Copyright 1999 Federal News Service, Inc.
Federal News Service
AUGUST 4, 1999, WEDNESDAY
SECTION: IN THE NEWS
LENGTH:
384 words
HEADLINE: PREPARED STATEMENT OF
SENATOR
EDWARD M. KENNEDY
BEFORE THE SENATE JUDICIARY COMMITTEE
SUBJECT - PIPELINE DRUGS: PROPOSED REMEDIES FOR RELIEF
BODY:
Today, the Committee hears testimony
about proposed changes to one of the most important health laws - the Drug Price
Competition and Patent Term Restoration Act of 1984 the
Hatch-Waxman Act, which has had an effective role in improving
public health in America. The Act has enhanced research and development by
pharmaceutical companies and encouraged the growth of the generic drug industry,
which ensures affordable prescription drugs for patients at all income levels.
The law, which has now been on the books for 15 years, streamlined the
approval process for generic drugs, and allowed generic drug firms to make plans
to enter the market before a brand-name drug's patent expires. It also gave
brand-name pharmaceutical firms an extension on their patents to accommodate the
often lengthy regulatory delays, so that research and development costs can be
fairly recouped. The law strikes a balance between major interests on both sides
and has served the nation well for many years. Congress must carefully consider
any proposed changes to ensure that the balance is preserved. S. 1172, the Drug
Patent Term Restoration Review Procedure Act of 1999 proposes to amend the Act
to provide greater patent term extension for so-called "pipeline drugs" - drugs
under consideration by the FDA when the Act became law. Proponents of the
legislation believe it is necessary to ensure parity and fairness for such drugs
- some of which currently reap millions of dollars -- even billions of dollars -
in revenue every year.
Opponents of this legislation argue that it is
unnecessary and unwarranted. They believe the process proposed in S.1172 will
only create a larger bureaucracy and add to the cost of health care for millions
of Americans. They also argue that it will do relatively little to remove
Congress from the annual, end-of-the-year rush to provide patent term extensions
for individual drugs, a process that many of us find particularly disturbing.
Before Congress takes action, we must ensure that patients are the
beneficiaries. The careful balance that provides for research and development,
and for affordable prescription drugs must be maintained. I look forward to
today's testimony and to working with other members of the Committee on this
important health issue.
END
LOAD-DATE: August
5, 1999 
