Quality Issues Redux

As we get ready to begin the New Year, let's hope some quality resolutions are made.
Dec 02, 2010


Michelle Hoffman
A few weeks ago, I got a phone call from a producer at "60 Minutes" looking for sources for a story they were working on about quality breaches in the pharmaceutical industry. "Was there a particular breach they were interested in," I asked? When they indicated there was, I started to reel off a list of five or so recent such breaches, when I stopped myself and remarked, "There's enough here to fill a Jeopardy! category. I'll take 'Pharmaceutical Quality Breaches' for $600, Alex."

But it's really not funny, is it? For the past several years, the pharmaceutical industry has had to combat the public perception in decline. The public is unhappy with the cost of drugs, unhappy that novel drugs for unmet needs are slow to come to market, and now unhappy about a seemingly unending stream of quality breaches. Outsized prices might be forgiven if it means the public has access to high quality and highly effective medicine. The lack of innovation is somewhat more troubling for the health of the industry and the US economy and probably can't be solved by industry alone. Rather true innovation probably requires the concerted efforts of industry, academia, and the government.

Which leaves us once again with the quality question. And here, the industry is at once solely responsible for the problem and singularly capable of finding a solution. For the past few months, I've been writing about possible causes of quality breaches, starting with lack of qualified quality personnel. Until now, though, evidence for that has been largely anecdotal. But this month, Pharmaceutical Technology publishes the results of its annual employment survey, the responses to which also provide some hard data to support the allegation that quality professionals have been preferentially downsized as a result of the economic downturn.

Among those who say they've lost their jobs because of economic hard times, the largest percentage—22%—are in quality control and assurance (followed by nearly 10% each in production management, engineering and engineering management, and consulting). Another 21% who say they have kept their positions while colleagues in their divisions have not are in quality control and assurance, again the highest percentage of respondents. And among those who said their job function was eliminated, a full 40% were in quality control and assurance. So it appears that when the going gets tough, pharmaceutical companies let their quality professionals get going ... with the expected consequences.

In a time when it's harder to produce and market novel compounds, one would think the industry would take greater care with the compounds it already has on the market. They say it's easier to ask forgiveness than permission, and yet I wonder how much more forgiving the public will be, and how many more times the industry will ask. I keep hoping the industry becomes chastened by the recent spate of quality issues. Perhaps in the New Year, industry will rededicate itself to regaining the trust of the public by doing what consumers hope of it: producing highly effective, high-quality medicines.

And as long as we're discussing quality control, our publication maintains its own through the good graces and generous time and advice of our editorial advisory board and our peer reviewers, who make sure that everything we publish is of the highest quality. On behalf of the editors, we thank you for making Pharmaceutical Technology the trusted information source it is and for pushing us, the editors, to do our best. The editors would also like to thank the dozens of expert columnists and contributors who share their considerable and considered insights with us and with you. We have all benefited tremendously by your experience and your willingness to educate us. And the editors thank you, our readers, for continuing to engage us through your emails, for your responses to our (very long and detailed) surveys, for submitting your research papers to us, and for your general support, encouragement, and enthusiasm for our efforts.

We wish you all happy holidays and the very best wishes for a productive and high-quality New Year.

Michelle Hoffman is editorial director of Pharmaceutical Technology. Send your thoughts and story ideas to

Reader Comment:

I take exception to your statement "...true innovation probably requires the concerted efforts of industry, academia and the government." Hasn't the government totally mismanaged almost everything it puts its' hands on? We do NOT need government intervention for innovation. They will try to find a way to tax it out of existence. The answer is - let the people with common sense who are close to the processes figure it out. Get too many academians involved and the result is analysis paralysis.

Upper management has clearly NOT gotten the Quality message if downsizing so many quality professionals. Maybe the problem is the messengers are not conveying the right message that a quality driven company costs less than one that is not. Read any issue of Quality Progress, the journal of the American Society for Quality for tips on getting the message up. If management "doesn't get it", it's time for them to go.

Regards, M.MacMurray, Senior Member, ASQ, Dec. 23, 2010