To understand how dangerous drugs can end up on medicine shelves, ProPublica spent more than a year and a half investigating the Food and Drug Administration’s oversight of overseas factories that produce generic drugs and have been cited for violating important quality standards.
Through our reporting, it quickly became clear that patients and doctors were not ensuring they had the information they needed to make informed decisions about the drugs they took or prescribed.
ProPublica has created a tool aimed at helping you with this: Rx Inspector.
Search for generic prescription drugs and direct you to the specific facility where they were manufactured. We were able to link more than 80% of the generic prescription drug products in our database to the factories that manufactured them using a database of label information, manufacturing facilities, and location data that led to FDA litigation. We also included a history of FDA actions at these facilities based on the large amount of inspection records we collected.
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.
Find your prescription using this tool.
Our ongoing reporting has focused on the safety of generic drugs, which account for the majority of all prescriptions filled in the United States. So, at least for now, Rx Inspector does not include branded or over-the-counter drugs. Gases (such as oxygen tanks) and intradermal route drugs (many of these were allergy tests for things like cat hair) were excluded.
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.
Here’s how:
Get a list of medicines and facilities
First, I needed to get a list of prescription medications. I downloaded the National Drug Code product list from the FDA. Companies wishing to manufacture generic drugs must submit an Abbreviated New Drug Application to obtain approval. We used these ANDA numbers to filter the list to generic drugs only.
We also included biologics such as insulin. We chose to include authorized generics, which are branded drugs sold without a brand name label, because we believed that consumers may not know that their “generics” are actually branded drugs.
They then added the drug list to DailyMed’s Structured Product Labeling database. This database is a National Institutes of Health resource that contains information on more than 155,000 drug labels submitted by companies to the FDA. We used that data to obtain basic information about the drug, such as its shape (tablet, injection, etc.), dose, color, and stamping. In some, but not all cases, it also included an identifier or address that could be used to link to the agency’s official list of manufacturing locations.
The drugs were then matched against three different facility lists.
The first major list is obtained from the FDA’s Electronic Drug Registration and Listing System. Its database contains addresses of pharmaceutical companies’ factories. There are also two numerical identifiers: the FDA establishment identifier and the Dun & Bradstreet (DUNS) number.
The second facility list comes from a federal lawsuit filed against the FDA seeking a list of manufacturer addresses associated with ANDA numbers. I received a partial list. I used it when I only had the ANDA number for the drug.
And finally, we got a list of historic establishments. This allows you to identify production sites and link to them via FEI number if other routes do not work.
combine them
In October, we detailed a failed search to find the original manufacturer of a popular cholesterol generic, with a maze of company names and a complex database that most consumers likely didn’t even know existed. We determined that we needed to do something similar for approximately 47,000 medicines.
Different datasets had different identifiers, and finding the correct facility required linking multiple datasets. For example, if all we had was an ANDA number, we used the facility list we obtained in the lawsuit, which was also listed by ANDA. If you have an FEI, you could link it to the FDA’s official facility list.
In some cases, they had neither. In the absence of a useful identifier, we searched product label data for manufacturing addresses and attempted to match them to facility lists. We used both fuzzy text matching and geocoding to do this, and manually checked the matches.
For repackaged or relabeled drugs, the source NDC code was used to trace them back to the original label.
In total, we were able to fit over 39,250 products into our manufacturing facility.
Acquisition of inspection data
Connecting individual drugs is only half the battle. The next thing we did was get the FDA inspection results for our facility and add it to our facility list.
We obtained data regarding FDA testing from a variety of sources. First, since 2008, we have used the FDA’s public inspection dashboard for inspections. We only used information related to pharmaceuticals or biologics, excluding tests related to food, cosmetics, tobacco, medical devices, and veterinary drugs. The dashboard included inspection dates and results, as well as citations detailing violations of federal regulations. We linked these reports to facilities with matching FEI numbers.
Even so, only limited information was available for testing. For more detailed documentation, a so-called Form 483 was required, which documents the problems the inspector observed at the facility. Unfortunately, the FDA does not publish all 483s. We started by exporting what is published on the inspection dashboard, but we know this is incomplete.
We also went directly to the FDA and requested all the 483s that were already published. They delivered about 40,000 documents.
We linked the 483 to the inspection by using optical character recognition to extract text from the document, connecting the document to the facility using the FEI number, and discovering inspections for that facility within 10 days of the date of the letter. It was not possible to link all 483 to a test because the FDA’s public test data does not include all tests performed by the FDA.
The FDA has issued a warning letter detailing “serious violations of federal requirements.” We retrieved these from the FDA website back in 2020, filtered out those not related to drugs, and connected the rest to facilities using FEI numbers.
As ProPublica detailed in a report earlier this year, some facilities have been banned entirely from transporting drugs to the U.S. market for some time, with exceptions for certain drugs. The FDA calls this an import alert.
We used the Internet Archive’s Wayback Machine to search hundreds of import warning lists issued by the FDA over 15 years. The list identified factories that were prohibited from shipping drugs to the United States because the FDA found manufacturing violations.
We focused on 66-40 alerts that alert drug manufacturing facilities that do not meet “Good Manufacturing Practice” standards. We considered the publication date of the alert as the start date. Because we cannot know when the alert was lifted, we use the last date the property appeared on the list to estimate the approximate value. Import alerts do not include FEI numbers to easily identify the facility in question, so we linked them to the facility using facility name and address.
We attempted to identify exceptions for importing alerts by searching for strings such as “Exempted from DWPE” (“Detention without Physical Search”) and manually parsing them to obtain a clean list of drugs.
To assist with our research, we paid access to Redica Systems, a high-quality regulatory intelligence firm with a vast collection of FDA inspection documents. We used Redica’s database to spot-check our work.
We know that much of the data presented here is likely an undercount. Clerical errors can result in lost connectivity. FDA may remove test results from your dashboard. Additionally, our methods of scraping through the Internet Archive are subject to availability. There were also limitations on how to obtain complete 483s, warning letters, and import warnings. There may be additional communications between the company and the FDA, but these are not publicly available and therefore are not reflected in the database.
Still, this is the most comprehensive public list of FDA actions related to drugs ever created.
