[Congressional Record Volume 142, Number 10 (Thursday, January 25, 1996)]
[Extensions of Remarks]
[Page E102]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                       STATE OF THE UNION MESSAGE

                                 ______


                            HON. BOB CLEMENT

                              of tennessee

                    in the house of representatives

                       Thursday, January 25, 1996

  Mr. CLEMENT. Mr. Speaker, last Tuesday evening we heard the President 
of the United States eloquently proclaim to the American people that 
the ``era of big government is over,'' that ``big government does not 
have all the answers,'' that ``there is not a program for every 
problem,'' and how ``we need a smaller, less bureaucratic government in 
Washington.''
  Mr. Speaker, I could not agree with the President more, and I venture 
the vast majority of working men and women in my district agree with 
him as well. But at the same time the President is preaching small 
Government, the Food and Drug Administration is proceeding in the 
opposite direction.
  There are probably few Federal agencies which personify better than 
the FDA the inherent dangers of the kind of large, unwieldy, arrogant, 
and power-hungry bureaucracies which characterize the big Government 
condemned last night by the President.
  By its estimates, the Food and Drug Administration regulates 
approximately 25 cents out of every dollar spent by Americans on 
products. Food and Drug Administration rules currently occupy 
approximately 4,270 pages of the Code of Federal Regulations.
  But despite, or maybe as a result of, this wide reach, the agency had 
failed miserably in carrying out its core mission of approving promptly 
and efficiently new medical technologies, devices and pharmaceuticals. 
As a result, costs of these products have propelled skyward; the 
research and manufacture of these products has been chased overseas, 
and absurd scarcities have been created whereby literally hundreds of 
potentially life-saving technologies and medicines are widely available 
abroad, but not here in America.
  For example, during the last fiscal year, it took an average of 7 
months for the FDA to review so-called 510K applications for low-risk 
medical devices--those which may duplicate devices already in the 
market. This is almost three times longer than it took in 1989 and well 
beyond the agency's statutory requirement of 90 days. The FDA's review 
of more complicated products, such as implants and those which may pose 
serious risks in the event of failure (so-called Class III devices) now 
takes an average of three years, despite the fact that the law requires 
this review process to be completed within 180 days.
  In addition, the amount of time it takes to move a drug from 
laboratory to market has doubled since 1962 (from an average of 6 years 
then, to 12 years now). As approval time for drugs has lengthened, the 
costs pharmaceutical firms incur bringing a drug to market have 
similarly increased. In the 1970's, it cost approximately $50 million 
and took 5 to 7 years to develop a new drug. By the 1980's, the cost 
had increased to an average of $231 million. By the early 1990's, the 
cost had increased to about $369 million. Is it any wonder, then, that 
the cost to American consumers of prescription drugs has increased by 
137 percent?
  But, instead of seeking ways to do a better job at the tasks to which 
it is already assigned, the FDA now proposes, in 140 pages of the 
Federal Register, to expand its jurisdiction to include control over 
tobacco, its sales, its distribution, its advertising and promotion.
  This past Friday, the Department of Health and Human Services 
published its final rule for implementation of provisions of the 
Alcohol, Drug, and Mental Health Administration Reorganization Act of 
1992 restricting Federal assistance to States which fail to enact and 
enforce statutes prohibiting tobacco sales to minors, conduct random 
inspections, and meet certain reporting obligations.
  Although almost 2 years and 5 months have passed since the agency 
published its preliminary regulations, last week's action comes at an 
opportune time; specifically in the middle of a debate as to what role, 
if any, the FDA should have in regulating tobacco. If it seems somewhat 
inconsistent for HHS to be issuing regulations imposing on the States 
the responsibility for dealing with underage tobacco use at the same 
time the FDA is attempting to grab authority to manage this issue from 
the Federal level, that is because it is inconsistent.
  Beyond this inconsistency, as a matter of practicality and 
efficiency, it makes little sense for the FDA to spend its time 
attempting to assume the very expensive, far-reaching, and time 
consuming responsibilities entailed in managing underage tobacco use at 
a time when the agency has proven itself incapable of performing 
adequately its core mission of approving medical devices and drugs.
  I agree with the goal of preventing underage tobacco use. But if the 
FDA cannot currently perform its core missions, what reason is there to 
believe it can effectively prevent underage tobacco use? Further 
diluting FDA's energies to take on a task which is outside its 
statutory jurisdiction will not prevent teenagers from smoking. But it 
will serve to further detract the agency from its primary mission of 
approving promptly safe new medicines and medical devices.
  That is why the public interest will best be served by the FDA 
dropping its unauthorized campaign against tobacco and refocusing its 
efforts to fulfill its core mission while the States and the Federal 
Government work together to assure efficient and effective 
implementation of the ADAMHA Reorganization Act of 1992.

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