[Congressional Record (Bound Edition), Volume 147 (2001), Part 9]
[Extensions of Remarks]
[Pages 13255-13256]
[From the U.S. Government Publishing Office, www.gpo.gov]



   AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND 
               RELATED AGENCIES APPROPRIATIONS ACT, 2002

                                 ______
                                 

                               speech of

                        HON. THOMAS G. TANCREDO

                              of colorado

                    in the house of representatives

                        Wednesday, July 11, 2001

       The House in Committee of the Whole House on the State of 
     the Union had under consideration the bill (H.R. 2330) making 
     appropriations for Agriculture, Rural Development, Food and 
     Drug Administration, and Related Agencies programs for the 
     fiscal year ending September 30, 2002, and for other 
     purposes:

  Mr. TANCREDO. Mr. Chairman, I rise in opposition to H.R. 2330, the 
Agriculture Appropriations Act, a bill considered on the floor today 
which makes appropriations for the Department of Agriculture and 
related agencies. But more specifically, I rise in strong opposition to 
the increase provided in the bill for the Food and Drug Administration 
(FDA) and would like to call the House's attention to a problem that 
one of my constituents has been having with the agency and one that I 
believe deserves careful consideration by the oversight committees in 
this chamber.
  Recently, the FDA gave final approval of my constituent's Pre-Market 
Application for both total and partial joint implants after an 
exhaustive and blatantly biased two year review, but not before costing 
his company over $8 million in legal fees, lost wages and profits.
  In April 1999, I received a phone call and letter from TMJ Implants, 
a company located in Golden, Colorado, in my district, which had been 
having problems with the review of its Premarket Approval Application 
of the TMJ Total and Fossa-Eminence Prosthesis. Up until last year, the 
company was the premier market supplier of temporomandibular joint 
prosthesis.
  Over the last two years, I have taken an active interest and an 
active role in monitoring the progress of TMJ Implants' application, 
which was finally approved in February. On numerous occasions, I met 
with Dr. Bob Christensen, President of TMJ Implants, to find out 
information about the approval of the Partial and Total Joint, and 
personally talked to FDA Commissioner Jane Henney and to members of the 
Agency about the status of the company's applications. I was also, and 
continue to be, in contact with the House Commerce Subcommittee on 
Oversight, which has sole jurisdiction over the FDA and issues relating 
to abuse and the internal operations of the agency.
  Specifically, I closely followed this case since my office's first 
contact with Dr. Christensen and TMJ Implants in early May 1999, after 
a meeting of the FDA's Dental Products Panel of the Medical Devices 
Advisory Committee was held to review the company's PMA and recommended 
approval of

[[Page 13256]]

the PMA by a 9-0 vote. From this point onward, the FDA engaged in an 
obvious pattern of delay and deception and even went as far as to 
remove TMJ Implants' Fossa-Eminence Prosthesis from the market, which 
had been available for almost 40 years. This had done nothing more than 
to cause harm to patients and cost the company millions of dollars.
  This was done at the same time that the application for TMJ Concepts, 
a competitor of TMJ Implants, sailed through the process. Several 
allegations have come to light over the last two years detailing the 
fact that several Agency employees have worked under the direction of 
TMJ Concepts' associates.
  The agency went so far as to reconvene a new Medical Devices Advisory 
Committee late last year, with a clear majority of its members lacking 
the required expertise, which denied the company's application.
  It was not until Mr. Bernard Statland, the new Director of the Office 
of Device Evaluation (ODE) was brought in that the logjam was broken 
the PMA was quickly approved.
  As the above demonstrates, several concerns remain about the process 
that has taken place over the last two years. It is no secret that 
everyone involved in this case believes that there have been 
significant questions raised about the process--the sluggish pace of 
the review of the engineering data for both the total and partial joint 
and, more importantly, the constant ``moving of the goal posts'' during 
the review of both PMAs.
  Over the last two years, my office has received numerous letters from 
physicians all across the country--from the Mayo Clinic to the 
University of Maryland--each describing the benefit of the partial 
joint and the fact that the partial and total joint results in 
immediate and dramatic decrease in pain, an increase in range of motion 
and increased function.
  While I am, of course, pleased that the application has been approved 
by the FDA after much delay, the circumstances of the last two years 
calls into question the integrity of the agency and, it is for this 
reason that I bring it to the House's attention.
  Dr. Christensen is a true professional and a pioneer in his field and 
holder of the first patents. His implants are widely accepted as 
effective and safe throughout the dental and surgery community--indeed, 
several of my constituents have literally had their lives changed by 
the procedure. I am convinced that the work of TMJ is and always has 
been based on solid, scientific principles and the removal of the 
implants from the market had been erroneous, contrary to the Agency's 
earlier findings and the statutory standard that should be applied. 
This was devastating to thousands in the general public and devastating 
to the financial status of the company.
  Later this year, the House of Representatives will consider 
legislation reauthorizing the Food and Drug Administration and I would 
like to urge the House Commerce Committee to hold hearings on the TMJ 
Implant case and to conduct a thorough investigation into the FDA's 
review of the Premarket Approval Application of the TMJ Fossa-Eminence 
Prosthesis.
  I would like to take this opportunity to submit into the record two 
articles from FDAWebview which shed light on the TMJ Implant case.

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