> We sue FDA top brass for defying federal law
>
> We have filed a federal lawsuit against FDA here in Washington, seeking a
court order to force FDA to move forward and asking that mercury fillings be
taken off the market until FDA deigns to act.
>
> The specialized press has begun writing about the case; see, from FDA
Website and FDA Review,
www.toxicteeth.org/Mercury%20Lawsuit%20Likens%20Von%20E%20to%20British%20Queen.pdf -- which highlights our argument that the Commissioner of FDA reigns
over, but does not actually run, his agency.
>
> Here's the background on why we had to sue: Last May, we notified FDA
lawyers that, due to the agency's 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 April. 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 Commissioner's 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 FDA's
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, FDA's 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
doesn't. 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 to us and to the American people -- again. Accordingly, on the
last workday of the calendar year (Fri. Dec. 28, 2007), my co-counsel Bob
Reeves and I, with substantial assistance from lawyer Johann Wehrle, sued.
The 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 children's health,
unborn children's lives, or the environment -- extends deep into the agency.
Accordingly, we sued six individuals at FDA (not just the Commissioner),
going several layers deep into the agency. We are going to stop these
autocratic bureaucrats from hiding behind each other.
>
> Charlie Brown
> 16 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
> [email]charlie@toxicteeth.org;[/email]
www.toxicteeth.org 
