[Congressional Record Volume 142, Number 138 (Monday, September 30, 1996)]
[Senate]
[Pages S12005-S12006]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




               ACCELERATING THE DEVELOPMENT OF AIDS DRUG

 Mrs. FEINSTEIN. Mr. President, I rise today in appreciation of 
the leadership of Senator Roth, chairman of the Finance Committee, and 
Senator Moynihan, who brought to the Senate and secured passage of 
miscellaneous tariff legislation. The legislation takes a number of 
important steps and deserves our support.
  I am particularly pleased Senator Roth and Senator Moynihan were able 
to incorporate S. 2021, a bill I introduced earlier this year which 
would reduce tariffs for certain chemicals used in a new AIDS drug that 
has shown encouraging test results. Upon approval, the Finance 
Committee bill will take an important step to reduce tariffs for these 
chemicals, which are not available in the United States.
  We must do everything we can to find a cure for HIV/AIDS. However, 
until we have a cure for this urgent health priority, we need to find 
effective treatments and put them in the hands of people with needs. 
This provision will accelerate the manufacturing and final

[[Page S12006]]

testing for a new protease inhibitor and deserves the full support of 
Congress.
  S. 2021, legislation I introduced with my colleague Senator Boxer, 
would eliminate the tariff for several chemical compounds which are 
required for the manufacture of an AIDS drug, nelfinavir mesylate, 
which has produced promising test results.


                          PROTEASE INHIBITORS

  Nelfinavir is one of a new class of AIDS drugs called protease 
inhibitors. These drugs are designed to block an enzyme, called 
protease, that appears to play a crucial role in the replication of 
HIV.
  During the 11th International Conference on AIDS in Vancouver, 
British Columbia, researchers released evidence that protease inhibitor 
drugs, when taken in combination with existing therapies, can reduce 
levels of the AIDS-causing virus in blood to levels so low that the 
virus is undetectable by even the most sensitive tests. AIDS 
researchers at the conference describe this new drug therapy as a major 
and unprecedented step in combating AIDS, one that may represent a 
treatment approach that may delay the onset of AIDS, extend patients' 
lives, and transform AIDS into a long-term, manageable disease.
  Mr. President, HIV/AIDS is a critical public health issue, requiring 
the Nation's full attention. In America today, AIDS is the leading 
cause of death for young Americans between the ages of 25 and 44.
  In my State of California, 1 out of every 200 Californians is HIV 
positive, while one of every 25 is HIV positive in my home of San 
Francisco.
  More than 220,700 American men, women and children died of AIDS by 
the end of 1993. While the number of deaths trails other urgent health 
priorities such as cancer or heart disease, AIDS is nearly equally 
debilitating to the Nation when measured by the years of potential and 
productive life lost due to the disease.

  AIDS is a paramount public health concern and every effort should be 
made to ensure that drugs are made available as swiftly and at as low a 
cost as possible. We simply cannot delay or waste time in providing 
drugs, treatments or materials needed to fight this disease. This 
tariff legislation represents a modest, but important, step.


                    ZERO TARIFF FOR PHARMACEUTICALS

  Under the 1994 GATT agreement, most pharmaceutical products are 
entitled to enter the country without a tariff. However, the zero 
tariff does not apply to many new pharmaceutical products or their 
chemical ingredients. As a result, the chemicals needed to make 
nelfinavir mesylate, an AIDS protease inhibitor currently undergoing 
research testing, but not yet a recognized pharmaceutical product under 
GATT, would be ineligible for the pharmaceutical zero tariff.
  During negotiations with World Trade Organization nations to 
implement the pharmaceutical zero tariff, the administration 
successfully added the chemical compounds needed to manufacture the 
AIDS drug. As a result, the tariff will drop to zero on April 1, 1997.
  Nelfinavir is on the Food and Drug Administration's fast-track 
approval process for AIDS drugs. Commercial production of the drug will 
begin well before April 1, in order that the drug can be immediately 
available to AIDS patients upon FDA approval. Although currently 
imported duty-free for use in clinical research trials, the imported 
chemicals will soon be used for commercial production. During the 
period of commercial production prior to April 1, the chemical 
compounds will face a 12 percent tariff, which will only add to the 
cost and delay the drug's production and distribution to individuals in 
need.
  Fifteen days after enactment, this bill will eliminate the tariff for 
two of the essential and unique chemical inputs, as well as for the 
active ingredient nelfinavir, acid chloride, chloroalcohol and AG 1346, 
until April 1, 1997. On April 1, the tariff drops to zero under the WTO 
pharmaceutical agreement. Without this legislation, the manufacturer 
would face a 12 percent tariff for its chemicals, which are not 
available in the United States, as the drug proceeds into production. 
This tariff reduction will allow for the acceleration of drug 
production, providing more timely relief for the public.
  The Congressional Budget Office reviewed S. 2021, concluding the 
legislation will have only a de minimis impact on tariff revenue. 
However, for AIDS patients, their families and those at risk, the 
impact may be profound. Congress should take this opportunity to reduce 
tariffs for these AIDS chemicals.
  As a matter of public policy, we should do everything we can to 
develop AIDS drugs and treatments. Without this legislation to remove 
the tariff, we will be tolerating needless hurdles and delay, rather 
than expediting needed relief. Patients and their families do not have 
time to wait for the next round of drugs to be approved and added to 
the zero-tariff list, which is scheduled for review in 1999. By 
importing the chemical compounds without a tariff, we can accelerate 
the drug development process.
  Ambassador Barshefsky and others in the Administration deserve 
tremendous credit for extending a zero tariff for these chemical 
components through international negotiations. I am pleased to support 
Chairman Roth and Senator Moynihan, the Finance Committee bill. I also 
wish to thank California Representatives Bill Thomas, Robert Matsui and 
Brian Bilbray for their bipartisan efforts to build support on the 
House. The legislation represents an encouraging step forward.

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