[Congressional Record (Bound Edition), Volume 155 (2009), Part 18]
[Extensions of Remarks]
[Page 24520]
[From the U.S. Government Publishing Office, www.gpo.gov]




        INTRODUCING H.R. __, DRUG PRICE COMPETITION ACT OF 2009

                                 ______
                                 

                         HON. ALCEE L. HASTINGS

                               of florida

                    in the house of representatives

                       Thursday, October 8, 2009

  Mr. HASTINGS of Florida. Madam Speaker, I rise today to introduce the 
Drug Price Competition Act of 2009, a bill that will help achieve some 
of the goals that are essential to health care reform: ensuring fair 
market competition and increasing access to affordable drugs.
  State-of-the-art drugs have undoubtedly improved and saved lives, and 
consumer demand for these drugs has certainly posed an economic burden 
on countless Americans. Although prescription drugs account for 10 
percent of total health care expenditures, it is one of the fastest-
growing segments within health care spending. Consumers are not the 
only ones who face the cost of prescription drugs. The federal 
government is now the largest purchaser of drugs in the United States 
and accounts for roughly two-fifths of the drug consumer market.
  Generic drugs cost between 80-85 percent less than brand name drugs 
and comprise 70 percent of all drug prescriptions that are filled in 
the United States today. Many have acknowledged the role that generics 
have played in alleviating the burden of prescription drug costs on 
individual and government health care spending. The Hatch-Waxman Act of 
1984 established a pathway for generic drugs to receive approval from 
the Food and Drug Administration, FDA, and enter the consumer market. 
However, some generic and brand name drug companies have exploited a 
flaw in this Act and have restricted access to generics.
  Under the Hatch-Waxman Act, the first drug company that submits an 
application for product approval to the FDA receives a 180-day period 
of exclusivity in which no other generic company is allowed to enter 
the market. This application is also accompanied with a challenge to 
the brand company's drug patent. In response, brand companies often pay 
generic companies large sums of money to encourage them to postpone 
their entry into the market.
  Generic drug companies frequently comply because they can retain 
their 180-day period of exclusivity even if they agree to enter the 
market years later than was first anticipated. Additionally, generic 
manufactures that were not the first-to-file have no incentive to 
challenge the brand company's patent and potentially open the blocked 
markets because they would not be able to enter the market until after 
the 180-day exclusivity period.
  Madam Speaker, the Drug Price Competition Act of 2009 is a House 
companion to a bill that Senator Bill Nelson of Florida introduced 
earlier this year. The bill targets the root of the blocked drug market 
problem. It allows generic companies that win patent challenges to 
share the 180-day exclusivity period with the generic companies that 
first submitted an application to the FDA. However, no subsequent 
challenger would be eligible to share in the exclusivity reward once 
the generic drug has been launched.
  If enacted, first-to-file generic manufactures would be less likely 
to accept a late entry date because this would mean that another 
generic manufacturer could win a patent challenge and share the 180-day 
exclusivity period.
  Madam Speaker, generic medications are critical to managing 
everything from heart disease to battling life-threatening cancer. 
Stymied market competition and delayed access to generic medication 
pose serious health and economic costs to patients and taxpayers. The 
Drug Price Competition Act of 2009 will effectively correct the 
systemic flaw in the Hatch- Waxman Act that has blocked price 
competition, and increase access to affordable life-saving medications. 
I urge my colleagues to support this important bill that takes a fair 
market and cost-saving approach to improving our health care system.

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