of stock in a competitor company."

Under the draft guidance, the agency would expand the information disclosed about waivers so that the nature of the waiver granted and name of the company or institution involved also would be posted online prior to committee meetings.

"It's clearly better for the agency when advisory committee members have no conflict of interest, but many of the top authorities may have conflicts of interest," Ms. Warner said.

As a part of this effort, FDA Commissioner Dr. Margaret Hamburg told senior FDA staff in a letter yesterday that they should take three steps to minimize conflicts of interest among advisory committee members:

- Consider the nature of the conflict before granting a waiver. "An academic 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 the researcher who conducts studies for the company directly," Dr. Hamburg wrote.

- Look at what will be considered at the advisory committee meeting. Waivers may be more appropriate for meetings to consider broad policy issues and less appropriate for specific product considerations, according to the letter.

- Provide an explanation of why the individual's participation is needed despite the conflict of interest, as well as information on the search for equally expert advisors without conflicts.