FDA Webview, 01/04/2012
Despite publicly asserting several times that he hoped to take action on petitions to reconsider the safety of dental amalgam by the end of 2011 after the World Health Organization called for a phase-down, CDRH director Jeffrey Shuren has let that informal deadline pass unmet. When asked what the new timeline goal is, FDA spokesperson Morgan Liscinski responded that there isn’t one.
FDA’s history of regulating dental amalgam is tortuous. For 32 years it refused to publicly warn about its neurotoxic risks until compelled in 2009 by federal court action to classify it. Even then, the agency’s action – declaring it as safe under Class 2 for everyone over age 6 who is not allergic to mercury – was immediately faulted by dental activists as weak and based on selective reading of the scientific literature on the topic.
Dr Markus has now addressed the FDA on three separate occasions, and they promise to move forward, but there must be more sinister forces underlying this issue, because they refuse to act. Here is a link to Dr. Markus’ and others speeches before the FDA Panel at the end of 2010.
Within two months of the rule’s publication in the Federal Register, two citizen petitions asked the agency to reconsider it, and a month later a World Health Organization expert group agreed in concept for a worldwide phasing down of dental amalgam. Goaded by such pressures, FDA eventually agreed to ask an advisory panel in December 2010 to examine the latest science; it voted to recommend a ban on amalgam’s use in children.
Still the agency hesitated, sending Shuren to a series of town hall meetings around the country at which he heard so much criticism of the agency’s amalgam policy that he began saying he hoped for agency action on it by the end of 2011.
Liscinsky’s comment suggests that after waiting 35 years on the amalgam safety issue, not to mention its similar delay on deciding not to move against food animal use of tetracycline and penicillin, FDA sees no need to hurry now.
National counsel for Consumers for Dental Choice Charlie Brown commented:
“At Jeff Shuren’s Center for Devices, politics wins. Science loses. Thirteen months ago, FDA’s own advisory panel of handpicked scientists told FDA to stop amalgam use for children and pregnant women.
“But Shuren fails to heed the scientists – even though, since September, he repeatedly announced that he intended to act on amalgam in 2011. Every day that Shuren fails to act, more children are subjected to this mercury product, which – FDA’s own rule concedes – can have ‘neurotoxic effects’ on the ‘developing neurological systems’ of children and unborn babies.”