The calls came in over the course of a single month in 2004, with patient after patient presenting strikingly similar complaints. Some told Oregon psychiatrist James Hancey that their new generic depression medication had stopped working. Others described unexpected reactions – dizziness, flu-like symptoms and sensations of electric shock in the brain.
“It started to say to me, ‘This medicine is no good,’” Hancey said. “You get all these phone calls where people are saying the exact same thing. »
Hancey suspected that the generic was ineffective and that his patients were suffering from abrupt withdrawal. But he had no easy way to confirm exactly where the pills came from or the safety record of the factory that made them. He began keeping what he called a “no-fly” list — dozens of generic drugs that he suspected were dangerous or ineffective — based largely on trends he observed in his patients.
Now he has something else.
Last month, ProPublica launched Rx Inspectora free, searchable tool that allows doctors, researchers and patients to trace a specific generic drug back to its manufacturer and view factory inspection history.
The researchers said they were using the tool to boost work to make the country’s drug supply safer. Health care workers said they check factory records before writing prescriptions. And patients say it’s helped them understand what might have gone wrong when a drug caused unexplained health problems or didn’t work at all.
“It’s a boon for researchers looking to study pharmaceutical manufacturing,” said John Gray, a professor at Ohio State University working on a project funded by the U.S. Department of Defense to evaluate the safety and quality of generic drugs.
Even though the Food and Drug Administration knows where generic drugs are made and inspects factories around the world, it has never allowed the public to easily see which manufacturer produced which pill or if the factory had a history of safety and quality violations.
Rx Inspector changes that. Drawing on records obtained by ProPublica from the FDA, in part by sue the agency in federal court, the tool links nearly 40,000 drugs to their original manufacturers as well as inspection reports and regulatory actions that were previously difficult, if not impossible, for the public to locate. Friday, ProPublica published some of the underlying data on GitHub, so that other journalists and researchers can build on our work.
The tool is part of a ProPublica investigation lasting several months on the FDA’s failures to oversee the generic drug industry, particularly foreign factories repeatedly criticized for drug contamination and other quality defects.
This is already reshaping the way people make decisions.
Gray and his team are working to give generic drugs a quality rating based on risk. The goal is to help government purchasers, including the Centers for Medicare & Medicaid Services, purchase drugs based on quality, not just cost. Rx Inspector has allowed his team to move faster: Researchers can easily look up factory locations and inspection details, he said.
Col. Vic Suarez, a retired Army medical supply chain commander who is collaborating on the project, said he is also using the tool for research aimed at helping new U.S.-based pharmaceutical companies produce high-quality drugs.
Healthcare workers said the tool is changing the way they counsel patients.
Hancey, the Oregon psychiatrist, said he recently shared Rx Inspector with his hospital’s training director so residents could use it to investigate generic drugs and develop their own no-fly lists. It will also refine its own list, now that it can more easily track the drugmakers behind the generics that concern it most.
“Experience has taught me that not all generics are the same,” he said. “And you don’t know who you’re dealing with. It will cut down on a lot of legwork.”
In the United States, 90% of prescriptions are for generic drugs, many of which are manufactured overseas. For years, pharmacists and lawmakers have lobbied the FDA to require manufacturers to identify themselves on pill bottle labels so that consumers and health care workers can learn more about the drugs they use and prescribe.
The FDA resisted. The former head of drug safety at the agency told ProPublica that regulators did not want to monitor thousands of companies to ensure they were providing accurate information.
The FDA requires companies to disclose manufacturing locations when applying to sell a generic drug. But it does not publish this information on its website. And while the agency posts some inspection reports online, it routinely removes the names of implicated generic drugs, even when inspectors find serious safety and quality violations.
Rx Inspector brings these threads together. Since launching the tool, ProPublica has heard from dozens of readers using it to research their own medications. They described feeling empowered, even vindicated, after learning where their drugs were made and, in some cases, discovering the FDA’s long-standing concerns about substandard manufacturing.
In Atlanta, John Beeler, 49, said he developed headaches and rashes on his sides, upper body and hands after he started taking bupropion, the generic Wellbutrin brand and one of the most widely used antidepressants in the United States.
For two grueling weeks in 2024, Beeler said he worried: Were his pills making him sick?
The FDA has received thousands of complaints about some generic versions of the drug, government records show. Tests carried out by independent laboratories — including a test commissioned by ProPublica – have exposed irregularities in the way pills dissolve in the body, which can flood patients with too much medication or leave their symptoms untreated.
Beeler, father of three children,. asked her doctor to put her on another medication. The rash and headaches disappeared almost immediately.
When Beeler then used Rx Inspector, which he found on Reddit, he learned that the pills he was taking were made in a factory in India that was repeatedly cited by FDA inspectors for shoddy manufacturing, including shipping potentially contaminated drugs to the United States.
Drug safety experts caution that the same manufacturer may produce both good and bad batches, and that patients may react differently to the same drug for reasons unrelated to manufacturing. Doctors and pharmacists advise worried patients to talk to their health care providers and not stop taking their medications on their own.
Beeler said he had no idea what caused the reaction to his generic bupropion, but having access to information about the factory and its problems with the FDA would have allowed him to make different choices.
“When someone says, ‘There are big differences in the way some drugs are made,’ it’s kind of like I’m not that crazy,” he said. “That would have answered a lot of questions right from the start.”
In Chicago, Kate Wagner, 32, took a new generic for attention deficit hyperactivity disorder last year and said she spent two weeks in a stupor, barely able to move. The experience was so disorienting that she stopped taking stimulants altogether even though she had been taking them since she was a child.
Wagner recently discovered Rx Inspector on
“I really felt in my heart that it was just a bad drug,” Wagner said. who writes about architecture. “There is a difference between an expected side effect and being made sick by a medication.”
Dawn Levitt can’t take any risks: she relies on a generic drug to protect her fragile heart. She has had two heart transplants since 2006 and takes everolimus, the generic version of the immunosuppressant Zortress, to prevent rejection.
When Levitt used Rx Inspector to research her generic, she learned that it was made in an Indian factory criticized by the FDA for quality and safety defects, including dirty drug-making equipment and destruction of records related to drug quality.
“I felt sick and anxious when I saw the violations,” said Levitt, who lives in Michigan and blogs about his medical journey. She said she quickly made plans to speak with her doctor and transplant team.
“I already had to have a second heart transplant,” she said. “This could jeopardize the survival of my heart transplant and my life.”
For Johanna Staples, the costs of poor quality medicines are already high.
Nineteen years ago, Staples lost her husband, Dennis, in one of the deadliest drug violations in U.S. history. Before receiving dialysis for complications related to type 2 diabetes, Dennis received a dose of heparin, a generic blood thinner used by m illion Americans. Moments later, he collapsed in his chair and never regained consciousness.
Investigators later determined that some generic heparins contained a contaminated ingredient from China that could cause serious allergic reactions. Dozens of deaths and hundreds of serious injuries have been reported among patients.
“I loved my husband with all my heart and miss him dearly every minute of every day with a pain that cannot be eased or healed,” Staples told a House subcommittee investigating the crisis in 2008.
Now 73, Staples takes a few generic medications herself. When she recently used Rx Inspector to look for them, she said she was amazed.
Its blood pressure medications were made in China. Last year, FDA inspectors found so many quality violations at the plant that the agency issued a warning letter, a significant enforcement action, and required improvements.
Staples said it was painful to learn that, nearly two decades after her husband’s death, patients and doctors are still often kept in the dark.
“I find it so wrong and alarming that we are not fully informed about the medications we are prescribed,” she said. “Nothing has changed.”
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