The US Department of Justice (DOJ) is seeking a permanent injunction to prevent Actavis Totowa (Totowa, NJ) and Actavis (Hafnarfjordur, Iceland), its parent company, from manufacturing and distributing generic drugs. The government is taking this dramatic step after the company repeatedly violated good manufacturing practice (GMP).
In the course of five inspections throughout the past three years, the US Food and Drug Administration found “numerous and recurring violations of [GMP] requirements” at Actavis Totowa’s facilities, according to a DOJ press release. FDA sent the company several Warning Letters during this time, but violations continued.
The GMP violations resulted in potentially dangerous products and prompted the company to initiate three recalls (of digoxin tablets, fentanyl patches, and all products manufactured at its Little Falls, NJ facility) by August 2008. For example, FDA found that GMP failures resulted in digoxin tablets that were twice the appropriate thickness, and potentially twice the appropriate strength. Actavis released these tablets to the market even after it had discovered the problem.
On top of the GMP violations, FDA warned Actavis against producing products containing ergotamine tartrate, which the agency considered an unapproved new drug. Despite the warning, FDA found that the company continued to manufacture these unapproved products, according to DOJ’s press release.
I believe DOJ’s measure is justified. Actavis’s repeated GMP violations, despite FDA warnings, unduly jeopardized consumers’ health. Manufacturing unapproved drug products also circumvents the regulatory structure designed to ensure public safety. DOJ’s action is an encouraging sign that the government takes its charge of protecting the public seriously.