[Congressional Record Volume 155, Number 136 (Thursday, September 24, 2009)]
[Senate]
[Pages S9853-S9854]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




 SENATE RESOLUTION 287--HONORING THE 25TH ANNIVERSARY OF THE ENACTMENT 
 OF THE DRUG PRICE COMPETITION AND PATENT TERM RESTORATION ACT OF 1984 
                         (THE HATCH-WAXMAN ACT)

  Mr. BROWN submitted the following resolution; which was referred to 
the Committee on the Judiciary:

                              S. Res. 287

       Whereas on September 24, 1984, the Drug Price Competition 
     and Patent Term Restoration Act of 1984 (Public Law 98-417; 
     98 Stat. 1585), commonly known as the Hatch-Waxman Act, was 
     signed into law by President Ronald Reagan, at which time 
     President Reagan indicated that generic drugs might save 
     American consumers $1,000,000,000 over the next 10 years;
       Whereas this landmark law created the regulatory mechanism 
     under which the Food and Drug Administration approves safe 
     and affordable generic drugs;
       Whereas each year for the past quarter century, the generic 
     pharmaceutical industry has delivered billions of dollars in 
     savings on the purchase of prescription drugs, far exceeding 
     the original estimate;
       Whereas a May 2009 report showed that during the preceding 
     10-year period, the use of generic drugs has saved the 
     American health care system more than $734,000,000,000, with 
     the most-recent annual average exceeding $121,000,000,000;
       Whereas generic drugs accounted for more than 72 percent of 
     all prescription drugs dispensed, yet accounted for only 17 
     percent of the spending on all prescription drugs, a 
     differential that reflects the dramatically lower prices paid 
     for generic drugs, which not only reduces consumer and 
     taxpayer spending but also increases patient access to needed 
     medicines; and
       Whereas while the Hatch-Waxman Act does not have an 
     explicit pathway for approval by the Food and Drug 
     Administration of lower-priced versions of cutting-edge 
     biologic medicines, which account for a rapidly growing 
     portion of prescription medicine spending, the Act does 
     provide a solid framework for such a pathway: Now, therefore, 
     be it
       Resolved, That it is the sense of Senate that--
       (1) enactment of the Hatch-Waxman Act (Public Law 98-417; 
     98 Stat. 1585) in 1984 served to create the modern generic 
     pharmaceutical industry, which has provided consumers with 
     access to affordable drugs, yielding significant health and 
     economic benefits for the Nation's health care system;
       (2) Senator Orrin Hatch and Representative Henry Waxman 
     deserve the Nation's gratitude for authoring and championing 
     this landmark bipartisan legislation; and
       (3) Congress should build on the work of these dedicated 
     policymakers and enact legislation to create a pathway for 
     approval by the Food and Drug Administration of safe and 
     affordable generic versions of biologic medicines.

  Mr. BROWN. Mr. President, I rise today to submit a resolution 
commemorating the 25th Anniversary of the Drug Price Competition and 
Patent Term Restoration Act, more commonly known as the Hatch-Waxman 
Act.
  This historic legislation--which was signed into law exactly 25 years 
ago today, on September 24, 1984--marked the culmination of months of 
lengthy and often contentious debate over how to foster pharmaceutical 
innovation while at the same time encouraging competition from 
affordable generic prescription drugs.
  Guided by my good friends and colleagues Representative Henry Waxman 
of California and Senator Orrin Hatch of Utah, Congress delivered a 
bill that struck the right balance between innovation and access, and 
put in place a new regulatory pathway to bring safe and effective 
generic medicines to market.
  I doubt that anyone involved in the passage of Hatch-Waxman could 
have envisioned a quarter century ago the

[[Page S9854]]

magnitude of savings and the significant boost to new drug innovation 
that this bill has delivered.
  According to a May 2009 report of IMS data, the use of FDA-approved 
generic medicines has saved the U.S. healthcare system approximately 
$734 billion over the past 10 years.
  Moreover, patients around the world can get needed medication that 
they would not be able to afford except for access to lower-cost 
generics.
  At the same time, price competition from generics has acted to spur a 
dramatic increase in new drug research and development.
  In short, the Hatch-Waxman Act has delivered above and beyond the 
intended result.
  I urge my colleagues to view the success of this landmark legislation 
as an indicator of what we can accomplish in the field of biologic 
medicines.
  Biologics are the most promising treatments available for diseases 
such as cancer, multiple sclerosis, and Alzheimer's, but they are 
expensive, often costing between $20,000 and $100,000 a year.
  There is no explicit pathway for Food and Drug Administration 
approval of generic versions of these medicines under the Hatch-Waxman 
law; however, there is bipartisan agreement that we need to create one. 
To do that, we need to focus on our goals and bridge our differences.
  The time to do that is now.
  Biologic drugs are the fast growing component of prescription drug 
spending.
  These drugs are expected to make up 50 percent of the pharmaceutical 
marketplace by 2020, but their high prices keep them out of reach for 
far too many patients and place an increasingly heavy financial burden 
on consumers, on businesses, and on taxpayers.
  In 2007, the top six biologics accounted for more than $7 billion of 
the nearly $17 billion in direct prescription drug spending by 
Medicare.
  That figure will continue to grow, and the amount taxpayers pay 
depends on whether Medicare can access lower-priced biogenerics or is 
forced to pay brand-name prices year after year after year.
  Biogenerics hold the promise of making life-saving medicines 
available to all patients at an affordable cost.
  With the explosion in biologics, we have a new generation of 
lifesaving medicines--and a new opportunity to reprise the historic 
victory Senator Orrin Hatch and Representative Henry Waxman achieved 25 
years ago today.
  With biologic use and prices spiraling upward, we have no: time to 
lose.

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