Last May, we notified FDA lawyers that, due to the agencys decades of
(illegal) intransigence in classifying mercury amalgam, we were preparing a
complaint in the US District Court, pursuant to the guideposts from the US Court
of Appeals ruling in
Moms Against Mercury v. FDA. FDA asked us for a
meeting instead. At that meeting with top FDA officials, Dr. Mike Fleming,
lawyer Jim Turner, and I were told that FDA realized it needed to move forward;
we said we would wait 30 days.
At the end of that 30 days (in June 2007), the FDA Commissioners office
phoned and said with enthusiasm, You will like our plan, promising details the
next day. The next day, FDA counsel phoned me and said FDA intended to begin
the classifying process, by issuing an Advanced Notice of Proposed Rulemaking
(ANPR). I asked the lawyer to put that promise in writing, which she did. I
then immediately contacted two reporters (from
FDA Week and the
Bureau of Nat. Affairs Medical Devices Reporter), both of whom called
FDAs press office, which confirmed the agency would issue such an Advanced
Notice of Proposed Rulemaking, by the end of the calendar year at the latest.
Month after month, we waited. No ANPR issued. In November, FDA witness
Norris Alderson, FDAs lead scientist (his degree is in veterinary medicine),
appeared before Congress and stonewalled, repeatedly misleading Congress and
refusing even to commit to doing an Environmental Assessment (legally
required). Over the past 15 years, FDA repeatedly promises (to courts, to
Congress, to petitioners) to classify mercury fillings -- then doesnt. Fool me
once, shame on you; fool me repeatedly, shame on me. So I guess the shame is on
me for, in my naiveté, actually believing FDA when the agency lawyers make a
written promise.
FDA lied. Accordingly, on the last workday of the
calendar year (Fri. Dec. 28, 2007), my co-counsel Bob Reeves and I sued. The
detailed lawsuit is at www.toxicteeth.org/Complaint_Dec282007.pdf
The malfeasance at FDA -- this sequence of illegal actions to shield
dentists pocketbooks instead of showing any concern with childrens health,
unborn childrens lives, or the environment -- extends deep into the agency.
Accordingly, we sued six individuals at FDA (not just the Commissioner), going
five layers deep into the agency. We are going to stop these autocratic
bureaucrats from hiding behind each other.
Charlie Brown
9 January 2008
Charles G. Brown,
National Counsel
Consumers for Dental Choice
316 F St., N.E., Suite 210 ,
Washington, DC 20002
Ph. 202.544-6333; fax 544-6331
charlie@toxicteeth.org; www.toxicteeth.org
