The calls came over the span of a single month in 2004, patient after patient with strikingly similar complaints. Some told Oregon psychiatrist James Hancey that their new generic medication for depression had stopped working. Others described unexpected reactions — dizziness, flu-like symptoms and electric shock sensations in the brain.
“That started to tell me, ‘This drug 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 he suspected were unsafe or ineffective — based largely on patterns he observed in his patients.
Now, he has something else.
Last month, ProPublica launched Rx Inspector, a free, searchable tool that allows doctors, researchers and patients to trace a specific generic medication back to its manufacturer and to see the inspection history of the factory.
Researchers said they are using the tool to turbocharge work to make the country’s drug supply safer. Health care workers said they are checking factory records before writing prescriptions. And patients say it has helped them understand what may have gone wrong when a medication caused unexplained health problems or didn’t work at all.
“This is a godsend to 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 assess the safety and quality of generic drugs.
Although 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 whether the factory had a history of safety and quality violations.
Rx Inspector changes that. Drawing on records ProPublica obtained from the FDA, in part by suing the agency in federal court, the tool links nearly 40,000 medications to their original manufacturers and to inspection reports and regulatory actions that were previously difficult, if not impossible, for the public to locate. On Friday, ProPublica published some of the underlying data to GitHub, so that other journalists and researchers can build on our work.
The tool is part of a monthslong ProPublica investigation into failures by the FDA to oversee the generic drug industry, particularly foreign factories repeatedly faulted for drug contamination and other quality failures.
It is already reshaping how people make decisions.
Gray and his team are working to assign generic drugs a quality score based on risk. The goal is to help government purchasers, including the Centers for Medicare & Medicaid Services, buy medications based on quality, not just cost. Rx Inspector has enabled 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 drug companies produce high-quality medication.
Health care workers said the tool is changing how they counsel patients.
Hancey, the Oregon psychiatrist, said he recently shared Rx Inspector with the training director at his hospital so that residents could use it to investigate generic drugs and develop their own “no fly” lists. He will refine his own list as well, now that he can more easily track the drugmakers behind the generics that concern him most.
“Experience has taught me that not all generics are the same,” he said. “And you don’t know who you are dealing with. This will cut down on a lot of the legwork.”
Ninety percent of the prescriptions in the United States are for generics, many of them made overseas. For years, pharmacists and lawmakers have pressed the FDA to require manufacturers to identify themselves on the labels of pill bottles so that consumers and health care workers could 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 didn’t want to police thousands of companies to ensure they were providing accurate information.
The FDA does require companies to disclose manufacturing locations when they apply to sell a generic drug. But it does not publish that information on its website. And while the agency posts some inspection reports online, it routinely redacts the names of generic drugs involved, even when inspectors find serious safety and quality violations.
Rx Inspector pulls those threads together. Since the tool’s launch, ProPublica has heard from dozens of readers who used it to look up their own medications. They described feeling empowered, even vindicated, after learning where their drugs were made and, in some cases, discovering long-standing concerns by the FDA about substandard manufacturing.
In Atlanta, 49-year-old John Beeler said he developed headaches and rashes on his sides, upper body and hands after he started taking bupropion, the generic for the brand-name Wellbutrin and among the most widely used antidepressants in the United States.
For two exhausting weeks in 2024, Beeler said, he worried: Were his pills making him sick?
The FDA has fielded thousands of complaints about some generic versions of the drug, government records show. Testing by independent labs — including a test commissioned by ProPublica — have turned up irregularities in the way the pills dissolve in the body, which can flood patients with too much medication or leave their symptoms untreated.
Beeler, a father of three,. asked his doctor to switch him to a different medication. The rashes and headaches cleared up almost immediately.
When Beeler later used Rx Inspector, which he found on Reddit, he learned that the pills he had been taking were made in a factory in India cited multiple times by FDA inspectors for poor-quality manufacturing, including for shipping potentially contaminated medication to the U.S.
Drug safety experts caution that the same manufacturer can produce both good and bad batches, and that patients can react differently to the same drug for reasons unrelated to manufacturing. Doctors and pharmacists advise patients with concerns to talk to their health care providers and to not stop taking medication on their own.
Beeler said he has no idea what caused the reaction to his generic bupropion, but having access to information about the factory and its troubles with the FDA would have allowed him to make different choices.
“Having somebody say, ‘There’s big differences in the way that certain drugs are manufactured,’ it’s kind of like, I’m not that crazy,” he said. “It would have answered a lot of questions early on.”
In Chicago, Kate Wagner, 32, went on 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, she stopped taking stimulants altogether even though she had been on them since she was a child.
Wagner recently discovered Rx Inspector on X and learned that the generic was made at a U.S. factory found to have manufacturing violations during nine inspections from 2009 to 2022.
“I really felt like in my heart that it was just a bad drug,” said Wagner, who writes about architecture. “There’s a difference between an expected side effect and being made sick by medication.”
Dawn Levitt can’t take any chances — 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 look up her generic, she learned that it was made in an Indian factory faulted by the FDA for quality and safety lapses, including dirty drugmaking equipment and destroying records related to drug quality.
“I felt sick and anxious when I saw the violations,” said Levitt, who lives in Michigan and blogs about her medical journey. She said she quickly made plans to talk 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 poorly made drugs have already been steep.
Nineteen years ago, Staples lost her husband, Dennis, in one of the deadliest drug contamination breaches in U.S. history. Before receiving dialysis for complications from Type 2 diabetes, Dennis was given a dose of heparin, a generic blood thinner used by millions of Americans. Moments later, he collapsed in his chair and never regained consciousness.
Investigators later determined that some generic heparin contained a contaminated ingredient from China that could cause severe allergic reactions. Dozens of deaths and hundreds of serious injuries were reported among patients.
“I loved my husband with all my heart and dearly miss him every minute of every day with an ache that cannot be dulled or cured,” 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 them up, she said she was stunned.
Her blood pressure medication was 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 step, and demanded improvements.
Staples said it’s distressing 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 very wrong and alarming that we are not given full disclosure on the meds we are prescribed,” she said. “Nothing has changed.”
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This story originally appeared on ProPublica
