Today, the U.S. Food and Drug Administration announced that it had filed a
Consent Decree on December 23, 2008, and currently awaits the court's entry
of a permanent injunction that bars Actavis Totowa, LLC, Actavis, Inc., and
their officers, Sigurdur Oli Olafsson and Douglas Boothe, from manufacturing
and distributing drugs at the Actavis Totowa facilities. The injunction will
remain in effect until Actavis Totowa comes into compliance with U.S. current
Good Manufacturing Practice (cGMP) requirements, and obtains FDA's approval
to manufacture and distribute drugs in the United States. The companies and
their officers had also been manufacturing and distributing unapproved drugs
in the United States.
The defendants signed a consent decree that permits them to resume operations
with respect to three categories of drugs only after an expert certifies that
the drugs comply with the CGMP requirements and have FDA approval, and FDA
inspects to confirm compliance with the law. The consent decree also requires
defendants to destroy any remaining drugs that they recalled in April-July
2008, that are currently in their possession.
To
view the complete list of unapproved drugs made by Actavis Totowa see List.
The safety and effectiveness of these drugs has not been established because
the company has not submitted for FDA review and approval new drug applications
for them. FDA advises patients who have been using these products to discuss
alternative therapies with their health care provider. Pharmacists should
discontinue dispensing all unapproved drugs manufactured by Actavis Totowa.
"The FDA will not allow manufacturers to put the public's health at risk," said
Janet Woodcock, M.D., director, Center for Drug Evaluation and Research, FDA. "These
unapproved new drugs have not undergone FDA review for safety and efficacy
and may pose potential health risks."
The consent decree also authorizes FDA to order the defendants to cease operations
in the event of future violations. It further subjects the defendants to liquidated
damages of $15,000 per day if they fail to comply with any of the provisions
of the decree, and to the payment of an additional $15,000 for each violation,
up to $7 million per year.
Actavis Totowa manufactures, processes, packages, labels, holds, and distributes
drugs from two sites in Totowa, N.J., and one in Little Falls, N.J. FDA inspected
Actavis Totowa's Riverview Drive facility in Totowa from March-May 2008, and
found that the company had significant cGMP violations and continued to manufacture
unapproved drugs. As a result of this inspection, which led to this action,
Actavis Totowa recalled all products manufactured and distributed from its
three facilities. Actavis Totowa is a wholly owned subsidiary of Actavis, Inc.,
the manufacturing and marketing arm of Actavis Group hf, a generic pharmaceutical
company based in Reykjavik, Iceland.
"The FDA will carefully monitor the provisions of this injunction to
ensure compliance, said Michael Chappell, FDA acting associate commissioner,
Office of Regulatory Affairs. "Companies should know that FDA will investigate
and take action against other marketers of unapproved drugs."
The government's complaint, filed Nov. 14, 2008, by the U.S. Department of
Justice in the District Court for the District of New Jersey, alleged that
the defendants violated the Federal Food, Drug, and Cosmetic Act by not complying
with cGMP requirements and failing to obtain FDA's approval of some of
its drugs, two requirements designed to ensure the safety, effectiveness, and
quality of pharmaceutical products.
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