FDA Statement Suggests Actavis Will Be Held Accountable For The Defective Digitek Pills, And Mylan Maintains That This Is Not My(lan) Problem
(Posted by Tom Lamb at DrugInjuryWatch.com)
When considering where things stand with the Digitek recall, there are a few items that seem noteworthy for various reasons.
We'll set the stage with an April 25, 2008 press release from Actavis which first announced and explained the Digitek recall:
Morristown, NJ, 25 April, 2008 - Actavis Totowa LLC, a United States manufacturing division of the international generic pharmaceutical company Actavis Group, is initiating a Class 1 nationwide recall of Digitek (digoxin tablets, USP, all strengths) for oral use. The products are distributed by Mylan Pharmaceuticals, Inc. under a "Bertek" label and by UDL Laboratories, Inc. under a "UDL" label.
The voluntary all-lot recall is due to the possibility that tablets with double the appropriate thickness may have been commercially released. These tablets may contain twice the approved level of active ingredient than is appropriate.
From there we provide a hint about Mylan Pharmaceuticals' position on the defective "double-dose" Digitek pills, which could be based on this corporate motto found on their web site (PDF image no. 4):
The company's success can be attributed to... upholding its founding corporate motto: "We either do it right or we don't do it at all."
Next comes Actavis, which manufactured the Digitek "tablets with double the appropriate thickness". On their web site Actavis tells us how drugs like Digitek should be made with this Q-and-A about the industry standards for manufacturing prescription drugs:
What does “Good Manufacturing Practices” (GMP) mean?
GMP is a regulatory guideline imposed on all manufacturers of pharmaceuticals in order to ensure compliance with quality standards such as the pharmacopeia standards, the marketing authorisation and other applicable regulatory requirements in order to ensure the quality, efficacy and safety of pharmaceuticals.
Now let's look at a more serious issue, that of accountability and liability for those defective Digitek pills. Who is the responsible party, Actavis or Mylan or both?
According to a June 12, 2008 article, "Families Suing Mylan For Medication Mistake", published by The State Journalin Charleston, West Virginia, Mylan is pointing the finger at Actavis:
Mylan Spokesman Michael Laffin said the company has a policy to not comment on pending litigation. However, following Actavis' recall announcement, he said Mylan released the following statement:
"Patient safety has always been of utmost concern for us at Mylan. We have been working with the FDA to ensure that our customers are aware of Actavis Totowa's recall of Digitek. Digitek is manufactured by Actavis and distributed by Mylan. Actavis, as the manufacturer, initiated the recall, and our expectation is that Actavis is responsible for all costs associated with it, including litigation costs. Digitek represents a very small portion of Mylan's global product portfolio."
Mylan's current position may or may not prove to be true as regards liability in civil lawsuits filed on behalf of people injured by the defective Digitek. There are indications, however, that the FDA agrees with Mylan as regards accountability in the regulatory arena.
The following is taken from "CDER’s Compliance Office Highlights Manufacturer Accountability", which was part of the June 17, 2008 FDAnews Drug Daily Bulletin:
As the FDA prepares its response to a senator’s question on how best to hold drugmakers accountable for drug quality, CDER’s Office of Compliance is highlighting the agency’s efforts to examine the drug supply chain, reiterating regulations that the NDA holder is responsible.
“Ultimately the dosage form manufacturer with its name on the label is responsible,” the Office of Compliance said. “Our regulatory structure under the [Food, Drug and Cosmetic] Act, and implementing regulations, provide for the identity, strength, quality and purity of the drug and the prohibited acts provide for civil sanctions and criminal penalties for failure to do so.” ...
Sen. Sherrod Brown (D-Ohio) asked CDER Director Janet Woodcock how best to hold pharmaceutical manufacturers accountable for lapses in drug quality as a follow-up to a Senate hearing on the heparin contamination. During that hearing, Woodcock testified that the best means for ensuring product quality is to hold industry accountable for selling contaminated product.
Since the time when this Digitek recall was announced in late April 2008 there has been not much, if any, information released by Actavis, Mylan, nor the FDA about what went wrong, and when, at the Actavis Totowa manufacturing plant in New Jersey.
Once the cause and extent of the Digitek manufacturing problem are determined the Actavis, Mylan, and the FDA, that information should be made public. Likewise, the FDA should tell us when it takes regulatory action -- civil sanctions and/or criminal penalties? -- concerning this Digitek recall and whether it is against Actavis or Mylan or both.