Claritin Maker to Pay FDA Half a Billion
Dollar Fine
By Marc
Kaufman
Drugmaker Schering-Plough Corp.
will pay the Food and Drug Administration a record $500 million as part of a
broad settlement aimed at resolving quality-control problems at four of its
factories.
The FDA said that the consent
decree covers problems found in the manufacturing of
90 percent of the company's drug products
since 1998, and involves 125 prescription and nonprescription drugs.
As part of the decree, the
company agreed to suspend manufacturing of 73 products and to pay an
additional $175 million if it falls behind in its efforts to improve
manufacturing practices. The company said consumers should remain confident
of its products, which are now under increased FDA oversight.
The action against
Schering-Plough, maker of Claritin and one
of the nation's top 10 pharmaceutical companies, is unusual in
its size but consistent with the FDA's growing concerns over questionable
manufacturing practices. Since the FDA won the authority in 1999 to go after
the profits of companies that do not comply with federal good-manufacturing
rules, the agency has reached similar though smaller settlements with
several other companies.
Agency officials said there are
alternatives to all the Schering-Plough drugs on which production will be
suspended. These include some formulations of brand-name drugs such as the
asthma medication Proventil and the decongestants Chlor-Trimeton and Afrin,
as well as generic medications such as theophylline, an asthma drug.
Recalls were initiated early
this month of the affected Proventil and theophylline, and several other
drugs were recalled over the last few years. While some consumer groups have
charged that patients were harmed by problems with Schering-Plough's asthma
drug albuterol, the company denies that. FDA officials said consumers can
safely use any Schering-Plough products they might have in their homes or
any still on store and pharmacy shelves.
The problems detected at the
four Schering-Plough plants, in New Jersey and Puerto Rico, involved
"manufacturing, quality assurance, equipment, laboratories, and packaging
and labeling," according to an FDA statement. An FDA official said the
problems had to do with the overall manufacturing practices and quality
control, and that the safety and effectiveness of individual drugs were not
necessarily compromised.
Company officials said some of
the suspended drugs will be discontinued while others will return after the
FDA approves changes in the firm's manufacturing practices.
The large settlement comes as
the FDA has grown increasingly concerned about manufacturing practices in
the pharmaceutical industry and has been pressing reluctant companies to
make improvements that agency officials believe are necessary.
Before 1999, the FDA had little
power to seek penalties against companies found to be in violation of agency
"good manufacturing practices." But a federal appeals court ruled then that
the FDA could go after the profits of companies that act improperly, and the
agency has won several large agreements since. Abbott Laboratories Inc.
agreed to pay $100 million in 1999 to settle accusations that it failed to
meet quality standards in the production of medical test kits, and Wyeth
Laboratories Inc. agreed to pay $30 million in 2000 to settle accusations of
poor manufacturing practices.
The FDA said the
Schering-Plough settlement was large because the company was out of
compliance for three years, and was highly profitable during that time.
Last year, the consumer group
Public Citizen Health Research Group called for a criminal investigation of
Schering-Plough, saying that the company
distributed albuterol asthma inhalers even though it knew the units were
missing the active ingredient. Public Citizen based its claims on
a confidential audit it says it obtained.
The company recalled inhalers
in 1999 and 2000, and Sidney Wolfe of Public Citizen said that Justice
Department officials questioned him about the contents of the audit and the
albuterol problems.
"This company for years has
grossly neglected the manufacturing of many of its products," Wolfe said.
"They were told to clean up their act years ago, but they didn't do it."
Washington Post May 18, 2002; Page A01
Another great example of how
the drug companies can’t be trusted. Even the FDA, which normally is in
collusion with the drug companies had to fine Schering half a billion
dollars.
Even that doesn’t seem fair
for the despicable action of putting money ahead of lives. How could any
company sell life saving medication, like an asthma inhaler without the
active ingredient?
Folks this was not a fly by
night firm. This is a US top ten drug company and 90% of their products had
quality assurance problems.
Really makes you wonder
about the others.
Do you really want to place
your life in the hands of people who would do this?
Take up the crusade. Start
eating better so you don’t get sick and have to take drugs. Start the
eating plan today and
encourage your friends and relatives to do likewise.
Folks we can change the
system.
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