Puerto Rican plant’s blunders include manufacturing antidepressant with no active ingredient.
GlaxoSmithKline (GSK) is paying the U.S. government $750 million in settlement of civil and criminal charges relating to the manufacture and sale of substandard or contaminated drugs, says Getnick & Getnick, the law firm that filed a whistleblower lawsuit on behalf of an ex-GSK employee back in 2004. The overall payment by GSK includes $600 million in settlement of civil charges and another $150 million in criminal fines.
The charges relate to manufacturing practices from as far back as 2002 at GSK’s plant at Cidra in Puerto Rico. GSK points out the Cidra plant was closed in 2009 due to “declining demand for the medicines made there.” The firm no longer owns the site.
The whistleblower lawsuit was initiated by a former GSK quality assurance manager Cheryl Eckard, her law firm explains. Eckard’s team was first sent to the Cidra factory in 2002 to address manufacturing violations already cited by FDA. At that time the Cidra plant was GSK’s top producer, manufacturing over 20 products worth some $5.5 billion annually, including the blockbuster drugs Avandia, Paxil, and Coreg.
Eckard’s team found that the true scale of problems at Cidra went far beyond that already uncovered by FDA, her lawyers claim. The actual range of manufacturing issues included mixed-up products, contaminated water systems, and air-handling systems that misdirected the flow of product powder. Retnick & Retnick says Eckard was fired by GSK in 2003 after repeatedly complaining about conditions at the Puerto Rico plant.
A year after the subsequent whistleblower lawsuit was filed, FDA seized all GSK’s stocks of Avandamet and Paxil CR, worth an estimated $2 billion, in what was the largest seizure in FDA history, the law firm adds. The Cidra facility was also placed under a Consent Decree that required the independent approval of all products prior to their release.
The agreed settlement by GSK follows six years of investigations. It covers charges that batches of GSK’s Bactroban topical antibiotic were contaminated with microorganisms and its injected antinausea drug Kytril was not sterile. The charges also cover the release of Paxil CR antidepressant tablets that actually contained no active ingredient, and batches of the diabetes drug Avandamet that were either superpotent or subpotent.
“We regret that we operated the Cidra facility in a manner that was inconsistent with current cGMP requirements and with GSK’s commitment to manufacturing quality,” remarks P.D. Villarreal, svp and head of global litigation at the firm.”GSK worked hard to resolve fully the manufacturing issues at the Cidra facility prior to its closure in 2009.”
Retnick & Retnick claims the case represents the first time that whistleblower law has been successfully applied to hold a drug maker accountable for violations of government manufacturing standards.“Drug manufacturing is vulnerable to abuse because consumers can’t see the defects,” comments Getnick & Getnick partner Lesley Ann Skillen. “As a result of this settlement and guilty plea, drug makers will now have more reason to live up to their motto that patient safety is their first priority.”