[Congressional Record Volume 148, Number 56 (Tuesday, May 7, 2002)]
[House]
[Page H2110]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




THIS YEAR CONGRESS SHOULD PASS AND THE PRESIDENT SHOULD SIGN H.R. 1862, 
        GREATER ACCESS TO AFFORDABLE PHARMACEUTICALS ACT OF 2001

  The SPEAKER pro tempore. Pursuant to the order of the House of 
January 23, 2002, the gentleman from Ohio (Mr. Brown) is recognized 
during morning hour debates for 5 minutes.
  Mr. BROWN of Ohio. Mr. Speaker, when large employers, unions, and 
progressive Members of Congress and governors and senior groups and 
consumer advocates join forces on the same issue, Congress listens. 
What is the issue? Prescription drugs and prescription drug prices. 
What is the remedy? Legislation pending in the Senate and House that 
would close loopholes in the Waxman-Hatch bill Congress passed in 1984.
  Overall, the law, which was intended to help consumers gain access to 
blockbuster drugs and to, eventually, lower-cost generics, has worked 
well. Waxman-Hatch ensured brand name manufacturers almost 2 decades of 
patent protection, promoting important innovation and ensuring huge 
profits for the prescription drug industry.
  Between 1983 and 1995, drug companies increased their R&D investment, 
in large part because of Waxman-Hatch, from 14 percent to 19 percent of 
sales. They earned quite a healthy profit on that investment. U.S. 
pharmaceutical sales rose 200 percent, from $17 billion to $57 billion. 
The act streamlined the generic drug approval process to help bring 
lower-cost prescription drugs to the market. Last year, generic drugs 
accounted for 42 percent of all prescriptions dispensed.
  But the big drug companies have been greedy; smart, but greedy. The 
industry has perfected the practice of attaching questionable patents 
to their drugs for the purpose of preventing generic drugs' entry into 
the market. As a brand drug nears the end of its 20-year patent life, 
the company will file what they deem a ``new and improved patent'' on 
the same drug, to keep out the generic drug and to keep out 
competition.
  A patent, for example, was filed on a pill that could be divided into 
three parts instead of in half, instead of in two parts. This new and 
improved patent pill, patented pill, that does not affect the way the 
pill metabolizes in the body, which is what matters, keeps the generic 
drug that can be divided in half off of the market. While the generic 
company fights this outrageous patent in court, the brand name company, 
the big drug company, retains its market exclusivity at the cost of 
tens of millions, sometimes even billions of dollars, to consumers. The 
drug industry manipulates the law with relative ease.
  I will share another example. Neurontin is a prescription drug for 
seizures. Its two main patents, one on the drug's ingredients and one 
on the use of the drug, expired in 1994 and in 2000. Right before the 
second patent expired, the company listed two new patents, one of which 
was on an unapproved FDA use to treat Parkinson's disease.
  The industry did not ask the FDA to approve the drug for use in 
Parkinson's patients. The industry did not do any research to assert 
whether the drug actually is effective in Parkinson's patients. But the 
drug company, the generic drug company, the competitor that forces 
prices down, that would compete with the name brand company, the 
generic drug company still had to go to court to argue that its generic 
drug is not intended for use for Parkinson's patients.
  When the generic and the brand name company go to court, the FDA is 
automatically required, must be required to withhold approval of the 
generic for 30 months, 2\1/2\ years. After those 30 months, the 
industry filed a new patent, forcing the generic industry to go back to 
court, starting the 30-month clock over.
  The two delays in the case of Neurontin, the two delays, equalling 5 
years, delayed generic access to the market, delayed consumers getting 
the less expensive drug, delayed the marketplace competition, and it 
cost consumers $1.5 million every day because of the big drug 
companies' greed. Industry profits continue to soar.
  Now a group of large corporations, labor unions, governors from both 
sides of the aisle, and consumer groups want to stop the patent abuses. 
Unfortunately, Republican leadership does not. All of us know that 
loopholes in the law are contributing to spiraling prescription drug 
costs and that this level of spending is unattainable.
  The gentlewoman from Missouri (Mrs. Emerson) and I have introduced 
legislation, H.R. 1862, to close the loopholes and to release the 
billions in consumer savings that are being stifled by the big name 
drug companies and by Republican leadership.
  General Motors supports our legislation, and so do the United Auto 
Workers. Verizon and the other Baby Bells support our legislation, and 
so do the Communication Workers of America. The AARP supports it, the 
AFL-CIO supports it, and Governor Deane from Vermont, a Democrat, 
Governor Foster from Louisiana, a Republican, supports it. The only 
people who do not are the Republican leadership in the House.
  Congress should pass this legislation and the President should sign 
it this year. Tens of billions of dollars, consumer dollars, are at 
stake.

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