[Congressional Record Volume 141, Number 130 (Saturday, August 5, 1995)]
[Extensions of Remarks]
[Page E1656]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]


       FDA IS CRITICAL TO THE HEALTH AND PROSPERITY OF OUR NATION

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                            HON. BOB CLEMENT

                              of tennessee

                    in the house of representatives

                         Friday, August 4, 1995
  Mr. CLEMENT. Mr. Speaker, regardless of one's view of tobacco, it is 
clear that an efficient and effective FDA is critical to the health and 
prosperity of our Nation. Roughly 25 percent of every American consumer 
dollar spent is spent on products FDA is responsible for overseeing. 
Tobacco is not one of those products. FDA clearly lacks any semblance 
of statutory authority to regulate tobacco products as drugs, yet Dr. 
David Kessler seems intent on pursuing this politically correct agenda 
at the expense of the agency's core mission.
  FDA's product approval process demands the Commissioner's attention. 
The backlog of pending medical device applications exceed 1,100. Drug 
approval times averaged 29 months in 1991, despite a statute mandated 
time limit of 180 days. Approximately 80 percent of the drugs approved 
by the FDA between 1987 and 1989 were available in other countries an 
average of 6 years earlier.
  While FDA has been investigating and inspecting tobacco company 
manufacturing processes, inspections of domestic products and 
manufacturing plants are unacceptably low. Recent rates indicate that 
FDA will visit each of the 90,000 establishments subject to inspection 
every 6 years instead of the two required by statute.
  Dr. Kessler may say the agency is improving, but the fact remains 
under his leadership the agency continues to fail to meet its statutory 
obligations. In April 1995, Dr. Charles Edwards--FDA Commissioner from 
1969 to 1973--criticized the FDA for spending valuable resources 
investigating tobacco while it is unable to perform important functions 
within its authority. Dr. Edwards said:

       FDA's paternalistic tendency in recent years is, in my 
     opinion, more than bad policy. It is bad management. It 
     diverts limited resources from key tasks and drug and medical 
     device approvals.

  And in response to a question, Dr. Edwards directly criticized Dr. 
Kessler's private crusade against tobacco products. ``I feel very 
strongly about this, that you cannot regulate human behavior. This is 
really an issue for the Surgeon General.'' He added, ``I think issues 
like this divert the resources of the Agency--enormous resources of the 
Agency.''
  Mr. Speaker, it is time for the President to end Dr. Kessler's ill-
conceived crusade against tobacco. Clearly, the Agency does not have 
the resources to justify it. Further, it lacks the legal authority to 
regulate tobacco products. It is high time the President directed Dr. 
Kessler to run the FDA in a manner the American people deserve and that 
he abandon his thinly veiled crusade to begin our inexorable march 
towards America's next experiment with prohibition.


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