[Congressional Record Volume 142, Number 117 (Friday, August 2, 1996)]
[Senate]
[Pages S9560-S9561]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mrs. FEINSTEIN (for herself and Mrs. Boxer):
  S. 2021. A bill to suspend temporarily the duty on certain chemicals 
used in the formulation of an HIV protease inhibitor; to the Committee 
on Finance.


               drug development acceleration legislation

  Mrs. FEINSTEIN. Mr. President, as a nation, 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.
  I rise today to introduce legislation, joined by my colleague Senator 
Boxer, to eliminate the tariff for several chemical compounds. These 
compounds 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. The drugs are designed to block an enzyme, called protease, 
that appears to play a crucial role in the replication of HIV.
  As the Wall Street Journal reported in its coverage of the recently 
concluded 11th International Conference on AIDS in Vancouver, BC, 
researchers have 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/A 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.
  More than 220,700 American men, women and children have 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.
  In my State of California, 1 of every 200 Californians is HIV 
positive, while 1 of every 25 is HIV positive in my home of San 
Francisco.
  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. 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.
  This proposed legislation would 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), from 
August 1 when the drug production increases, until April 1, 1997 when 
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 Federal Government needs to do everything it can to expedite the 
development and distribution of AIDS drugs. Without this legislation to 
remove the tariff, we will be tolerating needless hurdles and delay, 
rather than needed relief.

  The Congressional Budget Office is reviewing the cost of the proposed 
legislation. However, because the WTO negotiations will already provide 
a zero tariff for the chemical compounds on April 1, the legislation 
may have a de minimis impact on tariff revenue. For AIDS patients, 
their families and those at risk, it's a step Congress should take.
  I have also requested various Federal agencies and other 
organizations to review the legislation and ensure that other important 
Federal policies, like narcotics enforcement or maintaining a strong, 
domestic chemical industry, are not undermined. The Drug Enforcement 
Agency and U.S. Customs Service indicate the chemicals present no risk 
for law enforcement or anti-narcotics enforcement priorities. 
Similarly, the U.S. Trade Representative's Industry Sector Advisory 
Committee for chemicals and the International Trade Commission also 
reviewed and approved the administration's efforts to include the 
chemicals in the pharmaceutical appendix negotiations. PhRMA, the 
Pharmaceutical Research and Manufacturers of America, also has reviewed 
the proposal and does not oppose the legislation.
  The administration deserves tremendous credit for extending a zero 
tariff for these chemical components. It is my hope that miscellaneous 
tariff legislation, which is currently pending before the Finance 
Committee, could accommodate this noncontroversial tariff issue, which 
can accelerate the development and production of an AIDS drug, with the 
potential to provide meaningful relief.
  As a matter of public policy, we should do everything we can to 
develop AIDS drugs and treatments. Patients and their families cannot 
wait for the next round of drugs to be approved and added to the zero-
tariff list, scheduled for review in 1999. By importing the chemical 
compounds without a tariff, we can accelerate the drug development 
process.
  I am pleased to introduce this tariff legislation, along with my 
colleague Senator Boxer, and will work with the chairman and ranking 
members of the Finance Committee to pursue the legislation.

[[Page S9561]]

  Mr. President, I ask unanimous consent that the text of the bill be 
printed in the Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                S. 2021

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. TEMPORARY DUTY SUSPENSION.

       (a) In General.--Subchapter II of chapter 99 of the 
     Harmonized Tariff Schedule of the United States is amended by 
     inserting in numerical sequence the following new headings:

``9902.30.6  3-acetoxy-2-                                               
 3.           methylbenzoyl                                             
              chloride (CAS No.                                         
              167678-46-8)                                              
              (provided for in                                          
              subheading                                                
              2918.29.65).........  Free       No change    On or before
                                                             3/30/97    
9902.30.64.  2S, 3R-N-Cbz-3-amino-                                      
              1-chloro-4-                                               
              phenylsulfanyl-butan-                                     
              2-ol (CAS No. 159878-                                     
              02-1) (provided for                                       
              in subheading                                             
              2922.19.60).........  Free       No change    On or before
                                                             3/30/97    
9902.30.65.  N-(1,1-                                                    
              dimethylethyl)deca-                                       
              hydro-2-[2-hydroxy-                                       
              3[(3-hydroxy-2-                                           
              methylbenzoyl)                                            
              amino]-4-                                                 
              (phenylthio)butyl]-3-                                     
              isoquinolinecarboxam                                      
              ide, [3S-                                                 
              [2(2S*,3S*),                                              
              3.a.,4a.b.,8a.b.]]                                        
              (CAS No. 159989-64-                                       
              7) (provided for in                                       
              subheading                                                
              2933.40.60).........  Free       No change    On or before
                                                             3/30/97''. 
                                                                        

       (b) Effective Date.--
       (1) In general.--The amendment made by subsection (a) 
     applies with respect to goods entered, or withdrawn from 
     warehouse for consumption, on or after the date that is 15 
     days after the date of the enactment of this Act.
       (2) Retroactive application.--Notwithstanding section 514 
     of the Tariff Act of 1930 (19 U.S.C. 1514) or any other 
     provision of law, upon proper request filed with the Customs 
     Service, before the 90th day after the date of the enactment 
     of this Act, any entry, or withdrawal from warehouse for 
     consumption, of an article described in heading 9902.30.63, 
     9902.30.64, or 9902.30.65 of the Harmonized Tariff Schedule 
     of the United States (as added by subsection (a)), that was 
     made--
       (A) on or after August 1, 1996, and
       (B) before the date that is 15 days after the date of the 
     enactment of this Act,

     shall be liquidated or reliquidated as though such entry or 
     withdrawal was made on the 15th day after such date of 
     enactment.
                                 ______