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 complicated databases that few common shoppers would even know exist.
And even in any case that detective work, we hit a lifeless finish.
Atorvastatin is a generic drug that treats excessive ldl cholesterol and prevents coronary heart assaults and strokes. It’s one of the generally prescribed medicines in america, and lots of producers make it.
We began with a label on a affected person’s capsule bottle. It exhibits 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, a web-based database with labeling info for medicine. There we discovered 21 pages of atorvastatin generics. We appeared for Quallent and located two listings for the corporate.
Each confirmed that Quallent, primarily based within the Cayman Islands, was simply the packager of the drug. So what firm manufactured it?
One label famous that Quallent sourced its capsules from a drugmaker in India, one other mentioned they got here from an organization headquartered in Canada. Nothing on the capsule bottle instructed us which of the 2 made the capsules. So we appeared on the markings on our affected person’s atorvastatin tablets and in contrast them to the capsule descriptions in DailyMed. Seems those in our bottle have been manufactured by the Canadian firm Apotex.
We have been fortunate to have the ability to discover even this a lot. The knowledge on DailyMed included the identify of the drug’s producer. That’s typically not the case. DailyMed additionally supplied 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 search out what’s often called 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 E book, the place all medicine permitted by the Meals and Drug Administration are listed.
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Myriam Wares for ProPublica
We put in our ANDA quantity and we have been in a position to affirm that Apotex was the producer and in addition study that the corporate obtained approval to start out making atorvastatin in 2012, which might information our seek for FDA inspection studies in regards to the manufacturing unit.
However alas the Orange E book 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 medicine 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 particular manufacturing unit the place our atorvastatin was made. The FDA has that info — it’s on the purposes that corporations flip in once they apply for brand new drug approvals — however the company hasn’t made these addresses accessible to the general public.
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Myriam Wares for ProPublica
Final yr, we filed a Freedom of Info Act request for these places. Months handed and we ultimately sued the FDA in federal court docket. Lastly, the company gave us a few of the addresses, however not a whole 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 corporations — contract producers — to make their medicines. So regardless that we had info that the general public doesn’t have, we have been nonetheless caught.
We went to a non-public agency referred to as Redica Programs and paid to make use of a database of studies written by FDA inspectors after visits to drug factories. We might see inspections for varied Apotex factories in Canada and India that described issues through the years in the way in which medicine have been made. The FDA, nonetheless, blacked out the names of the medicines on these studies.
That’s the place we hit a last lifeless 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 file.
Credit score:
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 again manufacturing unit info for many years, company officers just lately requested Congress for the authority to require that producers disclose the place medicine are made on the labels of capsule bottles.
Brandon Roberts of ProPublica contributed analysis.
