If GlaxoSmithKine had a records retention schedule which they maintained and enforced, guess which embarrassing documents would not be coming to light in the Paxil litigation?
- 12-year old memo of possible toxicology tests that if they turned out negative, GSK would want to bury
- 29-year old preclinical report with its possible speculations now taken out of context for a jury ready to believe the executives "should have known better"
- 15-year old regulatory affairs report of possible additional safety studies required for any eventual Japanese approval - again, such speculation has been taken out of context
Not a single one of these or any other related documents, memos, emails, presentations, meeting agendas and minutes are required to have been retained this long - if retained at all - by any regulation or statute.
And yet GSK did keep them. And now the public and the first Paxil jury has gotten the early impression - so hard to dismiss - that GSK knew better and just preferred to follow the money, not the science.
For those of you still don't grasp the impact of this, GSK faces 600+ more lawsuits on Paxil. Because of these discoveries by the plaintiffs, GSK will not be allowed to toss a SINGLE document, email, presentation, meeting agenda, sticky note, budget, and so on even tangentially related to Paxil - for at least the next 10 years. Every email that GSK employees write about Paxil, any of the court cases, or even the public perception of these trials will be subject to review and publication by plaintiff's lawyers.
If you want to see your career ruined, your budgets trashed, and your best people leave your company, the best thing you can do is follow in GSK's footsteps. Skip the records retention schedule and policies. Just keep everything.
Oh...there is one thing you'll want to do differently, but you don't have much more control over it than crossing your fingers - don't get sued or investigated by the government.
Assuming that last one is just a bit too far for you, then what should you do?
How to Avoid a Mess during Litigation or Investigations
You need to put in place an FDA compliant records retention schedule with supporting policies and SOPs, with training, enforcement, and periodic review to ensure continual improvement.
Sounds like part of any good quality system ... and it is ... at least according to FDA official Deb Autor, who said several years ago, "Companies need to train their personnel on good records handling practices."
Keeping everything is not good records handling. That's called hoarding. It's good for things like gold coins, silver ingots, and even canned goods. It's not good for records, documents, and emails.
This year, I published a 11-step article on putting in place a records retention schedule that meets FDA standards and requirements, How to Meet Compliance and Records Requirements of the US FDA.
I've done a significant amount of public speaking and corporate workshops on the same topic plus how to put in place a "discovery" strategy (e.g., what to do with your records and your retention policies when you get sued). You can get the recorded version of one of my webinars on my website, under my compliance seminars and toolkits and the title FDA Quality Systems Records Requirements and Retention for Pharmaceutical, Biotech and Device Firms - GLPs, GCPs, GMPs (I did a similar teleconference for FOI Services earlier this year as well, so you can buy the basic audio version too).
The sooner you put in place a records retention schedule with appropriate policies, enforcement and management reviews, the sooner your quality system will be in compliance and your litigation risks will be lower.
What are you waiting for?
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