Every bottle of prescription medication carries an implicit promise that the drug is safe, effective, and meets rigorous standards set by the Food and Drug Administration.
But the agency, known as one of the world’s toughest regulators, has only intermittent oversight of overseas factories where generic drugs are manufactured. And if researchers find mold, unclean equipment, or contaminants in those facilities, the FDA will keep secret the names of the drugs they make.
In many cases, consumers have no way of knowing whether the medicine they are taking was manufactured in a factory that uses dirty water, is infested with insects or birds, or is in any case granted special exemptions despite a total ban on shipping medicines to the United States.
Today, ProPublica launched Rx Inspector. This is the first database of its kind to provide answers to things the FDA won’t tell you: where generic drugs come from and the track record of the factories that make them. Finding information is harder than you think.
Vial labels often list the distributor or repackager rather than the actual manufacturer, and sometimes have no information at all. When ProPublica asked readers to send in photos of pill bottles, our inboxes were flooded with photos that prove how difficult that information is to obtain.
Although 90% of prescriptions filled in the United States are generic drugs, the FDA provides only fragmentary information about generic drugs. Information is scattered across a variety of websites, and there is no easy way to link drugs to manufacturers, factory locations, and regulatory history. Our journalists spent months piecing together that data. In one case, ProPublica had to sue the FDA in federal court and received a partial list of factory locations.
This app allows you to connect your drug to the manufacturer, the manufacturer’s specific plant, FDA inspection reports, and any significant compliance violations associated with that facility obtained by ProPublica.
For example, you can enter the name of the drug and information about the company that manufactured the drug on the label of the pill bottle. If you don’t have a company name, you can enter details that lead to specific drug information, such as pill color or markings on the pill. From there, you can find out the name of the actual manufacturer (not just the company that repackaged or distributed it). You can also see the address of the factory that manufactured it.
If your factory has been inspected by the FDA, we will provide you with the inspection report and subsequent warning letter. Not all inspection reports are accessible, so you may only see summary information, including inspection dates and results.
We’ve added advanced search options for pharmacists and those who are particularly knowledgeable about pharmaceuticals. This allows you to enter important information such as national drug laws and get manufacturing and regulatory details instantly.
Finally, the app allows you to learn more about individual pharmaceutical companies as a whole by providing a way to search for factories. Enter a company name to see when their factory was last inspected and whether the FDA has taken any action in recent years.
Keep in mind that if you find a questionable test report, it doesn’t necessarily mean your medicine is at risk. Your doctor or pharmacist will advise you not to stop taking your medicine. Instead, you should discuss your concerns with your health care provider.
ProPublica briefed the FDA on the app and the methods used to build it, but the FDA did not comment. The agency previously told ProPublica that inspection reports do not reveal where the drugs are manufactured to protect what it considers commercially sensitive information.
Our data is incomplete in places. For example, the FDA does not publish all inspection reports. And while the agency provided ProPublica with a list of drugs and the factories that make them, some locations were missing. We will add more details as they become available.
But this app provides the most detailed information yet about America’s generic drug manufacturers and whether they meet manufacturing standards to keep us safe.
