[Congressional Record Volume 143, Number 160 (Thursday, November 13, 1997)]
[Extensions of Remarks]
[Pages E2388-E2389]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




CONFERENCE REPORT ON S. 830, FOOD AND DRUG ADMINISTRATION MODERNIZATION 
                              ACT OF 1997

                                 ______
                                 

                               speech of

                            HON. RICK LAZIO

                              of new york

                    in the house of representatives

                        Sunday, November 9, 1997

  Mr. LAZIO of New York. Mr. Speaker, I am proud to be part of this 
effort to reform the Food and Drug Administration and to reauthorize 
the Prescription Drug User Fee Act [PDUFA]. The legislation we consider 
today is good for seniors, good for children, good for the critically 
ill, and good for America. This bill will save American lives. I would 
like to highlight one of the many examples of the need for reform, as 
well as one particular section of this legislation.
  In the beginning of the year the FDA claimed that it was approving 
drugs faster than ever. The FDA's claims, however, are contradicted by 
the harsh reality that many drugs not available to Americans today have 
been available in Europe and abroad for years.
  For example, the drug Ancrod prevents and treats blood clots and is 
used to treat strokes. Ancrod has been the subject of extensive testing 
in the United States since the late 1980's, even though it has been 
broadly available to the public in the United Kingdom for the last 23 
years.
  The General Accounting Office testified in 1979 that Ancrod should be 
made available to the public as soon as possible. Eighteen years later, 
Ancrod is still not available to the American public. Nearly 500,000 
Americans suffer strokes each year, but are denied the benefits of 
Ancrod by the FDA. I know first hand of the devastation that strokes 
can cause. My father had two strokes, one in 1978 and another in 1985.
  Separately, this legislation includes a provision which will make 
important health information widely available to the American public.
  This provision, based on a bill I introduced, will provide a one-stop 
information service for individuals with serious or life-threatening 
diseases. The program will create one data bank of research information 
by integrating and coordinating existing data banks across America.
  The data bank will include a registry of clinical trials, both 
federally and privately funded, of experimental treatments for serious 
or life-threatening diseases and conditions. The registry will contain 
a description of the purpose of each experimental drug protocol. All 
this information will be available by calling a 1-800 number, and 
through other means such as the Internet.
  This bill is an important piece of legislation for the American 
people. I urge my colleagues to support its passage.

[[Page E2389]]



                          ____________________