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ProPublica wanted to know something as simple as where widely used generic drugs are made and whether the factories have quality issues. Instead, we found ourselves navigating a maze of company names and complex databases that most ordinary consumers don’t even know exist.
And despite all this investigative work, we were stuck.
Atorvastatin is a generic drug that treats high cholesterol and prevents heart attacks and strokes. It is one of the most commonly prescribed drugs in the United States and is manufactured by many manufacturers.
We started by labeling patients’ medication bottles. The name of the company that appears to be the drug’s manufacturer, “Qualent,” is displayed there. The address listed on the label is only in Ohio and New Jersey and belongs to Express Scripts, a company that manages prescription benefits for insurance companies and employers.
Credit: Myriam Wares for ProPublica
So we turned to DailyMed, an online database containing drug label information. There, they found 21 pages of generic atorvastatin. We searched for Quallent and found two publicly traded companies.
Both investigations showed that Quarrent, based in the Cayman Islands, was nothing more than a drug packager. So what company manufactured it?
One label noted that Qualint sources its pills from an Indian pharmaceutical company, while another said they were sourced from a company headquartered in Canada. There was no information on the vial about who had manufactured the pills. So we looked at the markings on patients’ atorvastatin tablets and compared them to the DailyMed pill description. It turns out that what’s in our bottle is manufactured by the Canadian company Apotex.
I was lucky to be able to find this. DailyMed’s information included the name of the drug’s manufacturer. Often this is not the case. DailyMed also provided some of Apotex’s addresses in Toronto, where its global headquarters and several of its factories are located. But this information did not specifically tell us whether the drug was actually manufactured at the Toronto factory.
To learn more, I scrolled to the bottom of the DailyMed page and found something called an ANDA number. This number is assigned when a company applies for approval to manufacture a drug. We took that number and went to another database called the Orange Book, which lists all drugs approved by the Food and Drug Administration.
Credit: Myriam Wares for ProPublica
When I entered the ANDA number, I was able to confirm that Apotex was the manufacturer and that the company received approval to begin manufacturing atorvastatin in 2012. This will help you find the FDA inspection report for this factory.
Unfortunately, however, the Orange Book does not list where Apotex manufactures its drug. The company’s website says it has factories in Canada, Mexico and India, but does not say which drugs are made where.
If consumers can get this far, we’ll be impressed. But here the search became very complicated.
Even with the ANDA number and the name Apotex, we were unable to locate the specific factory where atorvastatin was manufactured. The FDA has that information — it’s on the application that companies submit when they apply for approval of a new drug — but the FDA doesn’t share its address with the public.
Credit: Myriam Wares for ProPublica
Last year, we filed a Freedom of Information Act request for these locations. After many months, we finally sued the FDA in federal court. Finally, the agency provided me with some addresses, but not a complete list.
Our case with atorvastatin didn’t work. The agency said it had withheld the addresses of pharmaceutical companies that rely on other companies (contract manufacturers) to manufacture drugs, but did not provide details of the factories. So even though we had information that the average person didn’t have, we were still stuck.
We went to a private company called Redica Systems and paid for a database of reports that FDA inspectors wrote after visiting drug factories. Inspections of various Apotex factories in Canada and India reported long-standing problems in the way the drug was manufactured. However, the FDA blacked out the names of the drugs in those reports.
So we hit a final dead end. After all this, we still don’t know where our atorvastatin was manufactured or if there was a problem with that factory.
Credit: Myriam Wares for ProPublica
We reached out to Apotex to see if they could provide more information, but did not receive a response. “Patient safety and regulatory compliance guide every step of our manufacturing process,” the company says on its website.
After decades of concealing factory information, FDA officials recently asked Congress for authority to require manufacturers to disclose where drugs are made on pill labels.
ProPublica’s Brandon Roberts contributed to the research.
