Actavis agrees deal with FDA on manufacturing problems
pharmafile | January 9, 2009 | News story | Manufacturing and Production | Actavis
Generic drug manufacturer Actavis will continue the lockdown of its New Jersey manufacturing facilities that breached quality standards, but hopes to request a re-inspection soon.
In April an FDA inspection revealed numerous deviations from Good Manufacturing Practice standards at the facilities. The most serious was a quality control failure, which allowed double-strength batches of heart treatment Digitek (digoxin) to be shipped for distribution.
Actavis was forced to implement a Class I, nationwide recall of Digitek. The errors have hit the company's US business hard, not only affecting sales but sparking litigation from patients claiming they have been harmed by the drug.
Then in August Actavis extended its product recall to all of those made at the facilities after an FDA investigation.
A few weeks after the August recall, Actavis applied to restart production, but this was met with a lawsuit filed by the US Department of Justice, seeking an injunction to keep the facilities closed.
Actavis has agreed to keep plant operated by its Totowa subsidiary closed until the FDA inspectors are satisfied that procedures there have improved.
The units affected are two oral-dose manufacturing sites in Little Falls and Riverview, and a packaging facility in Taft. The company's other facilities in New Jersey and North Carolina are unaffected by the action, said an Actavis spokesperson.
The new agreement, called a 'Consent Decree', has now settled the matter, according to Actavis.
The spokesperson told Pharmafocus that the next stage is for the judge overseeing the case to sign the Consent Decree, which will allow Actavis to issue a formal request for a re-inspection of the plants by the FDA. Production will be able to start once that re-inspection is passed.
Meanwhile, Actavis is facing dozens of lawsuits from patients claiming to have been injured by oversize Digitek tablets, although the spokesperson claimed that there is "no evidence at this point" that the compromised product reached patients.
Last month, US consumer organisation the Center for Public Integrity said it had conducted an analysis showing a spike in cases of digoxin-related adverse reactions between April and June, with 667 deaths in that period attributed to the drug compared to one in the previous quarter.
The spokesperson declined to comment on those figures in light of pending litigation, other than to say an increase in adverse event reporting would be expected in the period following a Class I drug recall.
Actavis chief legal officer John LaRocca said the company had been working closely with the FDA on finding a solution to the problems.
He added: "We have an entirely new management team in place at Little Falls and have invested significantly to reinforce systems and procedures intended to better ensure robust, sustainable compliance.
"This agreement with the Agency is a positive step and is one we have looked forward to reaching. We will continue to work with the FDA to show that we have addressed all of the agency's compliance and manufacturing issues."
Actavis had already hired the consultancy arm of Parexel, to independently assess the facilities. Parexel's GMP experts will continue to work with Actavis to prepare the facility for its re-inspection by the FDA.
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