Latest Drug Recalls and Bad Press for Pharma Train Spotlight on Lean Manufacturing

Latest Drug Recalls and Bad Press for Pharma Train Spotlight on Lean Manufacturing

Recent drug recalls and the inevitable bad press for the pharmaceutical industry are forcing drug makers to shift their focus to the manufacturing aspect of the drug-production process. Reigning in outsourcing and implementing lean manufacturing solutions can help pharmaceutical companies polish up their tarnished image and regain a competitive edge.

The latest rash of drug recalls has only exacerbated the consumer and media backlash against drug makers. Here are just a few examples of the most recent:

9 October 2010 Reports of an uncharacteristic odor caused Pfizer to recall the 40-mg bottles of LIPITOR. (fda.gov)

8 October 2010 FDA pressure led the manufacturer of Merida (sibutramine), Abbott Laboratories, to recall the drug in the US, Canada, and Australia owing to the possibility of cardiovascular events after long-term use. (drugrecalls.com)

7 October 2010 Owing to FDA violations with respect to its anti-aromatase ingredient, all lot codes of the testosterone enhancer Novedex XT are being recalled by Gaspari Nutrition. (fda.gov)

25 September 2010 Amgen is voluntarily recalling certain lots of EPOGEN and PROCRIT because of possible contamination by glass flakes. (usrecallnews.com)

But these recent events, coming on the heels of the massive triple recall by Johnson & Johnson, have also created a new opportunity for the pharmaceutical industry to emphasize manufacturing and to implement much needed lean manufacturing solutions.

In 2009, drug recalls (for both prescription and over-the-counter drugs) soared to an unprecedented high of 1,742 from just 426 in 2008, largely a result of outsourcing and indiscriminately cutting costs to the bone. With the current dearth of new blockbuster drugs and the cost of bringing new drugs to market in the neighborhood of $1.5 billion, drug companies are struggling. The opportunity is at hand, therefore, for them to benefit from a new image and from lean manufacturing implementation.

Lean manufacturing techniques work, but their effective implementation in the pharmaceutical industry requires knowledge of the special conditions that obtain in the industry: the difficulties involved in altering batch sizes, the fact that 75% of drug recalls can be attributed to manufacturing defects, compartmentalization of various departments within the process, and burdensome regulatory compliance concerns. And an added ingredient in the mix is pharmaceutical companies' growing use of contract manufacturing organizations (GMOs). Companies now have to manage increasingly complex external relationships while still ensuring quality.

According to Nigel Smart, Managing Partner of Smart Consulting Group, "With so much talk about outsourcing off-shore, American jobs are being lost at an alarming rate in an area where there's been traditional strength. Strategically, this is a problem for the US Pharmaceutical industry. Perhaps now's the time for us to re-assert this strength? However, we'll only be able to do that if we apply the appropriate techniques and methods in a logical and consistent fashion." Fortunately, manufacturing is the one aspect of drug production most amenable to change and improvement, where companies can rebuild their image and regain their competitive edge.

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