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FDA improves advisory committee process

Device Regulation Alert: Safety, Compliance and Reimbursement News, November 26, 2007

The FDA announced various efforts to improve the FDA Advisory Committee in a November 15, 2007 release. The FDA uses the advisory committee process to gain input from independent experts about issues concerning medical devices and other FDA regulated products.

Committees may include healthcare professionals and consumer, industry, and even patient representatives. The FDA makes the final decisions with regard to FDA regulated products after receiving advice from these committees.

To improve the advisory committee process, the FDA:

• Formalized operating procedures concerning security and public conduct during meetings
• Improved access on the FDA's advisory committee Web page to information about waivers granted for conflicts of interest and updated information about the advisory committee process.
• Created an advisory committee that will recommend ways to communicate risks and benefits of FDA regulated products and announced the members in a November 5, 2007 press release.
• Released an October 26, 2007 study report concerning conflicts of interests among advisory committee members. The study considered whether it is appropriate to grant waivers to committee members who may have a financial conflict of interest and noted the need to retain members with the appropriate level of expertise. The report found it may be difficult to create an advisory committee whose members are completely free of any conflicts.

In addition, the FDA released new draft guidance in November 2007 on voting procedures for advisory committee meetings. The guidance recommends simultaneous voting. Click here to read the guidance.

The FDA also issued draft guidance in October 2007 regarding public disclosure of committee members' financial interests that create conflicts of interest. Click here to read the guidance.

Click here to read the FDA's November 15 press release announcing and summarizing all these initiatives.

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