One of PharmTech’s columnists recently wrote about individuals working in quality assurance and how, after becoming more sensitized to a problem, they significantly increased their performance. Specifically, the employees were in charge of identifying spots on finished vials—if they found a spot of a certain size, they rejected the vial. When one employee starting finding more spots than usual and bragged to his colleagues, they all started finding more spots until the team was rejecting 20% of the finished vials. Ultimately, the company tweaked its specs for rejects—not all spots were worthy of rejecting the vial—and the percentage of rejects fell back into normal operating range. It’s unclear whether the quality assurance team noticed more spots to remain competitive with their colleagues (“I found 25 spots today, how many did you find?”), or because they hadn’t been performing their jobs as well as they could have beforehand, or because production was in fact becoming more defective. (You can read the full column by Lynn D. Torbeck in our September 2010 issue.)

This quality assurance story seems to relate to the plethora of food and drug recalls occurring in the United States recently. Since April alone, we’ve seen brand-name, over-the-counter cold and allergy medications for children and adults taken off the shelves, as well as certain brands of cereal, frozen fruit products, hand sanitizers, alfalfa sprouts, romaine lettuce, and medical devices. And this past week, consumers, grocers, and restaurateurs have faced a massive shell-egg recall. (The egg recall in particular is quite ironic given that FDA issued a guidance on April 13 of this year for small egg producers to help them comply with a 2009 federal egg-safety regulation designed to prevent Salmonella Enteritidis in shell eggs during production, transportation, and storage.)

However, the seemingly constant flow of recalls begs the question—what in the world is going on? Why are so many recalls occurring? Clearly, it’s never been this bad. Or has it?

It turns out that FDA publishes on its website an archive of recalls, market withdrawals, and safety alerts going back to 2004. A quick review of all the recalls, withdrawals, and alerts issued in December of each year shows the following: in 2009, FDA issued 28 recalls, withdrawals, and alerts; in 2008, there were 16; in 2007, there were 22; in 2006, there were 10; in 2005, there were 13; and in 2004, there were 21. Based on this quick (nonstatistical) review, it would appear that the number of recalls over a five-year period isn’t changing too significantly. Although 2009 had the highest of the archived recalls, withdrawals, and alerts (28), there were 21 such instances in the year 2004.

It’s possible that FDA (and industry) is becoming more vigilant in identifying contaminated and faulty products. It’s also possible that because of one recall, another company may be looking more closely at its own goods and finding problems. Or, it may be that just as cold and flu seasons are sometimes worse one year compared with another year, and just as the financial market ebbs and flows, so too do manufacturing and quality deviations. And unfortunately, no one can accurately predict any of these changes, even when they negatively affect consumers, patients, and bank accounts.