FDA Abandons Pro-Mercury Fillings Policy

 -- Will Propose New Rule

 An intense set of interactions with FDA since the Court of Appeals opinion on April 13 has borne fruit.  On April 19, we advised FDA of liability exposure of key staff, then on May 2 notified FDA lawyers that we had the papers prepared to file another lawsuit unless FDA wanted to meet.  On May 10, top FDA officials met with food and drug law expert Jim Turner and me; we gave FDA a month to change course -- else we would return to court.

Here’s what it means: 

1) The great news:  FDA abandons its policy (expressed in its proposed regulation of 2002) to write into law a sleazy special-interest rule prohibiting warnings, covering up the existence of mercury, and maintaining mercury exposure’s side effect is “allergies.”  After a five-year battle, we broke the A.D.A.’s stranglehold over FDA policy.

(3) The mystery:  With an in-house fight apparently going on between FDA reformers and FDA’s mercury protectors, the result is not predictable.  But at last, top officials are listening to our side -- Professor Boyd Haley, Dr. Rich Fischer, and Dr. Mike Fleming met June 22 with FDA’s Associate Commissioner for Science.  I have written FDA six questions about legally required steps.

We haven’t won – far from it.  But truly, the A.D.A. has lost.  FDA is no longer dancing to its tune.  The issue of mercury toxicity from amalgam will be the subject of a great national debate -- the news the A.D.A. and the pro-mercury dentists have long dreaded. 

Let me not sugar-coat it: a major battle lies ahead as FDA determines its policy, and perhaps at FDA’s typical glacial speed.   We must vigilantly advocate our cause -- inside the agency, before the public, and if necessary back to the courts.  I welcome your views about our next step.  Grassroots activism by consumers, and speaking out by dentists and other health professionals, is more important than ever. 

Charlie Brown

24 June 2007