A whistleblower suit alleging product mix-ups, microbial contamination and other violations of good manufacturing practice at GlaxoSmithKline's former Cidra, Puerto Rico manufacturing plant led to the company's $750 million settlement with the Department of Justice.

The Massachusetts U.S. Attorney's Office announced the settlement, which includes a $150 million criminal fine for release of adulterated products into interstate commerce, at an Oct. 26 press conference at the U.S. courthouse in Boston. Assistant Attorney General Tony West was joined by government officials from DoJ, HHS, FDA and the FBI.

West said the settlement is the fourth largest amount ever paid by a pharmaceutical company to the United States to resolve criminal and civil allegations relating to the manufacturing and sale of adulterated drugs.

"Whether drugs are contaminated during the manufacturing process, lack the proper mix of ingredients, or are mixed up and put in the wrong bottles, the consequences can be very real," West said in prepared remarks. When it comes to the sort of conduct at issue here, "we will hold pharmaceutical companies accountable."

The adulterated products include the injectable anti-nausea drug Kytril (granisetron), the anti-infective ointment Bactroban (mupirocin), the antidepressant Paxil CR (paroxetine) and the diabetes drug Avandamet (metformin/rosiglitazone) which were manufactured at the plant between 2001 and 2005.

In addition to the criminal fine GSK also agreed to pay $600 million to the federal government and states to resolve claims it caused false claims to be submitted to government health care programs for these four products. The federal share is $436.4 million while the states participating in the agreement will receive $163.6 million.

The civil settlement resolved a qui tam, or whistleblower, suit brought under the False Claims Act, which permits private citizens to file actions on behalf of the government and share in any recovery. Whistleblower Cheryl Eckard, a former manager of global quality assurance who worked for GSK from 1992 through 2003, will receive $96 million of the federal settlement amount.

First False Claims Act Case Alleging cGMP Violations

GSK will enter a corporate integrity agreement with HHS' Office of Inspector General as part of the settlement but the company said it is continuing to negotiate the terms of that agreement.

The agreement is the latest in a string of pharmaceutical healthcare fraud settlements. But while the others primarily involve allegations of off-label promotion and kickbacks the GSK settlement is the first based on a False Claims Act suit alleging cGMP violations. A DoJ official noted at a conference last year that the government would be using the statute in this arena (Also see "DOJ To Expand Use Of False Claims Act To Manufacturing And AER Violations" - Pink Sheet, 16 November, 2009.).

"We regret that we operated the Cidra facility in a manner that was inconsistent with current good manufacturing practice (cGMP) requirements and with GSK's commitment to manufacturing quality," GSK said in a statement. "GSK worked hard to resolve fully the manufacturing issues at the Cidra facility prior to its closure in 2009 and we are committed to continuous improvement in our manufacturing processes."

GSK announced in July that it would record a $2.36 billion legal charge in the second court to resolve several litigation matters, including $750 million to settle the government investigation of its Puerto Rico plant Also see "Ripping The Bandage Off: GSK Resolves Suits On Many Products For $2.3 Bil." - Pink Sheet, 19 July, 2010.).

Government Cites Product Mix-ups, Microbial Contamination

The government intervened in Eckard's whistleblower suit against GSK and its Cidra subsidiary SB Pharmco Puerto Rico. The complaint alleges that in 2001 SB Pharmco released Bactroban ointment in interstate commerce even though it was contaminated with the organism pseudomonas fluorescens. The compliant says Bactorban and Kytril were deemed adulterated because the manufacturing processes and laboratory testing were insufficient to assure their quality and purity.

The complaint also cites split Paxil CR tablets, in which the active ingredient layer separated from the inactive ingredient, or barrier layer. The complaint said SB Pharmco classified the split tablet as a "critical defect" with "a high probability of causing adverse consequences to the patient or consumer" and responded by performing 100 percent visual inspection in an attempt to remove the split tablets.

"As SB Pharmco knew, visual inspection of millions of tablets by human operators was subject to error as a result of the quality of the operator's depth perception, speed of the conveyor belt, and other environmental and human conditions," the complaint states.

The complaint further alleges that the company failed to report the defect to FDA and that after the agency cited it in 2004 for failing to take corrective action the company released adulterated lots of Paxil CR.

Among other violations, the government cites field alert reports of product mix-ups during the manufacturing and packing process. Eckard's third amended complaint alleged that the Cidra facility had received complaints that consumers had found tablets of a different drug type or different strength in the same bottle. The complaint said an internal investigation identified Avandia (rosiglitazone) mixed with Tagamet (cimetidine) and Paxil mixed with Avandia, among other mix-ups.

-Brenda Sandburg (b.sandburg@elsevier.com)

GMP Violations At GSK's Former Puerto Rico Plant Are Basis Of $750 Million DoJ Settlement

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