[Congressional Record (Bound Edition), Volume 147 (2001), Part 16]
[House]
[Page 23279]
[From the U.S. Government Publishing Office, www.gpo.gov]



                             SPECIAL ORDERS

  The SPEAKER pro tempore (Mr. Simpson). Under the Speaker's announced 
policy of January 3, 2001, and under a previous order of the House, the 
following Members will be recognized for 5 minutes each.

                              {time}  2200
                               GLUCOPHAGE

  The SPEAKER pro tempore (Mr. Simpson). Under a previous order of the 
House, the gentleman from New Jersey (Mr. Pallone) is recognized for 5 
minutes.
  Mr. PALLONE. Mr. Speaker, I rise on the House floor to express my 
deep concerns regarding the lobbying efforts of Bristol-Myers-Squibb to 
block access to affordable generic alternatives to their blockbuster 
diabetes drug Glucophage.
  The FDA's Office of Generic Drugs has numerous generic versions of 
this diabetes drug awaiting approval. However, the office is unable to 
allow these generics onto the market due to Bristol's monopoly. There 
are no patents blocking the approval of generics in this case. The only 
obstacle is a result in the loophole in the Waxman-Hatch exclusivity. 
It allows Bristol to obtain 3 years of Waxman-Hatch exclusivity in 
addition to 6 months of pediatric exclusivity for a new indication, the 
use of this drug for treatment of Type 2 diabetes in pediatric patients 
ages 10 to 16 years.
  Mr. Speaker, the pediatric research conducted on this drug has 
yielded useful results for pediatric use. However, Bristol should not 
be allowed a total of 3 years plus 6 months of exclusivity for changing 
its label to indicate pediatric use. This only leads to 3 years and 6 
months more of keeping valuable generics off the market.
  The FDA regulations authorize a generic manufacturer to carve out of 
its labeling indications that are protected by patents or exclusivity. 
Therefore, there does not seem to be any reason why the generic forms 
of this diabetes drug cannot be approved now without the pediatric 
indication.
  This specific drug is effective for millions of Americans with Type 2 
diabetes. Type 2 diabetes affects the minority population 
disproportionately, many of whom cannot afford to pay the higher 
monopoly prices for this life-saving drug. Access to more affordable 
generic versions of this drug will undoubtedly serve as a life-saving 
option.
  Mr. Speaker, there is currently a legislative fix in place in the 
House and Senate version of the pediatric exclusivity bill that would 
close this loophole and allow generic versions of this diabetes drug to 
compete with Bristol's Glucophage. As Members commence conferencing on 
this bill, it is crucial that this language remain intact.
  Bristol-Meyers-Squibb is sweeping through key offices on Capitol Hill 
in an effort to retain its exclusive marketing monopoly on its near 80-
year-old profitable drug, Glucophage, which reaps about $1.8 billion in 
annual sales.
  Mr. Speaker, I encourage my colleagues working on the pediatric 
exclusivity bill to keep the current language regarding this important 
issue in place and not to lose this battle with the drug industry. We 
have lost it too many times, and given the current circumstances, let 
us do something for once that will help the consumers of America, who 
not only have to deal with the weak economy, but also a life-
threatening illness such as diabetes.
  Let us fight against Bristol-Myers-Squibb and close the Waxman-Hatch 
loophole.

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