To change FDA policy, we tried petitions, Congressional hearings, state fact sheet laws, Scientific Advisory Committee hearings, and letters galore — to no avail. So in the great American tradition, we sued. The case came to a head this spring. On April 22, working with Johann Wehrle and Gwen Smith, I filed a motion for an injunction before Judge Ellen Huvelle. Three sets of briefs later, the government and I presented our oral arguments on May 16. In a crucial ruling, Judge Huvelle ruled that our 11 plaintiffs — the diverse group
listed below — have standing. She said FDA should classify, and invited the two sides to mediate. On May 30, before Magistrate Judge John Facciola, Bob Reeves (who flew in from Lexington KY) and I hammered out an agreement with FDA officials and lawyers.
The impact of the re-writing of its position on amalgam can hardly be understated. [A curious mistake: the writer means overstated.] FDAs website will no longer be cited by the American Dental Association in public hearings. FDA shows awareness of the key issues involved. As it prepares to classify amalgam, FDA has moved to a position of neutrality. Indeed, having repeatedly raised the question of amalgams risk to
children, young women, and the immuno-sensitive persons in its website, I find it inconceivable that FDA will not in some way protect them in its upcoming rule.
Mercury fillings were once very common and are still common. Unfortunate that it took a lawsuit to get the FDA to change. Judges have little or no relevant experience understanding scientific papers. Scientific advisory panels have much more relevant experience. However, they suffer from a “purity” bias – they are evidence snobs.