ProPublica wished to know one thing easy: The place a extensively used generic drug was made and whether or not that manufacturing unit had any high quality issues. As a substitute, we discovered ourselves navigating a labyrinth of firm names and sophisticated databases that few common customers would even know exist.
And even in spite of everything that detective work, we hit a useless finish.
Atorvastatin is a generic drug that treats excessive ldl cholesterol and prevents coronary heart assaults and strokes. It’s one of the crucial generally prescribed medicines in the US, and lots of producers make it.
We began with a label on a affected person’s capsule bottle. It reveals the identify of what seems to be the drug’s producer: Quallent. The one addresses on the label are in Ohio and New Jersey and are for Categorical Scripts, an organization that manages prescription advantages for insurers and employers.
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Myriam Wares for ProPublica
So we went to DailyMed, an internet database with labeling info for medication. There we discovered 21 pages of atorvastatin generics. We seemed for Quallent and located two listings for the corporate.
Each confirmed that Quallent, based mostly within the Cayman Islands, was simply the packager of the drug. So what firm manufactured it?
One label famous that Quallent sourced its tablets from a drugmaker in India, one other mentioned they got here from an organization headquartered in Canada. Nothing on the capsule bottle informed us which of the 2 made the tablets. So we seemed on the markings on our affected person’s atorvastatin tablets and in contrast them to the capsule descriptions in DailyMed. Seems the ones in our bottle were manufactured by the Canadian firm Apotex.
We had been fortunate to have the ability to discover even this a lot. The data on DailyMed included the identify of the drug’s producer. That’s usually not the case. DailyMed additionally offered a partial tackle in Toronto, dwelling to the worldwide headquarters of Apotex in addition to a number of of its crops. However the info didn’t particularly inform us if the drug is definitely made at a Toronto manufacturing unit.
To study extra, we scrolled to the underside of the DailyMed web page to seek out what’s generally known as the ANDA quantity, which is assigned when an organization applies for approval to make a drug. We took that quantity and went to a different database referred to as the Orange Book, the place all medication authorized by the Meals and Drug Administration are listed.
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Myriam Wares for ProPublica
We put in our ANDA quantity and we had been in a position to affirm that Apotex was the producer and likewise study that the corporate acquired approval to begin making atorvastatin in 2012, which might information our seek for FDA inspection experiences in regards to the manufacturing unit.
However alas the Orange Guide doesn’t inform us the place Apotex makes the drug. The corporate’s web site says it has factories in Canada, Mexico and India, nevertheless it doesn’t say which medication are made the place.
If any shopper bought this far, we’d be impressed. However right here’s the place the search bought actually difficult.
Even with our ANDA quantity and the identify Apotex, we couldn’t discover the precise manufacturing unit the place our atorvastatin was made. The FDA has that info — it’s on the purposes that firms flip in after they apply for brand new drug approvals — however the company hasn’t made these addresses obtainable to the general public.
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Myriam Wares for ProPublica
Final 12 months, we filed a Freedom of Data Act request for these places. Months handed and we finally sued the FDA in federal court docket. Lastly, the company gave us a number of the addresses, however not an entire listing.
Within the case of our atorvastatin, no luck. The company didn’t give us that manufacturing unit’s particulars, saying it held again addresses for drugmakers that employed different firms — contract producers — to make their medicines. So despite the fact that we had info that the general public doesn’t have, we had been nonetheless caught.
We went to a personal agency referred to as Redica Systems and paid to make use of a database of experiences written by FDA inspectors after visits to drug factories. We might see inspections for varied Apotex factories in Canada and India that described issues over time in the best way medication had been made. The FDA, nonetheless, blacked out the names of the medicines on these experiences.
That’s the place we hit a last useless finish. In spite of everything that, we nonetheless don’t know the place our atorvastatin was manufactured and whether or not the manufacturing unit had a troubled report.
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Myriam Wares for ProPublica
We reached out to Apotex to see if we might study extra however by no means heard again. On its web site, the corporate says, “Affected person security and regulatory compliance information each stage of our manufacturing course of.”
Although the FDA has held back factory information for decades, company officers lately requested Congress for the authority to require that producers disclose the place medication are made on the labels of capsule bottles.
Brandon Roberts of ProPublica contributed analysis.
