The calls came in one after another over the course of a month in 2004, with strikingly similar complaints. Some people told Oregon psychiatrist James Hancey that new generic drugs for depression were no longer working. Some described unexpected reactions, including dizziness, flu-like symptoms and electric shocks to the brain.
“That’s when I started thinking, ‘This drug is no good,'” Hansey said. “I get a lot of calls saying the exact same thing.”
Mr. Hancey suspected that generic drugs were ineffective and that patients were suffering from sudden withdrawal symptoms. But there was no easy way to find out exactly where the pills came from or the safety records of the factories that made them. He began compiling a “no-fly” list of dozens of generic drugs he suspected were dangerous or ineffective, largely based on patterns he observed in his own patients.
Well, he has another one.
Last month, ProPublica launched Rx Inspector, a free, searchable tool that allows doctors, researchers, and patients to trace specific generic drugs back to the manufacturer and review the factory’s testing history.
The researchers said they are using the tool to step up efforts to make the country’s drug supply safer. Health workers said they check factory records before writing prescriptions. And patients say it helped them understand what went wrong when their medications caused unexplained health problems or didn’t work at all.
“This is a godsend for researchers trying to study drug manufacturing,” said John Gray, a professor at Ohio State University who is working on a project funded by the U.S. Department of Defense to evaluate the safety and quality of generic drugs.
The Food and Drug Administration knows where generic drugs are made and inspects factories around the world, but the public is never allowed to easily know which manufacturers made which pills or whether those factories have a history of safety or quality violations.
Rx Inspector changes that. Based on records obtained from the FDA through ProPublica’s federal lawsuit against the agency and other sources, the tool links nearly 40,000 drugs to their original manufacturers, laboratory reports and regulatory actions that were previously difficult, if not impossible, for the public to find. On Friday, ProPublica published some of the underlying data on GitHub so other journalists and researchers can build on our research.
The tool is part of a months-long ProPublica investigation into the FDA’s failures to oversee the generic drug industry, particularly overseas factories that have repeatedly been at fault for drug contamination and other quality defects.
It is already changing the way people make decisions.
Gray and his team are working on assigning quality scores to generic drugs based on risk. The goal is to enable government purchasers, including the Centers for Medicare and Medicaid Services, to purchase drugs based on quality, not just cost. He said Rx Inspector allows the team to move faster and allows researchers to easily examine factory locations and inspection details.
Col. Vic Suarez, former Army Medical Supply Chain Commandant who is collaborating on the project, said the tool is also being used for research aimed at helping emerging U.S.-based pharmaceutical companies produce high-quality medicines.
Healthcare workers said the tool is changing the way they counsel patients.
Hancey, an Oregon psychiatrist, said he recently shared Rx Inspector with a hospital training director so residents could use it to research generic drugs and create their own “no-fly” lists. He also plans to improve his own list so he can more easily track the drug companies behind the generic drugs he’s most concerned about.
“Experience has taught us that not all generic drugs are the same,” he said. “And you don’t know who you’re dealing with. This eliminates a lot of paperwork.”
Ninety percent of prescriptions in the United States are for generic drugs, many of which are manufactured overseas. For years, pharmacists and lawmakers have asked the FDA to require manufacturers to identify themselves on the labels of pill bottles so that consumers and health care professionals can learn more about the drugs they use or prescribe.
The FDA resisted. The agency’s former head of drug safety told ProPublica that regulators don’t want to crack down on thousands of companies to ensure they’re providing accurate information.
The FDA requires companies to disclose the location of manufacturing when applying to sell generic drugs. However, that information is not published on the website. The agency also posts some inspection reports online, but it regularly redacts the names of the generic drugs involved, even when inspectors find significant safety or quality violations.
Rx Inspector aggregates these threads. Since the tool’s launch, ProPublica has heard from dozens of readers who have used it to research their own medications. They said they felt empowered and even vindicated after learning where their drugs were made and discovering the FDA’s longstanding concerns about substandard manufacturing in some cases.
John Beeler, a father of three in Atlanta, used Rx Inspector to learn more about the generic antidepressants that may have caused his illness. Provided by John Beeler
John Beeler, 49, of Atlanta, said he developed headaches and a rash on his sides, upper body and hands after he started taking bupropion, a generic version of the brand name Wellbutrin, one of the most widely used antidepressants in the United States.
During those two exhausting weeks in 2024, Beeler said he worried, “Is it because of the medication that I’m getting sick?”
The FDA has filed thousands of complaints about some generic drugs, according to government records. Tests by independent laboratories, including one commissioned by ProPublica, found that there are irregularities in the way the pills dissolve in the body, potentially allowing patients to receive too much medication or leave their symptoms untreated.
Mr. Boehler is a father of three children. I asked my doctor to switch me to another medication. The rash and headache cleared up quickly.
Bieler later used Rx Inspector, which he found on Reddit, to learn that the pills he was taking were made in a factory in India that had been cited multiple times by FDA inspectors for poor quality manufacturing, including when shipping potentially contaminated drugs to the United States.
Kate Wagner discovered that her ADHD generic drug was manufactured in a factory that had been cited repeatedly by FDA inspectors for safety and quality violations. Provided by Kate Wagner
Drug safety experts warn 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. Physicians and pharmacists advise patients with concerns to consult their health care provider and not to stop taking their medications on their own.
Bieler said he doesn’t know what caused his reaction to generic bupropion, but he could have made a different choice had he had access to information about the factory and the issues with the FDA.
“When someone says to me, ‘There’s a big difference in the way certain drugs are made,’ I feel like I’m not that crazy,” he says. “It would have answered a lot of questions early on.”
In Chicago, Kate Wagner, 32, said she took a new generic drug for attention deficit hyperactivity disorder last year and spent two weeks in a coma, barely able to move. The experience was so disorienting that she stopped using stimulants completely, although she had been taking them since childhood.
Wagner recently discovered an Rx inspector at X and learned that the generic drug was manufactured in a U.S. factory that had found manufacturing violations in nine inspections from 2009 to 2022.
“In my heart of hearts, I really felt this was just bad medicine,” said Wagner, who writes about architecture. “There’s a difference between expected side effects and getting sick from a drug.”
Dawn Levitt had no idea that the generic immunosuppressants that protect her heart were made in a troubled Indian factory. katherine daly
Dawn Levitt can’t take any chances. She relies on generic drugs to protect her fragile heart. She has had two heart transplants since 2006 and takes everolimus, a generic version of the immunosuppressant Zotres, to prevent rejection.
When Levitt used Rx Inspector to examine the generic drug, she discovered that it was manufactured in a factory in India that had been accused by the FDA of quality and safety deficiencies, including dirty drug manufacturing equipment and destroyed records regarding drug quality.
“Seeing the violations made me sick and worried,” said Levitt, who lives in Michigan and blogs about her medical history. She said she immediately made plans to talk to her doctors 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.”
Joanna Staples kissed her husband around 2005, several years before he died. “I loved my husband dearly,” she said. Courtesy of Joanna Staples
For Joanna Staples, the cost of poorly made medicines is already high.
Nineteen years ago, Ms. Staples lost her husband, Dennis, in the worst drug scandal in U.S. history. Before undergoing dialysis due to complications from type 2 diabetes, Dennis was given heparin, a generic blood thinner used by millions of Americans. After a few minutes, he collapsed into a chair and never regained consciousness.
Investigators later found that some generic heparin contained contaminated ingredients imported from China that could cause severe allergic reactions. Dozens of patients were reported dead and hundreds seriously injured.
“I love my husband with all my heart, and I miss him every minute of every day, with pain that cannot be dulled or cured,” Staples told a House subcommittee investigating the crisis in 2008.
Staples, now 73, takes several generic medications herself. When she recently examined them using Rx Inspector, she said she was stunned.
Her blood pressure medication was made in China. Last year, FDA inspectors found so many quality violations at the factory that the FDA issued a warning letter, a serious enforcement action, requiring improvements.
Staples said it pains her to know that nearly 20 years after her husband’s death, patients and doctors are still often kept in the dark.
“I think it’s very wrong and alarming that we’re not being fully disclosed about the medications we’re being prescribed,” she said. “Nothing has changed.”
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