Copyright 1999 The Omaha World-Herald Company
Omaha
World-Herald
November 20, 1999, Saturday SUNRISE EDITION
SECTION: ;EDITORIAL; Pg. 24
LENGTH: 719 words
HEADLINE:
Drug Patents Need a Look
BYLINE: 2
BODY:
A key issue in the debate about the
escalating cost of pharmaceuticals is the amount of protection the developer of
a drug should expect the government to provide against competition from
lower-priced substitutes.
Prescription drug prices have risen at an
average annual rate of 12 percent since 1993, far above the rate of inflation.
Vice President Al Gore and others have laid a portion of the blame on the system
of awarding and extending drug patents, an issue that needs to be addressed by
Congress.
A patent protects a company's exclusive right to produce a
drug for 17 years. In practice, the market period is shorter than 17 years
because the clock ticks even while the manufacturer is getting the approval of
the Food and Drug Administration. But in any event, not until the 17 years
passes can other companies jump into the market with generic versions of the
protected drug.
Generic drugs are typically cheaper - generally more
than 50 percent cheaper - than their brand-name counterparts. Claritin, a
popular drug for allergies produced by Schering-Plough, costs between $ 1.88 and
$ 2.66 a pill retail. The generic equivalent, if such a thing were available,
would cost about 50 cents.
The issue pinpointed by Gore is the common
practice by drug manufacturers of going to Congress to have their 17 years
extended. This gives them extra years in which to sell their exclusive drug at a
higher price or in greater quantities than would be likely if competition
existed.
Gore has advocated legislation requiring an independent
analysis of the effects that patent extensions would have on the cost of
Medicaid and veterans programs, as well as the effect on consumers. Gore also
criticized the way Congress often passes patent extensions: by attaching them to
"larger pieces of legislation in the middle of the night." The extensions
attached to complex bills usually pass without attracting any attention.
One such request that is working its way through the process now is for
Claritin, whose patent is due to expire in 2002. Its manufacturer has requested
a three-year extension for the drug, which had sales of $ 2 billion worldwide
last year. Since 1996, the manufacturer has spent $ 4 million a year on
lobbyists hired to convince Congress to give it what it wants.
The
company also allowed Sen. Orrin Hatch, R-Utah, to use its
corporate jet in his campaign for president. The same month,
Hatch scheduled a hearing on a bill that, if passed, would have
helped smooth the way for Claritin's extension.
Rep. Henry
Waxman, D-Calif., a strong advocate of generics, called the
bill the "Claritin Monopoly Extension Act." Its passage, he said, "would send a
simple message that if you spend enough money and hire the right lobbyists you
can get a law that harms consumers."
Not surprisingly, the Senate
Judiciary Committee on Thursday postponed action on the legislation. The bill's
opponents say the committee sat on the measure because of the growing public
attention being paid to it.
Patent extensions aren't the only means used
by companies to protect their expensive medications from generic competition.
Hoescht Marion Roussel, manufacturer of the heart drug Cardizem CD, which has
sales of $ 750 million a year, paid $ 100 million to Andrx, a manufacturer of
generics, when the company decided to delay marketing its generic version of
Cardizem in order to "reformulate" it.
Congress should not hand out
patent extensions willy-nilly, certainly not by hiding them deep inside other
bills so no one will notice what has been done. The patent rules are the same
for all drugs. Extensions should be neither necessary nor common.
The
high cost of prescription drugs for consumers is made even higher by patent
extensions, payments to generic manufacturers and the other tricks manufacturers
use to extend their exclusive control over vital drugs. Pressure to do something
about that cost - by applying government controls, for instance - is rising.
With a host of new and important drugs in the research pipeline, many of
them gene-based therapies and most of them potentially expensive, the problem
shows no sign of going away. Gore has put his finger on a sore spot that needs
attention.
LOAD-DATE: November 20, 1999
