DSB Members Will Be Held to Strict Conflict-of-Interest Rules, FDA Says
The FDA's new Drug Safety Oversight Board (DSB) will enforce strict conflict-of-interest rules to ensure its members make independent decisions, according to top agency officials who acknowledged that the duties of the board are still a work in progress.
Board members directly involved in making a regulatory decision about a product that comes before the panel will be recused from voting on that particular drug, said Steven Galson, acting director of the Center for Drug Evaluation and Research (CDER). There will be no exceptions to that rule, Galson said during a webcast sponsored by the Drug Information Association and CDER.
"It has been very controversial that many times we waive these conflict-of-interest [rules] for our advisory committees," Galson said. "We won't be doing that for the [oversight] board. There will be no waivers."
The DSB membership was announced May 18. CDER officials will hold 14 of the 18 seats on the board, a majority voting block that some critics contend will prevent the panel from making impartial decisions.
Galson addressed a related criticism that the board will not be truly independent because it is comprised mainly of FDA employees: The people who participate in policy discussions won't be the same people who are directly involved in approving the drug, he said. "So it really is independent, and it is a different viewpoint and perspective."