“A Godsend”: ProPublica’s Rx Inspector Tool Is Helping People Find Critical Safety Information on Generic Drugs
This deserves loud pushback.
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 …
This deserves loud pushback.
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 …
“A Godsend”: ProPublica’s Rx Inspector Tool Is Helping People Find Critical Safety Information on Generic Drugs
This deserves loud pushback.
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 …
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