So That's Where My Drugs Come From
Yesterday, a company I had never heard of before recalled 11 million bottles of acetaminophen because it found pieces of metal the size of a couple grains of salt in the pills.
Nothing life threatening, mind you. But as with E. coli-tainted spinach, yesterday's recall taught me a lot about where many of the medicines and supplements I take come from.
The substance in this case is generic painkiller sold under store brands at more than a hundred retailers nationwide such as CVS, Safeway, and Wal-Mart.
The company that recalled the drug, Perrigo Co. of Allegan, Mich., makes just about every generic version of popular over-the-counter medicine and nutritional supplement you can think of: NyQuil, Sudafed, Claritin, Centrum vitamins, even Garlique.
In fact, according to Perrigo CEO Joe Papa, every man, woman and child in the U.S. takes an average of one Perrigo-made tablet every four days!
It's not hard to believe. While writing the story, I reached into my desk drawer and pulled out my stash of CVS extra-strength non-aspirin pain reliever. The bottle fell within the recalled expiration dates but it wasn't part of an implicated lot.
The funny thing is that nowhere on the bottle does it say who makes the pills, only who distributes them, so as consumers you have no way of knowing where the heck it actually comes from.
Then, there are the things drug makers do before they put them in the bottle.
Some of the lots involved in the recall are for pills sold as long as three years ago. So when did the company discover the problem? From what it said in its press release, the company told the FDA on Nov. 2. Perrigo noticed some tablet-making equipment was wearing out prematurely. Somehow, this led the company to run 70 million pills through a metal detector, of all things, which turned up the metal fragments.
Granted, you don't feel the same shock when you learn that one little-known company makes your headache medicine, decongestant and daily vitamin, as you do when you find out the chicken you had for lunch didn't come from some nice farm but an industrial feedlot operation where it didn't see the light of day and was pumped full of hormones.
But it did raise a similar issue, which is when you have centralized production combined with national distribution, a small problem can easily turn into a much larger-scale one.
It turns out that this was Perrigo's 11th recall for the year and its 23rd since 2001. A previous acetaminophen recall involved pills contaminated with bits of acrylic mirror.
How did that happen?
It falls to the Food and Drug Administration, which oversees drug-manufacturing operations, to find out.
The FDA seems to have been keeping an eye on Perrigo, inspecting them seven times over the past five years--that's more often than their usual frequency of about once every two years.
Sidney Wolfe of Public Citizen says inspections don't mean much if FDA can't fine the companies when they find violations.
It isn't cheap for drug makers to do these recalls, which cost million of dollars. Not to mention the damage done to their reputations. In the case of Perrigo, though, the retailers keep lining up to buy the company's drugs, regardless of its recall record, and the company appears to be doing well financially, with annual sales topping $1 billion.
Marc Scheineson, a former FDA official and food and drug law expert, assures me that the prospect of getting sued by personal injury lawyers is incentive enough for drug makers to be conservative about recalling their products. But if that was truly enough, would Perrigo really have had so many recalls?
Do you think the FDA needs more teeth? Or is the fear of John Edwards enough to make sure companies do the right thing?
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