With every bottle of prescription medication comes an implied promise: The drugs are safe and effective and meet strict standards set by the Food and Drug Administration.
But the agency known as one of the world’s toughest regulators provides only intermittent oversight of the foreign factories where generic drugs are made. And when investigators turn up mold, filthy equipment and contaminants in those facilities, the FDA keeps the names of the drugs they make secret.
Consumers often have no way of knowing if the medications they are taking came from factories that used dirty water, were infested by insects or birds, or were outright banned from shipping drugs to the U.S., but then granted special exemptions to do so anyway.
Today, ProPublica is launching Rx Inspector, a first-of-its-kind database that provides answers to what the FDA won’t tell us: where our generics are coming from and the track records of the factories that made them. The information is harder to find than you may think.
Labels on pill bottles often list a distributor or repackager rather than the actual manufacturer — and some have no information at all. When ProPublica asked our readers to send in photos of their pill bottles, they flooded our inbox with pictures proving just how difficult that information is to come by.
Even though generic drugs make up 90% of prescriptions dispensed in the U.S., the FDA only provides piecemeal information about them. It’s scattered across different websites with no easy way to link drugs to their manufacturers, factory locations and regulatory track records. Over many months, our journalists connected that data. In one case, ProPublica had to sue the FDA in federal court and received a partial list of factory locations.
You can use this app to connect your own medication to the manufacturer that made it, to the specific factory where it was made and to any FDA inspection reports and serious compliance violations linked to that facility that ProPublica has obtained.
For example, you can enter your drug name and any information on the label of your pill bottle about the company that may have made it. If you don’t have a company name, you can enter the color of your pills, or any markings on them, details that can lead you to information for your specific drug. From there, you can learn the name of the actual manufacturer (not the company that simply repackaged or distributed it). And you can also see the address for the factory that produced it.
If the factory has been inspected by the FDA, we’ll show you the inspection reports and any subsequent warning letters. We didn’t have access to every inspection report, so you may only see summary information that includes the dates of the inspections and any findings.
For pharmacists and others particularly knowledgeable about drugs, we’ve added an advanced search option so that you can enter key information, such as the National Drug Code, and quickly pull up manufacturing and regulatory details.
Finally, this app will allow you to learn more about individual drugmakers overall by providing a way to search for their factories. By entering a company name, you can see when those factories were last inspected and whether the FDA took any action in recent years.
Keep in mind that if you turn up a troubling inspection report, it doesn’t necessarily mean that your drug is compromised. Doctors and pharmacists advise that you not stop taking your medications. Instead, you should talk to your health care provider about any concerns.
ProPublica described the app and the methodology used to build it to the FDA, which did not comment. The agency previously told ProPublica that it doesn’t reveal where drugs are made on inspection reports to protect what it deemed confidential commercial information.
Our data is incomplete in places. The FDA, for example, hasn’t released all of its inspection reports. And though the agency provided ProPublica with a list of medications and the factories that made them, some locations were missing. We’ll add more details as they become available.
But this app provides the most detailed look yet at the makers of America’s generic drugs and whether they’ve met manufacturing standards meant to keep us safe.
