What Occurred When We Tried to Discover the Manufacturing facility That Made Atorvastatin — ProPublica

ProPublica needed 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 any case 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 vital generally prescribed drugs in the USA, and lots of producers make it.

We began with a label on a affected person’s capsule bottle. It reveals the title 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.

So we went to DailyMed, a web-based database with labeling data for medication. There we discovered 21 pages of atorvastatin generics. We appeared 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 drugs from a drugmaker in India, one other mentioned they got here from an organization headquartered in Canada. Nothing on the capsule bottle advised us which of the 2 made the drugs. 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 had been manufactured by the Canadian firm Apotex.

We had been fortunate to have the ability to discover even this a lot. The knowledge on DailyMed included the title of the drug’s producer. That’s usually not the case. DailyMed additionally supplied a partial tackle in Toronto, residence to the worldwide headquarters of Apotex in addition to a number of of its vegetation. However the data 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 referred to 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 E book, the place all medication accepted by the Meals and Drug Administration are listed.

We put in our ANDA quantity and we had been in a position to affirm that Apotex was the producer and in addition study that the corporate obtained approval to begin making atorvastatin in 2012, which might information our seek for FDA inspection stories concerning 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, but it surely doesn’t say which medication are made the place.

If any shopper received this far, we’d be impressed. However right here’s the place the search received actually sophisticated.

Even with our ANDA quantity and the title Apotex, we couldn’t discover the particular manufacturing unit the place our atorvastatin was made. The FDA has that data — 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.

Final yr, we filed a Freedom of Data Act request for these areas. Months handed and we finally sued the FDA in federal court docket. Lastly, the company gave us a few of the addresses, however not a whole record.

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 drugs. So regardless that we had data that the general public doesn’t have, we had been nonetheless caught.

We went to a non-public agency referred to as Redica Methods and paid to make use of a database of stories 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 way in which medication had been made. The FDA, nevertheless, blacked out the names of the drugs on these stories.

That’s the place we hit a ultimate 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 file.

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 data for many years, company officers just lately requested Congress for the authority to require that producers disclose the place medication are made on the labels of capsule bottles.