I recently read an excellent article (http://immelresources.com/HistoryofGMPs.pdf) recounting events that led up to the formation of the FDA and subsequent key laws. As an Operational Excellence (OE) person, it’s tempting to view compliance as a pain, but this reminded me of the real importance of regulatory oversight.

One of the things that can drive Operational Excellence (OE) folks crazy is the extent of inefficiency and seemingly non-value added work that occurs around maintaining compliance in a life sciences company. Tracking deviations, conducting bio-burden tests, documenting process changes and rigorously controlling documents doesn’t fundamentally change the product coming out of the bioreactors and going into patients. Instead, it is all part of the safety net and oversight that makes it harder for faulty drugs or devices to get out the door. For an OE practitioner dedicated to streamlining operations, eliminating waste, and maximizing customer value, it can be frustrating to slog through layers of red tape and quality systems to drive valuable improvements in the business. Wouldn’t our jobs be so much easier without compliance requirements? Wouldn’t drugs be cheaper?

That said, I would like to take a moment to consider where we would be without the FDA and GMP regulations. The history of the FDA reads a like a thriller with greedy villains, deceit in marketing, disregard for human life and tragic deaths that are countered by  public outrage and protection fundamental rights of each of us to safe, efficacious and truthfully labeled medicine, the rise of science in federal law and even heroes (FDA reviewer Frances Kelsey saved the US from thalidomide in 1962 http://en.wikipedia.org/wiki/Frances_Oldham_Kelsey ).

Before the FDA and the volumes of legislation we follow today, there was snake oil, diphtheria vaccines contaminated with tetanus virus, unsafe infant formula, thalidomide, cyanide-laced acetaminophen and AIDS-infected blood banks. These and many more instances of were results of intentional as well as unintentional consumer deceit, uncontrolled manufacturing, lack of clinical trials, absence of scientific methods and lack of oversight. And by the way, these horrible examples have occurred not only with drugs, but also with medical devices, cosmetics and food – all of which are now under the FDA’s jurisdiction. 

 The history of the FDA and related legislation also reads like a textbook in case law. Rather than a strategic, coordinated effort, new laws have tended to emerge after bad things happen and then get added to the pile. After a century of bad things happening, we are left with a behemoth of complex, broad-reaching and often burdensome rules that need to be followed throughout the industry. 

From this I’ve drawn out two implications for Operational Excellence:
1. There is a great opportunity to apply OE methodologies to improving the performance of compliance activities such that they don’t bog down the core, value-adding (e.g. manufacturing) activities of the business.
2. Companies that strive for excellence tend to view compliance as the minimum threshold for performance. So not only OE can co-exist with compliance but it can even make compliance easy!

So, next time you’re on an OE project, or any project for that matter, where QA, RA or GMP rules are getting in your way…step back a moment and consider where we’d be without the FDA regulations…

For more about the fascinating history of the FDA, check out these sources:
• FDA page on the “American Chamber of Horrors”: http://www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/ucm132791.htm#ref44
• Excellent article telling the story of the FDA: http://immelresources.com/HistoryofGMPs.pdf
• The fascinating story of Thalidimide, Dark Remedy: http://www.amazon.com/Dark-Remedy-Thalidomide-Revival-Medicine/dp/0738205907

Jason Dunklee

Tags: Operational Excellence

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