Friday, New Jersey attorneys filed a lawsuit seeking a shutdown of three pharmaceutical plants run by Actavis Group (an Iceland-based company) until they meet FDA testing and manufacturing laws. According to the suit, Actavis subsidiaries Actavis Inc. and Actavis Totowa LLC have been shirking numerous FDA drug safety regulations, as well as manufacturing unapproved drugs.
The lawsuit, filed by United States Attorney for the District of New Jersey Christopher Christie and the US Department of Justice, claims that Actavis plants in Totowa and Little Falls, New Jersey, despite repeatedly failing FDA inspections, have not made requisite improvements to their production processes.
Last April, Actavis was forced to recall its heart drug Digitek because some of the tablets (also called digoxin tablets, USP) accidentally contained twice the medication they were supposed to, not only doubling the dosage but increasing the risk of side effects for anyone who took the medication. At the time, Digitek was sold by Mylan Pharmaceuticals under the label “Bertek,” and by UDL Laboratories, Inc. under the label “UDL.”
Each of the five times FDA inspected Actavis labs between January 2006 and May 2008, it found shoddy testing data record keeping as well as evidence that the company was not testing its drugs under the same conditions in which consumers would use them. The company was also not making sure that its test samples met its own specifications, was not following stability testing procedures, and was neglecting to investigate unusual test results. To add insult to injury, its quality control teams were not following written procedures or making sure that testing abnormalities or other issues were resolved before the drugs went on the market.
According to the suit, Actavis was also manufacturing certain drugs in the Little Falls, NJ facility that were not even FDA-approved.
Actavis has issued a press release saying that the company has been trying to comply with FDA regulations since May 2008, and believes it will ultimately meet or even exceed these regulations. According to Actavis, it invited FDA inspectors to re-examine its manufacturing plants in October 2008, but that the agency has yet to visit.
Sounds to me like Actavis might benefit from a little time-out. We can’t allow drugs from failing, clumsy facilities to keep going on the market and hurting people because they’re made incorrectly. Why the FDA didn’t act sooner itself to close these plants is what I’m having a hard time understanding. It is gratifying, however, to see a Republican US attorney take action against drug companies that violate the law.
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