State of Connecticut Medicaid Program to Receive Part of GSK Settlement

GlaxoSmithKline will pay Connecticut $1.72 million as part of a larger nationwide settlement related to selling tainted, sub-standard and defective prescription drugs.

Related to a post earlier this week regarding GSK's huge financial settlement, the money will be paid to Connecticut's Medicaid program as a small fraction of a $750 million overall settlement.

"GlaxoSmithKline's dumping of defective drugs on Connecticut Medicaid recipients is shocking and shameful," said Attorney General Richard Blumenthal. "Such a massive failure to follow formulation and sanitation standards is unacceptable and inexplicable. The company endangered patient health -- and pumped up profits -- by providing tainted tablets."

GlaxoSmithKline allegedly sold four drugs to Medicaid that were contaminated at the company's plant in Cidra, Puerto Rico. Those drugs were:

-Paxil CR, an antidepressant that had either no active ingredient or only the active ingredient without the controlled-release aspects of the pill.

-Avandament, a diabetes medication that had too much or too little of the active ingredient.

-Kytil, an anti-nausea drug that had some impurities.

-Bactroban, antibiotic ointments and creams that contained microorganisms.

The company's head of global litigation, Elpidio Villarreal, said, "We regret that we operated the Cidra facility in a manner that was inconsistent with current Good Manufacturing Practice requirements and with GSK's commitment to manufacturing quality. 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."

Secure Pharma Chain is noticing an influx of quality control or poor manufacturing issues that are not just related to overseas contract manufacturing.

The dangers that these incidents pose to consumers all over the globe are serious and significant.

It is important that all members of the pharmaceutical supply chain authenticate and verify the quality and efficacy of their inventories to avoid liability and to protect their individual brands.

To learn more about pharmaceutical authentication technologies, visit: http://www.xstreamsystems.net/.

New York Times: Glaxo to Pay $750M for Sale of Bad Products

Regulators say that GlaxoSmithKline, the British drug giant, knowingly sold tainted baby ointment, an ineffective antidepressant and contaminated drugs.

In an article written by Gardiner Harris and Duff Wilson which appeared in the New York Times-GlaxoSmithKline, the drug giant, has agreed to pay $750 million to settle criminal and civil complaints that the company for years knowingly sold contaminated baby ointment and an ineffective antidepressant.

The following are the highlights from the New York Times article:

• This settlement is the latest in a growing number of whistle-blower lawsuits that drug makers have settled with multimillion-dollar fines.

• Altogether, GlaxoSmithKline sold 20 drugs with questionable safety that were made at a huge plant in Puerto Rico that for years was rife with contamination.

• Cheryl D. Eckard, the company’s quality manager, asserted in her whistle-blower suit that she had warned Glaxo of the problems but the company fired her instead of addressing them.

• Among the drugs affected were Paxil, an antidepressant; Bactroban, an ointment; Avandia, a troubled diabetes drug; Coreg, a heart drug; and Tagamet, an acid reflex drug.

• No patients were known to have been sickened, although such cases would be difficult to trace.

This is the latest in a string of quality control issues at pharmaceutical manufacturers both domestically and abroad.

Most troubling is that the contamination's impact to consumers is difficult to trace. No one can be certain if bad product may have had a significant or even lethal impact on its consumer.

While the financial settlements to GSK and others is large, overiding these amounts is the cost to their brands in lost trust and consumer confidence.

It is critical that all members of the pharmaceutical supply chain utilize technologies to protect their products, inventories and ultimately the consumer from poor quality, adulteration, fraud and counterfeiting.

To read the entire New York Times article, visit: http://www.nytimes.com/2010/10/27/business/27drug.html?_r=1&th&emc=th

To learn more about pharmaceutical authentication solutions, visit: http://www.xstreamsystems.net/.