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Before I pop this pill, I'd like to know where it came from

March 22, 2009|DAVID LAZARUS

Over-the-counter pain relievers such as aspirin, ibuprofen and acetaminophen are among the most commonly taken drugs in the United States. But here's a question: Where do they come from?

I ask because a rule took effect last week requiring that labels for most fresh meats, along with some fruits and vegetables, include the country of origin. The thinking is that consumers have a right to know the source of what they eat.

But why stop there? In an increasingly global economy, transparency should be the order of the day. The country of origin of all ingested products should be disclosed so consumers can make informed decisions about what they put in their bodies.

Pharmaceuticals, for instance.

I have a bottle of extra-strength, 500-mg. Sunmark pain reliever in my desk drawer that the label says is a generic equivalent of extra-strength Tylenol. In other words, it's acetaminophen. I take it because I spend far too much time staring at a computer screen.

But where does it come from? All the label says is that this is "another quality product distributed by McKesson," the San Francisco drug wholesaler. As for who actually made the little white pills, or where, no information is provided.

The Sunmark website isn't helpful. All it says is that "more than 1 billion Sunmark tablets are created each year with the same manufacturing practices and quality testing guidelines that the Food and Drug Administration sets for all medications."

A call to the customer-service line given on the website got me nowhere. "This number is for retail pharmacies only," a rep said. "I can't answer your questions."

So I placed a call to McKesson's headquarters to see if that would help. While I waited for a response, I did a little poking around on my own to see what kind of paper trail exists for Sunmark acetaminophen.

Several hours of Internet hunting later, I was still nowhere.

What I did learn, though, is that more than half of the world's aspirin now comes from China, as does more than a third of acetaminophen and almost all synthetic vitamin C. Chinese drug imports into the United States top $700 million a year.

China's thousands of drug factories also produce a wide range of raw ingredients that are shipped elsewhere for inclusion in finished drugs.

Last year, contaminated batches of the blood thinner heparin killed more than a dozen people. The active ingredient in the drug was traced to a factory in Changzhou, west of Shanghai.

A McKesson spokesman finally got back to me by e-mail. He said that "Sunmark extra-strength acetaminophen is manufactured in Allegan, Mich., by Perrigo Co."

That would be reassuring, I suppose, if it were the whole story. But it's not.

Perrigo is the world's largest manufacturer of store-brand over-the-counter medicines. Its hundreds of clients include the likes of Wal-Mart, Safeway, CVS and Walgreens.

Perrigo has facilities all over the world. The company says the active ingredients for its various products come in part from plants in Israel, Germany and China.

But apparently it also gets its supplies elsewhere. In 2006, Perrigo recalled 11 million bottles of acetaminophen sold under various brands. Small metal fragments were found in some batches.

Perrigo said in a subsequent regulatory filing that the recalled caplets contained "raw material purchased from a third-party supplier."

Arthur Shannon, a Perrigo spokesman, declined to identify the supplier or its country of origin. Nor would he comment on whether Perrigo contracts with Chinese firms for its production of acetaminophen.

"Like all global pharmaceutical companies, we source globally -- in fact, companies do not have a choice on this, since some ingredients are available in certain places only," Shannon said.

He added that Perrigo has "world-class quality systems and controls in place to assure the safety and quality of materials we use to make our products."

The Pharmaceutical Research and Manufacturers of America, an industry group, says the federal government insists on such quality controls for all pharmaceuticals sold in the U.S.

"Consumers can take comfort in knowing that a new-drug approvals process is in place, and good manufacturing practices are in place no matter where a drug is produced," said Kendra Martello, the group's assistant general counsel.

But it seems to me that if the U.S. Department of Agriculture can boost market transparency by letting people know that apples come from New Zealand or that a fish was raised on a farm and not in a babbling brook, the FDA can require similar openness when it comes to pharmaceutical products.

How about this: All prescription and over-the-counter drugs would have to state on the label where the product was manufactured -- not just, as is often the case, where the company's headquarters are.

If a product was manufactured by another company, such as Sunmark's pain reliever actually coming from Perrigo, that would have to be disclosed on the label as well.

Moreover, the label would include a Web address where more-detailed information could be obtained, including a list of the countries of origin of all active and inactive ingredients, along with contact information for the various manufacturers and suppliers.

Ultimately, this is about accountability. I'm not saying that drug makers should be required to do everything in-house. But as a consumer, I'm entitled to know exactly what I'm putting in my mouth and how it got there.

And if everything's as aboveboard as the pharmaceutical industry says, a little transparency shouldn't be a problem for anyone.

Now you'll have to excuse me. All this rummaging through the corporate underbrush has given me a headache.


David Lazarus' column runs Wednesdays and Sundays. Send your tips or feedback to

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