By Daniel R. Matlis
The Food and Drug Administration (FDA) announced that it has asked pharmaceutical companies to confirm or repeat all pharmacokinetic studies conducted for them by MDS Pharma Services (MDS Pharma) from 2000 through 2004.
MDS Pharma performed pharmacokinetic testing services for a number of pharmaceutical companies. These studies are used to measure the level of drug in a patient’s blood. The results of these studies are required for the approval of a drug by the FDA.
The action is a result of FDA inspections of two MDS Pharma Canadian facilities that raised questions about the validity and accuracy of test results from studies conducted by MDS Pharma from 2000 through 2004. FDA has worked with MDS Pharma to address these issues concerning its test results and is now following up directly with all pharmaceutical companies with marketed drugs or pending drug applications that may be affected by these testing issues.
The Agency sent over 1,000 letters to sponsors of pharmaceutical products for both brand-name and generic drugs
As you can imagine, drug companies affected by this notification want to review these studies as expeditiously as possible. However in some cases it may take weeks to just find the study data, let alone review and analyze it.
Why, you ask?
Some of these studies are six years old and are most likely collecting dust at archive facilities like Iron Mountain, or if you are lucky they are on a backup tape in a vault.
In either case it will take hours, days and in some cases weeks to find the right box or tape, retrieve it, parse it and find the pharmacokinetic study in question. Only then will scientists be able to analyze the impact of the study on the drug and the patients.
According to a recent article, the amount of data required to support compliance activities in the Life-Sciences Industry has increased by 400% from 376 PetaBytes in 2003 to 1644 PetaBytes in 2006 (a PetaByte equals one quadrillion bytes). This data is in Data Islands often connected by Sneaker-net across the enterprise.
This incident highlights the need for our industry to implement technologies that not only ensure that data is stored, archived and protected, but more importantly can be quickly and reliably retrieved to meet ever increasing business, regulatory and litigation discovery requirement.