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FDA posts documents for Dec. 14-15 amalgam review

Washington—The U.S. Food and Drug Administration will convene a dental advisory panel Dec. 14-15 to discuss “whether FDA appropriately represented the strengths and weaknesses of the available clinical data” in issuing 2009 dental amalgam regulations.

The Association supports the 2009 regulations and “strongly urges” the advisory panel to do likewise and assure the FDA that it made the right decision then and should stick to its regulatory course in light of the scientific evidence.

The FDA will ask the dental products panel to discuss three sets of scientific questions but will not ask the panel to vote on anything. “There will be no votes taken,” Nancy Stade, deputy director for policy of FDA’s Center for Devices and Radiological Health, told national media representatives in a telephone briefing Dec. 9.

“These discussions are incredibly important to the FDA,” she said. “We are seeking input on scientific questions and that analysis will inform our regulatory approach.”

  • The first set of questions concerns the level of exposure to mercury that amalgam bearers receive from their dental amalgams, the FDA said.
  • The second set of questions concerns how the Reference Exposure Level (REL) for elemental mercury—or the level considered protective assuming chronic exposure of the general population and vulnerable subpopulations—should be determined.
  • The third set of questions concerns clinical studies of exposure to dental amalgam.

“Your answers to these questions will assist the FDA in evaluating its current regulatory approach and whether changes to that approach are warranted,” the agency said in a document released Dec. 10.

The FDA will ask the advisory panel to “discuss whether FDA appropriately represented the strengths and weaknesses of the available clinical data” in its 2009 regulation of dental amalgam. “Based on your answers to these three sets of questions, discuss how FDA should weigh the risk assessment and the clinical studies in considering its regulatory approach to dental amalgam,” the document concludes.

The FDA posted additional hearing documents here.