FDA proposes rules for conflict of interest disclosure for committee members

WASHINGTON The Food and Drug Administration has announced proposed rules that will reduce the potential conflicts of interest among outside experts who advise the government on the approval of drugs and other regulated products, according to washingtonpost.com.

Experts on the advisory committees would have to fill out a form disclosing the potential conflicts and explaining why they should still be able to advise the agency. If the FDA agrees to a waiver, the disclosure form would be posted on the FDA’s website for at least 15 days before the committee meets.

The goal now is to have that process “conducted in an open, transparent way so people will have confidence and the appropriate trust,” the FDA’s commissioner, Dr. Andrew von Eschenbach, told reporters.

Under the current system, outside advisers inform the FDA of potential conflicts. The agency may grant a waiver if it is deemed in the best interest of the advisory process to have the expert’s input. The FDA then announces when waivers are granted but does not routinely release the disclosure documents.

The proposed rules will be open for public comment for 60 days before the FDA makes a decision whether to revise or adopt them.

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