[Congressional Record Volume 142, Number 137 (Saturday, September 28, 1996)]
[Extensions of Remarks]
[Pages E1788-E1789]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




  THE HEALTH CARE RESEARCH AND DEVELOPMENT AND CONSUMER PROTECTION ACT

                                 ______
                                 

                          HON. BERNARD SANDERS

                               of vermont

                    in the house of representatives

                       Friday, September 27, 1996

  Mr. SANDERS. Mr. Speaker, the U.S. taxpayer is the single largest 
supporter of biomedical research in the world, spending $33 billion--in 
1994 alone--for biomedical and related health research. Yet the 
taxpayer is not getting a fair return on their investment--paying twice 
for health care inventions, first as taxpayers and second as consumers.

[[Page E1789]]

  It is incumbent upon the Secretary of Health and Human Services to 
require a reasonable relationship between the pricing of drugs, the 
public investment in those drugs, and the health and safety needs of 
the public. Unfortunately, taxpayer accountability was tossed aside 
when the Nation's reasonable pricing policy on drugs--which was put in 
place by the bush administration--was dropped in April 1995.
  The reasonable pricing clause was dropped after extensive review of 
the policy, even though the review resulted in no certain 
recommendations. The rationale for this decision was that ``the pricing 
clause had driven industry away from potentially beneficial scientific 
collaborations with the Public Health Service.'' Yet, there was no hard 
evidence given during the review to show that this was the case--only 
anecdotal stories by the drug industry.
  When 42 percent of all U.S. health care research and development 
expenditures is paid for by the taxpayer, and 92 percent of the cancer 
drugs developed since 1955 were developed with Federal funding, we owe 
it to the taxpayer to give them a fair return on their investment with 
a reasonable price on the drugs they paid to develop. The Health Care 
Research and Development and Consumer Protection Act reinstates the 
reasonable pricing clause and gives the Secretary of HHS the authority 
to waive the clause when it is determined to be in the public interest 
to do so.
  In determining a reasonable price for a drug, the Secretary shall 
consider--
  The public interest in continued health care research and 
development;
  The contribution of the person marketing such drug to the drug 
research and development expenses, including the amount, timing, and 
risk of investment in such research development;
  The contribution of the Federal Government to the research and 
development of such drug, including the amount, timing, and risk of 
investment in such research and development;
  The therapeutic value of such drugs;
  The number patients who are expected to purchase drug;
  The cost of producing and marketing of such drug;
  The cost of therapies which are similar to the therapy using such 
drug; and
  Other relevant factors.
  In addition to restoring the reasonable pricing clause, this 
legislation will promote the research and development of new drugs by 
requiring the Secretary of Health and Human Services to adopt rules 
which set out minimum levels of reinvestment in research and 
development for persons engaged in the manufacture of drugs sold in the 
United States.
  I urge my colleagues to restore accountability to the U.S. taxpayer 
and support The Health Care Research and Development and Consumer 
Protection Act.

                          ____________________