Compliance Zen

October SmarterCompliance Newsletter Available

My October SmarterCompliance newsletter has been published; download the trial version of my FDA regulatory intelligence and quality systems advice newsletter until mid-November.

In the October newsletter:

• Two FDA officials on supplier management controls
• Crafting self-enforcement compliance policies and SOPs
• Recent 483s and warning letter analyses - FDA sterilization findings
• Leadership tactics: Driving decisions in meetings
• Featured reading: Fierce Leadership

You can a lot more content and bonus downloads with a full subscription to my monthly FDA newsletter here:   http://www.ceruleanllc.com/Newsletter/Subscribe.htm

Join my Cerulean mailing list here:  http://www.ceruleanllc.com/ContactReq.aspx

What I Like about NICE

After reading an interview with Kalipso Chalkidou, director of the international division of the UK's National Institute of Health and Clinical Excellence (NICE), I was reminded what I like about NICE:  its emphasis on trying to handle the cold realities facing us all.  NICE is not loved by the biopharmaceutical industry and I don't blame the industry - I'd be frustrated too if I spent an average $1.2 billion USD to bring a new product to market only to see NICE review it and say, "Naaaah."

Unfortunately, getting mad at NICE is not going to solve the issue.  And that issue is one that came up earlier this year when I spoke at an National Institutes of Health (NIH) function:  how to drive down medicinal product cost while improving innovation.

What I like about NICE is that it reminds me to keep myself grounded in the big picture when it comes to future drug, biologic and device development and trying to contain costs while improving innovation.

NICE reminds me that before I sink $1.2 billion into developing a new medicine, maybe I should find out what the market will bear first.  In other words, NICE reminds me to do my homework; that I can't just follow the science.  That I have to balance science with business; that there is, ultimately, no real difference between the need to balance the books of a business that makes medicines and the books of a business that makes toasters.  Both businesses need products that customers want AND are willing to pay for.

Sounds so simple until you realize two little hitches:

1. The toaster business owner knows his customer is either the person shopping for a home toaster or the person shopping for a commercial toaster (like in a cafe) - medicinal product companies worry about that toaster-shopper plus his/her doctor plus his/her insurer.


2. The toaster business needs to worry about the same regulations that a medical products company does with one difference:  regulatory health agencies (e.g., FDA, NICE, CHMP, EMEA, etc.) - no easy task there.

NICE, Innovation and Effectiveness

As many of you know, I'm working on a book for Logos Press on the role of regulatory compliance departments (Regulatory Affairs teams, Quality groups, Compliance officers, etc.) in fostering new medicine innovation, lowering costs, and improving marketplace success.

Inherent in product innovation is the ability to adopt tenets of new product development innovation like Quality by Design as early as possible in the medicinal development pipeline.  In other words, to know before you spend $1.2 billion - and preferably way before you spend even close to that - whether or not a new drug, biologic or device has a chance not only of FDA approval but of a good reimbursement rate.

As NICE shows us, getting your medicine approved by the FDA or EMEA as safe no longer equals getting your medicine purchased.  Your medicine has to be effective.  And people tend to measure tangible effectiveness (not just statistical significance) with something they know - their pocketbooks:  are they or are they not getting their money's worth?

NICE and Game Theory

If you like game theory - that cynical philosophy that says people tend to act in their self-interest - then you have to at least appreciate NICE.

NICE is simply saying, "Look, just as with all other things in life, so it is with medicines and reimbursement:  at some point, you reach a matter of dwindling returns.  We don't have all the money in the world to buy all the medicines in the world for each of us - there is only so much to go around."  NICE is trying to act in the insurer's best interest and the best interests of all the people covered the insurer (in this case, the UK government is the insurer).

And so we again come to what I like about NICE:  it reminds us to think about the big picture; to remember that ultimately medicine isn't just about curing disease and saving lives, it's about making those extra moments or months or years of life worth the medicine's expense.  It's about ensuring the self-interests of not just the individual patient and the biopharmaceutical maker are served, but so are the interests of all the other prospective patients, the interests of all the other insured, and the interests of the insurer.

My own career experiences and those of my clients over the years have shown that if you can simplify and streamline compliance while pushing innovative product development approaches like QbD upstream in your pipeline, you can, quite clearly, save at least 6% of your total budget and get a far better feel for how likely your product is to get a good level of reimbursement.

So...let's see, 1.2 billion dollars x .06 equals $72 million.  That's a good bit of savings.

The NICE Challenge

Rather than complaining about where NICE is drawing the line on one specific medicine reimbursement versus another, I see NICE offering a challenge to our industry:  Can we figure out how to consistently make those extra moments of life worth the cost of our medicines?  Can we figure out new medicines that help serve everyone's interests?  Can we innovate to save lives AND save money?

I think we can.  But we can't just innovate by following the science; we're going to have to innovate across the product lifecycle, from preclinical development to postmarket monitoring.

Are you ready?

PAT and Computer Departments

As the term implies, Process Analytical Technology (PAT) relies on technology to help bring biopharmaceutical and device factories into the 21st century.  For many, this means working with your information technology (IT/ICT) department.

IT/ICT Assessment

To determine how you can work with IT/ICT, you need to establish how effectively your computer department is operating:

• Is your IT/ICT group struggling with the day-to-day and barely keeping its head above water?

          OR

• Is your IT/ICT group making good progress on bigger picture projects and strategic objectives while meeting tactical project deliverables?

Fancy methodologies abound to determine this, but a quick way to get a handle on where your IT/ICT group falls in the continuum comes by asking one question:  what is the ratio of IT/ICT staff to non-IT staff?

Ratios at 1:40 and above typically imply a IT/ICT department focused on the day-to-day, with only minor progress on large-scale projects.  As a former CIO, I’ve lived in environments stretching from a 1:12 ratio to a 1:97 ratio.  Let me assure you – good service does not come from having smaller service departments … nor do good project results.  My “quick and dirty” ratio question – while not perfect – will  give you a good idea if your IT/ICT group can play a strategic project role or will have to be relegated to a more tactical level with a greater reliance on PAT vendors.

 

Technology Tool Selection

At some point in the project, you’ll be ready for automation.  IT/ICT needs to be brought in before you’ve made any choices.

Ask your IT/ICT department the following:

What is the minimum level of network technology required for any automation to hook up to the factory network (look for terms like “CAT6e” and “Ethernet” and “100Mbps”)?

·         These items must go into any spec sheet to review potential vendor products.

How do you plan to integrate the system into the network?  Do you plan to do it yourselves or have the vendor help?

·         Rarely will an IT/ICT department choose to do it themselves, but offering the choice shows confidence and trust in your IT/ICT colleagues as valued team members.

What would you like to see in terms of long-term maintenance contracts with various vendors?

·         This is critical for long-term cost control and maintaining a qualified environment.

Are there any technology initiatives involving the factory infrastructure we (and any PAT vendors) should be aware of? 

·         After you’ve bought the automation tools and signed long-term vendor support contracts is not the time to learn about the factory network upgrade project.

 

Bring in IT/ICT Early

Make sure to ask IT/ICT to the table early on in your activities; they may need to schedule significantly in advance to best to help you.  This is especially the case if you outsource your computer department.  Depending on the terms of your contract, find out from your Purchasing group if the contract will cover this type of work in the factory, or if you’ll need to carve out a separate statement of work and quality agreement.

Based on my experiences working up the ladder from the help desk to CIO, support groups always appreciate a friendly “heads up” followed by a bit more information on what might be required.  Judge what you will say based on your estimate of what stage your IT/ICT department is in.

An IT/ICT department that is making good progress on strategic level projects plus supporting the day-to-day may want to kick-off a project.  An IT/ICT department struggling to keep its head above waters just in the day-to-day maintenance and installation may not want more than a “heads-up” and a “we’ll keep you cc’d on the meeting minutes, but for now, we’re still a long way away.”  That type of reassurance will help you gain positive reactions.

Always insist on IT/ICT being part of your project; do not let IT/ICT run a separate, parallel project.  I cannot begin to tell you the number of times I’ve seen that “separate but parallel” approach fail miserably (download the PDF of my article Six Rules for Great IT Project Success from the Journal of Projects & Profits and The Independent).

 

Final Thoughts

Process Analytical Technology relies on automation technology and in-line sampling.  This makes it necessary to work with your IT/ICT department to ensure you get the biggest bang for your buck when exploring various pieces of equipment and toolsets.

Remember, however, that PAT is not just technology; if anything, the “T” for technology is really just a third of the overall PAT framework. The bulk of PAT is analysis, risk management, science, statistics, and process management.  The “T” in PAT is only automated tools that will help you do this work faster.

 

Have a different opinion?  Post it and help everyone improve.

Featured Reading: Training for Dummies

With many quality systems management reviews including an assessment of organizational training needs, my featured reading choice is one of the best books on training I’ve found in 20 years:  Elaine Beich’s Training for Dummies .

The beauty of this book is its simplicity.  For the busy executive faced with leading an upcoming presentation or training session, the book is perfect for finding just the right amount of information to improve your game.

And for compliance executives tasked with continual improvement, the philosophy of the author should appeal:  “The purpose of training is to improve performance” (p. 260).

Three parts of the book I’ve found helpful over the years when I give corporate workshops and training:

·         How to determine if there is a good reason to conduct actual training (versus coaching, e-mailing information, presentations, etc.);

·         How to set reasonable objectives and get employees engaged; and

·         How to create effective visuals, start and end sessions on strong notes, and calm your own anxiety.

Throughout are many tips on improving effectiveness—something crucial to improving performance, compliance and competitiveness.

Skip the webinars and teleconferences on “effective training” and spend less than $15 on Training for Dummies .  You’ll soon know why everyone else can’t get good quality systems training.

Another Pharma Lesson on Having a Records Retention Policy

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 (http://www.ceruleanllc.com/seminars) 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?