What the FDA Won’t Tell You About Your Medications

Summary

Podcast Summary: "What the FDA Won’t Tell You About Your Medications"

Paper Trail by ProPublica • Released: May 14, 2026
Host: Jessica Lussenhop
Guests: Debbie Senziper, Megan Rose (ProPublica Investigative Reporters)
Special Contributor: Janet Woodcock (Former FDA Drug Safety Head)

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Episode Overview

In this episode, investigative reporters Jessica Lussenhop, Debbie Senziper, and Megan Rose expose hidden, troubling realities behind the safety of generic medications in the United States. Drawing on a two-year investigation into FDA inspection records and patient experiences, the team reveals how the FDA withheld disturbing information about the overseas factories producing generics, and even allowed certain troubled plants to continue exporting drugs to the U.S. under secret exemptions—sometimes with life-or-death consequences for patients.

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Key Discussion Points & Insights

1. The Promised Parity of Generics vs Reality

• FDA Public Relations: The FDA has consistently assured the public that generic medications are as safe and effective as their brand-name counterparts, making up 90% of filled prescriptions in the U.S. ([01:20])
• Reporter Skepticism: Debbie Senziper and Megan Rose dig into this belief after hearing disturbing stories from FDA inspectors about conditions at overseas factories ([02:29], [03:02]).

2. Horrors Uncovered in Overseas Factories

• Inspection Reports: Factories in India and China—where much of the generic drug supply comes from—were described as “dirty,” with manufacturing breakdowns and contamination.
  • "Dirty water is collecting in buckets around the sterile area." – Megan Rose ([06:09])
  • "Metal shavings on equipment or urinals dripping... pigeons perched on wires and defecating in sterile areas." – Debbie Senziper & Megan Rose ([06:17]-[06:23])
• Testing Integrity Compromised:
  • Many drug companies were left to test their products themselves.
  • Reports of test record manipulation were common, e.g., results always just below reject limits.
  • "A factory worker actually shoved the results in their mouth and started chewing it... Another company had testing records that they put into a trash bag and poured acid over it." – Megan Rose ([07:53]-[08:22])

3. FDA’s Dilemma: Safety vs. Shortages

• Agency Compromises: When factories failed inspections, the FDA did not always ban them outright due to fear of drug shortages.
  • “If they banned all these factories and no one else was making those drugs, the US could run out.” – Jessica Lussenhop ([09:01]–[09:44])
• Secret Exemptions:
  • The FDA quietly granted exemptions to some banned factories so they could keep supplying crucial medications.
  • At least 20 factories with known problems were exempted, covering at least 150 medications ([10:22]-[12:09]).

4. Human Impact: Real Stories from Patients

• Patient Adverse Events:
  • The FDA’s own adverse event database contained thousands of complaints about drugs from exempted factories, including serious side effects and deaths.
• Joe’s Story ([14:09]-[15:52]):
  • Kidney transplant patient in Philadelphia unknowingly took tacrolimus manufactured in a troubled Indian factory.
  • Independent lab tests showed his pills often contained a lower dose and dissolved too quickly, both dangerous for transplant patients.
  • "We don't know if that's what caused Joe to need a second kidney, but it sure doesn't look good." – Debbie Senziper ([15:52])
• Hannah’s Story ([16:30]-[19:15]):
  • 21-year-old double-lung transplant patient whose tacrolimus levels fluctuated hugely based on manufacturer; after a transplant team switched her generics, she suffered organ rejection and died.
  • Her mother only found out after the fact about the manufacturing problems: “So, unfortunately... I was the one who told Holly that her daughter had been on not one, but two problematic generics of Tacrolimus.” – Megan Rose ([19:24])

5. Why Was the FDA So Secretive?

• Lack of Transparency: FDA kept the public, pharmacists, and even many within the agency in the dark about the exemptions ([21:59]-[25:16]).
• Decision-Making Concentration: A small group of mid-level bureaucrats made most exemption decisions with little internal oversight ([24:53]).
• Interview with Janet Woodcock ([26:41]-[29:14]):
  • Admitted secrecy: "It was an approach that we had... to prevent shortages."
  • On not informing the public: "I'm not sure that this would do anything for the citizens except cause them anxiety and trace back to the pharmacy and ask for a change... I just think that would add to the chaos." ([29:54])
  • No extra FDA tracking/testing of exempted drugs: "No, I don't think so." ([28:35])

6. The FDA’s Rationalization vs. Public Outrage

• Reasoning:
  • Avoiding shortages justified the secrecy and exemption policies, leaders argued.
  • Woodcock: "We did not believe that the drugs that we carved out from import bans were unsafe." ([27:42])
• Pushback:
  • “When we ran that argument by... doctors, pharmacists, patients, they were offended... People want to be empowered. We all want to know what we're putting in our bodies.” – Debbie Senziper ([30:11])
  • Suggests lack of transparency breeds mistrust, not just among the public but also medical professionals and regulators.

7. The Aftermath—Accountability and Change

• Congressional Response ([33:25]-[34:15]):
  • Senators Rick Scott (R) and Kirsten Gillibrand (D) called for investigations and reforms.
  • Proposed the Clear Labels Act: requires drug bottles to indicate manufacturing origin and known issues.
  • “It is wholly irresponsible that we're living in the dark when it comes to where our medicines are made.” – Debbie Senziper quoting lawmakers ([33:52])
• Actionable Tools for Patients:
  • Launch of ProPublica's "Rx Inspector" tool, which lets consumers look up their medication’s factory of origin and any inspection reports or issues ([34:36]-[35:54]).
  • Real-patient feedback after the investigation: at least one transplant patient was able to identify and change their generic drug supplier with positive health outcomes ([36:09]).

8. Reflections on the Larger System

• “The hope, and I think this is probably more than hope, it's fact is that the majority of generic drugs coming into the United States are safe and effective... these are exceptions.” – Debbie Senziper ([36:30])
• The team cautions not to panic or stop taking prescribed medications but to advocate for awareness and empowerment.

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Notable Quotes & Memorable Moments

• “If you take a generic drug, it is just as safe and effective as a brand name drug... But when I was hearing stories from inspectors... I thought, how is that promise possible?”
  — Debbie Senziper, [02:29]

• “Dirty water is collecting in buckets around the sterile area.”
  — Megan Rose, [06:09]

• “A factory worker actually shoved the results in their mouth and started chewing it... to prevent the inspector from seeing it.”
  — Megan Rose, [07:53]

• “Some of the most troubled drug makers in the world [were allowed] to continue shipping their drugs here, despite all the problems identified by inspectors.”
  — Debbie Senziper, [10:42]

• “Joe’s pills contained a lower dose of the key ingredient than they were supposed to... that kind of underdosing can leave patients vulnerable to organ rejection.”
  — Debbie Senziper, [15:05]

• “No, I don't think so.” (on whether the FDA did anything extra to track drugs from exempt factories)
  — Janet Woodcock, [28:35]

• “I'm not sure that this would do anything for the citizens except cause them anxiety... I just think that would add to the chaos.”
  — Janet Woodcock, [29:54]

• “People want to be empowered. We all want to know what we're putting in our bodies.”
  — Debbie Senziper, [30:11]

• “Nobody really knew about this, and shouldn't we have known?”
  — Debbie Senziper, [38:07]

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Timeline: Timestamps for Major Segments

• 00:02–02:29: Introduction, overview of generic drug safety and FDA's public stance
• 05:18–06:44: Shocking inspector findings about overseas factories
• 07:19–08:33: How companies hide problems and falsify results
• 09:44–12:09: FDA’s secret exemptions to prevent shortages
• 13:21–16:30: Personal stories: Joe and Hannah’s medical lives upended
• 23:36–25:16: FDA policy and bureaucracy behind exemption decisions
• 26:41–29:54: Interview with Janet Woodcock; rationale and secrecy about exemptions
• 33:25–34:15: Congressional reaction and the push for new labeling laws
• 34:36–36:09: ProPublica's Rx Inspector tool and patient impact
• 36:30–38:14: Reflections on trust, accountability, and the call for transparency

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Episode Takeaways

• The FDA, in its quest to balance drug availability with safety, allowed certain troubled factories to continue supplying the U.S., hiding key safety information from the public and even healthcare providers.
• Real patients suffered sometimes catastrophic consequences while lacking vital information needed to advocate for themselves.
• This investigation has led to congressional action and new resources for consumers—reminding listeners of the power and necessity of investigative journalism to challenge institutions and spur change.

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Explore your own medications’ safety: propublica.org/rxinspector

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“Shouldn't we have known?” – Debbie Senziper, [38:07]

Transcript

[Jessica Lussenhop]

ProPublica Investigative journalism in the Public Interest. Hi, my name is Jessica Lussenhop and I am an investigative reporter at ProPublica. If you've never heard of us, we've been around since 2007. We're an independent nonprofit newsroom and investigations are our bread and butterfly. It's all we do. We have reporters all over the country. Special shout out to the Midwest bureau, where I have been the Minnesota correspondent for the past several years. Midwest is best, but we're also in the Southwest, the Pacific Northwest, in California, in Texas and the South. When people in power abuse your money, your time, your trust, that's when we show up, possibly in your backyard. And on this show, I want to share with you this feeling I get all the time when I'm talking to my colleagues. They tell me what they're working on and it just breaks my brain. It makes me look at my life differently. And the investigation we're going to tell you about on this episode is a perfect example. It starts with something you probably have in your house right now. A generic medication. Meet Blue. Blue's not feeling well. The prescription generic medication Blue Wonders do they really work as well as name brands? This is a PSA that the U.S. food and Drug Administration put out years ago about generic drugs. Generics are the cheaper version of name brand the drugstore acetaminophen versus Tylenol. 90% of prescriptions filled in the US are four generics. And in this PSA, the FDA is saying there's nothing to worry about. Generics and name brand medications do work the same. Even though they may look different, generics have the same key ingredients. FDA approval is equally rigorous for generics to make sure they're as safe and effective as name brands. I've got four or five generics in my house right now, and I never gave them much thought. I didn't think I needed to. But my colleagues at ProPublica spent about two years diving deep into the FDA's own records and they discovered something that actually scares me.

[Debbie Senziper]

For decades, the US Government has promised, and we all grew up believing that if you take a generic drug, it is just as safe and effective as a brand name drug. But when I was hearing stories from inspectors who had spent months or years going from one factory to another in remote areas of China and India and other countries and describing what they saw, I thought, how is that possible? How is that promise possible?

[Jessica Lussenhop]

This is a story about a powerful government agency that's in charge of keeping us safe, withholding scary information about our Medications, the stuff we put into our bodies every day. So we're gonna do what the f. FDA won't tell you, where our generic medications come from and the truth about the factories that made them.

[Debbie Senziper]

That's what we do as investigative reporters. We look under rocks for secrets, what's not being told? And, you know, we found a pretty big one here.

[Jessica Lussenhop]

My name is Jessica Lussenhop. This is Paper Trail.

[Debbie Senziper]

So every editor and reporter on this project ran to their medicine cabinets early on.

[Jessica Lussenhop]

This is Debbie Sensiper. Like Bob Woodward at the Washington Post.

[Megan Rose]

Debbie Senziper is this type of reporter from the Latin for to track.

[Jessica Lussenhop]

Carrie.

[Megan Rose]

What is investigative Good.

[Debbie Senziper]

My kids love that, by the way. They didn't care about the Pulitzer prize, but, boy, the jeopardy Thing that that got them.

[Jessica Lussenhop]

She became a big enough deal to wind up on Jeopardy. By taking big swings at powerful people and institutions. She's uncovered housing corruption in Florida and exposed how the world's elite hide their wealth in secretive shell companies. Her reporting has changed laws, and she also runs an investigative lab at Northwestern University's Medill School of Journalism.

[Megan Rose]

I think, like many investigative reporters, I'm very motivated by outrage.

[Jessica Lussenhop]

And this is Megan Rose, another Investigative Reporter at ProPublica. She is also a Pulitzer prize winner. Her work has helped clear the records of falsely convicted men and exposed Navy safety protocol failures that cost the lives of sailors. She and Debbie teamed up to look

[Megan Rose]

into the fda, and what had been reported showed that, like, we should probably be a little more worried about our generic drugs than our government is leading us to believe.

[Jessica Lussenhop]

Debbie and Megan had heard horror stories about generic drugs from the FDA's own inspectors. The FDA employs a small army of inspectors who are experts in drug manufacturing, and they fly all over the world to investigate factories, making sure everybody's doing what they're supposed to. Many of these factories are overseas in India and China.

[Debbie Senziper]

When I heard stories and saw pictures of what our inspectors were finding overseas, I mean, in some cases, honestly, it makes your skin crawl.

[Jessica Lussenhop]

In theory, areas of these factories should be as sterile as an operating room. But Megan and Debbie read through hundreds of inspection reports, and that really wasn't the case. At some of these factories, inspectors described them as being dirty and having manufacturing breakdowns.

[Megan Rose]

There are lots of reports of, like, here is one that says dirty water is collecting in buckets around the sterile area.

[Debbie Senziper]

Metal shavings on equipment or urinals dripping

[Megan Rose]

near the sterile concrete.

[Debbie Senziper]

I mean, like, really gross pigeons perched on wires and defecating in sterile areas.

[Megan Rose]

So we were, like, discovering all of These things. And Debbie and I would call each other and be like, oh, my God, I have to read you this from this inspection report. It would be so gross.

[Jessica Lussenhop]

I want to make a note that I will never get that pigeon thing out of my head for the rest of my life.

[Debbie Senziper]

Yes.

[Jessica Lussenhop]

In addition to just writing down the things they observed, inspectors would also check to see if the factories were testing their drugs properly. And this part really surprised me. It turns out the FDA doesn't regularly test generic drugs that are coming into the US to make sure they are safe and effective. It just lets the companies do the tests themselves. But the inspectors found serious issues with some of these tests, too. Like in this report, talking about testing records from a factory in India.

[Megan Rose]

They, quote, appeared to be routinely manipulated by your manual visual inspectors to stay just below the established reject particle limits set. So all those words are essentially, there's a limit for how much things like black particles or fiber or glass can be in the injectable and still be safe. And they were always saying that it was just under the limit, like, everything was okay, regardless of whether it was okay or not. And then those drugs get shipped to

[Jessica Lussenhop]

the U.S. i mean, they're cheating.

[Megan Rose]

They're cheating. And in some of the stories we heard that the inspectors were looking at testing records at one point, and a factory worker actually shoved the results in their mouth and started chewing it. No, to prevent the. Yeah, to prevent the inspector from seeing it. What? This is crazy. Another company had testing records that they put into a trash bag and poured acid over it.

[Jessica Lussenhop]

What?

[Megan Rose]

Yeah, it's kind of crazy.

[Jessica Lussenhop]

If you think about all this stuff. It's, like, cartoonish.

[Megan Rose]

It is. Debbie and I kept saying, this is like a movie, like, really shoving it into your mouth.

[Debbie Senziper]

And so when you hear these stories, it's like, wait, what? How is this happening? These are the drugs that we rely on for everything from blood pressure medication to cancer drugs to drugs that children take. And how is it possible that in some ways, they're being made this way? And honestly, the more I heard, the more I knew we had to dig deep.

[Jessica Lussenhop]

After hearing all of this from inspectors, Megan and Debbie asked themselves the next logical question. If the FDA's own inspectors were presenting the agency with these horror stories, saying the drugs from these factories could be ineffective or even dangerous, what was the FDA doing about that?

[Debbie Senziper]

What the FDA did over the years is they started banning the worst of the worst.

[Jessica Lussenhop]

The agency has the power to ban foreign factories from shipping their generics to the United States. But Debbie and Megan found out that the FDA then had a problem. If they banned all these factories and no one else was making those drugs, the US could run out.

[Debbie Senziper]

If you're a parent whose kid needs a generic drug and there's a shortage, there's nothing you wouldn't do to get it. And so the FDA has been hauled before Congress and taken down for drug shortages. Why can't you prevent drug shortages? So the last thing the FDA wants to do is ban a factory that makes important generic drugs for the US. The problem is, is that some of those factories, according to the FDA's own inspectors, aren't making these drugs. Well, so what do you.

[Jessica Lussenhop]

A former FDA inspector told Debbie and Megan that to solve this problem, the FDA made kind of a huge compromise. In some cases, if a banned factory was making a high demand drug, the FDA quietly gave them an exemption from the ban for that drug, allowing some

[Debbie Senziper]

of the most troubled drug makers in the world to continue shipping their drugs here. Despite all the problems identified by inspectors,

[Jessica Lussenhop]

Debbie and Megan started hunting for those exemptions. Which of these factories, with mold and dirty water and fake test results, were still sending drugs to the U.S. that wasn't an easy question to answer. The FDA puts out an obscure list online of the factories under a current band, and the exemptions are buried in pages and pages of jargon. When Megan and Debbie asked for a complete list of all the times this has ever happened, the FDA said, we don't have one. So Megan and Debbie created one themselves. With the help of ProPublica's data team, they dove into the Internet archives and found that more than 20 banned factories were given these exemptions. All told, these factories were allowed to keep shipping at least 150 medications or their ingredients to the US. Just to be clear, that's a small percentage of all the generic drugs that are sold in the us but still a lot of people were relying on these medications. So who were they and what happened to those patients?

[Megan Rose]

The FDA has a database for what they call adverse events. So essentially like you have taken a drug and you have had some sort of unexpected side effect and you can report this, doctors can report it, patients can report it. And there was thousands and thousands of complaints for these exempted drugs. Wow. Yeah, it was a lot. And it was a range of things everywhere from like, this smells really bad all the way up to death. But the adverse events don't give you names. So like we couldn't like go find these people and say, hey, tell me about that time you were hospitalized because you took a Bad drug.

[Debbie Senziper]

And so Megan and I and all of my students started looking for threads on social media about those drugs. They found patients all over the United States who were saying, something's up with my drug. I was switched from the brand name to a generic drug, or from one generic to another generic. I broke out in hives. My depression returned. My stomach started hurting. The consistency was off. Something's up. Something's up. And patients, you know, took to social media because they couldn't get answers anywhere else.

[Jessica Lussenhop]

While they were sifting through social media, Megan and Debbie zeroed in on one drug in particular. Tacrolimus. Transplant patients take it to prevent organ rejection.

[Debbie Senziper]

It's a life saving drug. It essentially keeps them alive. And what we found in our reporting is Tacrolimus, by one manufacturer, had been exempted from import bans. And so I remember Megan and I were thinking early on, wow, that's certainly a drug that you don't want there to be anything wrong with when it's being used by transplant patients to protect their new organs. And yet the FDA had allowed one of the most troubled factories in India to continue shipping that drug to the United States. And that's how I found Joe.

[Jessica Lussenhop]

Tell me about Joe. Who is he?

[Debbie Senziper]

Joe? He's a father who lives in Philadelphia with his wife and son. And he had a kidney transplant. And all of the sudden his kidney started to fail. What he didn't know was that the FDA had inspected the factory that made his medication like eight times since 2015, and they had uncovered quality problems in every case.

[Jessica Lussenhop]

Wow.

[Debbie Senziper]

So basically, he had been taking Tacrolimus from one of the most troubled factories in India. Had no idea.

[Jessica Lussenhop]

Just because that factory had a history of inspection issues didn't necessarily mean that Joe's pills were bad. So to figure out if they were, ProPublica decided to do something pretty cool, in my opinion. We hired a lab to test Joe's pills.

[Debbie Senziper]

There were two problems with Joe's pills. And what they found was that some of his pills contained a lower dose of the key ingredient than they were supposed to.

[Jessica Lussenhop]

Holy shit.

[Debbie Senziper]

Yes. And that the pharmacists and the doctors that we interviewed said that kind of underdosing can leave patients vulnerable to organ rejection. They also found when we tested these pills, Joe's pills, that the capsules dissolved too fast, up to three times faster than the name brand. And that that kind of rapid dissolution can introduce too much of the drug too quickly, which could cause kidney failure.

[Janet Woodcock]

Wow.

[Debbie Senziper]

You know, we're not God. We don't know if that's what caused Joe to need a second kidney, but it sure doesn't look good. And I was able to tell him all of that. And that's when he started putting two and two together and saying, gosh, I wonder if I was taking a bad drug. And Joe Demaio, like millions of other Americans, will never know the answer to that question. And then Megan will tell you about Hannah. I mean, that. That one is just. I mean, you know, Joe survived. Joe survived.

[Jessica Lussenhop]

Megan heard from a transplant pharmacist about a young patient of his named Hannah who had died at just 21 years old. She'd also received an organ transplant, two lungs, and had been taking the same kind of generic tacrolimus that Joe had been taking. The pharmacist put Megan in touch with Hannah's mom to talk about what happened.

[Megan Rose]

Hannah was diagnosed as a child with cystic fibrosis, which is a genetic disease that largely impacts the lungs, makes it difficult to breathe. But Hannah had always been relatively healthy. She played soccer. She even graduated high school a year early. The summer she graduated, she went on a cruise with her family to celebrate. And unfortunately, she caught an infection. And it quickly escalated to the point where she was gravely ill on a ventilator in the icu, and it was gonna take a new set of lungs to save her life. After the transplant, Hannah went through a pretty tough journey to recover. But her overall prognosis was good. Hannah could breathe again. And she got to the point where she started taking college courses. But there was one thing for Hannah that wasn't ever quite right. That was the amount of tacrolimus in her system. It was always pretty erratic. Her transplant team noticed that depending on what generic manufacturer she was taking, the amount of medicine in her body would be different, and they would expect it to just always stay pretty steady. Several years after her transplant, she started having trouble breathing again. At first, it felt like she was breathing through a straw, and then her chest got tighter, and it felt like she was breathing through one of those small straws you use to stir your coffee. Wow. And her doctors diagnosed that she was in rejection. Her transplant team thought that it was the generic tacrolimus that might be to blame. Hannah deteriorated really rapidly to the point that she needed another transplant to survive. But she got so sick, she got so weak so fast. Her transplant team made the really tough call that they weren't going to offer her a second transplant. They just didn't think she was gonna survive. Oh, wow. Her mom, Holly, who had always been her fiercest advocate called every hospital she could to try and get her into another transplant program. And there was one other place that she could try, but Hannah decided that she was done fighting. She didn't want to start over with a new team. They took her off the ventilator, and she died shortly after.

[Jessica Lussenhop]

How much did her mom know about what was going on with the drugs that Hannah was on when you started talking to her?

[Megan Rose]

So, unfortunately, what happens sometimes in investigative journalism is you end up being the messenger of some really terrible news. And I was the one who told Holly that her daughter had been on not one, but two problematic generics of Tacrolimus. In fact, the entire time after her transplant, she'd only been on the two generics that were known to have problems. So, you know, she was. Holly's been left to wonder, you know, if she had just known that information, could she have done something different?

[Jessica Lussenhop]

What was that like to tell her?

[Megan Rose]

It was really. It was really hard. You know, I always feel like I owe it to sources to let them know what I know. It's hard to look a mom in the eyes and say, you've already had this tragic thing happen. You've lost your daughter at 21 years old, and now I'm going to be the one to tell you that maybe something might have been different had her drugs been different? We don't know that. I'm a mom myself of two young boys, and I think mother to mother, it was not a fun conversation. It's not. It's the least favorite part of my job.

[Jessica Lussenhop]

Why was it Megan's job to deliver this kind of news? She was sharing information that conceivably the FDA could have. Why was the FDA being so secretive about this? That's next. The newsroom behind this podcast. ProPublica is the largest nonprofit investigative newsroom in the country. We report on corruption and abuses of power because when the facts are clear, people can make real change. Our reporting has held officials accountable. It's exposed dangerous failures in hospitals and immigration detention centers. It's revealed how the ultra wealthy use legal loopholes to avoid paying taxes. And everything we publish, including this podcast, is free. It's investigative journalism for the people, not for profit. Find out [e-mail].

[Debbie Senziper]

Right now, we are living through some of the most tumultuous political times our country has ever known. I'm David Remnick, and each week on the New Yorker Radio Hour, I'll try to make sense of what's happening alongside politicians and thinkers like Cory Booker Nancy Pelosi, Liz Cheney, Tim Waltz, Ketanji Brown Jackson, Newt GT F. Kennedy Jr. Charlemagne, the God, and so many more. That's all in the New Yorker Radio Hour, wherever you listen to podcasts.

[Jessica Lussenhop]

Megan and Debbie had uncovered these heartbreaking stories and now had good reason to believe that the FDA's strategy had hurt the public. They wanted to know who at the FDA could have let this happen. But they also wanted to make sure that they were being fair. The FDA had kept troubling information from people taking these problem drugs, but they'd done it in theory to prevent drug shortages.

[Megan Rose]

We were having to ask ourselves, like, is it reasonable for the FDA to do this? Like, a shortage of drugs is not something that's good for the country.

[Jessica Lussenhop]

Megan and Debbie took this question to the fda. How close had the US been to running out of certain drugs? And the FDA wouldn't share any of that information. And then one of their sources, a former FDA inspector, gave them a piece of very valuable context. According to him, the whole problem could have been avoided.

[Megan Rose]

You know, he said to us, it's the FDA's fault that we got here. And Debbie and I were like, well, how is that? He said, well, they kept approving these companies to make more and more generic drugs, even though they knew that they were so bad at making drugs safely. And so then these companies were gobbling up more and more of the market, meaning we were becoming more and more dependent on them.

[Jessica Lussenhop]

If the FDA had stopped troubled factories from sending drugs earlier, other companies could theoretically have entered the market. We wouldn't have been so reliant on the problem factories in the first place, or they would have been forced to clean up their act.

[Megan Rose]

And so Debbie and I looked at each other and were like, whoa. Like this is a problem of the FDA's own making. Which was like a huge, aha, big moment for us in our reporting.

[Jessica Lussenhop]

Megan and Debbie spoke to people higher up at the FDA who had tried to get the agency to change course. One source told them he'd literally yelled at FDA leadership about these decisions and then quit when they wouldn't change their minds when it came to exemptions. Debbie and Megan realized that somehow not everybody inside the FDA even knew what was going on.

[Debbie Senziper]

And what we found was that a small group of mid level bureaucrats were basically given this extraordinary power by the head of drug safety at the FDA to make these decisions, and that these were people primarily, but not in every case, who were in charge of preventing drug shortages.

[Jessica Lussenhop]

For many years, that head of drug safety was Janet Woodcock.

[Debbie Senziper]

She worked her way up as a woman at a time when women were not in leadership positions at the fda. She really was known for pushing breakthrough brand name drugs to market. She was very innovative that way. She had a really strong reputation in that regard. But she was there for a very, very long time. And so the exemptions that we uncovered in large part happened under Dr. Woodcock.

[Jessica Lussenhop]

The FDA provided Congress with annual reports on drug shortages, but the fact that they were giving some companies exemptions wasn't even mentioned for more than a decade. Janet Woodcock had since retired, but Debbie and Meghan decided they had to talk to her to understand why this policy had been so secretive.

[Debbie Senziper]

One of our top editors said one day to Megan and I get in the car and go knock on her door.

[Megan Rose]

And then getting to her house and there's a security gate, so we like literally cannot door knock her.

[Debbie Senziper]

So it was a miss. We didn't know what to do. So we pulled over two blocks away and decided to call her.

[Megan Rose]

And she picks up.

[Janet Woodcock]

Yeah. Between field and headquarters, there were a lot of tensions all the time because the field people really couldn't understand. Like I said, we saw this problems, like, why, why aren't you just completely shutting them down? They thought that the center was like soft on crime.

[Megan Rose]

Right. Janet was like, okay, let's talk. Any question that was one of my

[Janet Woodcock]

main roles is like deciding things that people were disagreeing about.

[Debbie Senziper]

The best part of your job.

[Janet Woodcock]

That was my job. That was a lot of my job.

[Debbie Senziper]

Right. She really said, look, I've got nothing to hide. Here's why we did this.

[Janet Woodcock]

It was an approach that we had, let's put it that way, to prevent shortages.

[Debbie Senziper]

And we felt like, you know, we had a higher calling here. We did not want to interrupt the flow of generic drugs to the United States.

[Janet Woodcock]

People start scalping drugs, they'll start getting black market drugs that maybe aren't even the drug. I mean, right. We've seen some really bad things in our time when there's shortages.

[Debbie Senziper]

We did not believe that the drugs that we carved out from import bans were unsafe.

[Janet Woodcock]

Huge, huge majority of drugs on the US Market are perfectly fine.

[Jessica Lussenhop]

But even if that's the case, what about all those drugs shipped here from banned factories? And what about all the reports they'd seen from doctors and patients about bad reactions?

[Debbie Senziper]

Janet Woodcock acknowledged that they were not actively looking at their own reports of harm to see if there were problems with these exempted drugs. They weren't independently testing these drugs as they were coming in The United States, and those guardrails just simply were not in place. Did you do anything extra to track those drugs from those particular factories?

[Janet Woodcock]

No, I don't think so.

[Debbie Senziper]

Okay. They kind of relied on the companies themselves to do some extra testing and to say, don't worry. These drugs that you've exempted from import bans, we've done some extra testing, they're fine.

[Janet Woodcock]

We were pretty, you know, confident in the testing that we wouldn't have, quote, a really bad drug.

[Debbie Senziper]

And, you know, when we asked her. But hold up. Did you tell people about this, who knew about this? That's where things got a little bit complicated. Did you tell. Did the FDA tell pharmacists and hospitals and doctors to keep a lookout, or did they know about these carve outs?

[Janet Woodcock]

I don't think so, no.

[Megan Rose]

When we asked her, like, why would you not tell the public that you're making these exemptions? Like, you think that you have really good reasons for making them. You were in between a rock and a hard place. And this was just what the FDA had to do. So I was like, why not say that? And she thought, well, it would have created quite a quote, a frenzy.

[Debbie Senziper]

She was also very open with, well, hold up. Let's just say we did make this information public. What can the public do with it? We don't want to create panic in the pharmacies. And so really, is it information that the public needs to know?

[Janet Woodcock]

I'm not sure that this would do anything for the citizens except cause them anxiety and trace back to the pharmacy and ask for a change of generic or whatever. And I'm not sure. I mean, I just think that would add to the chaos. But, you know, other people feel differently about it. I understand.

[Debbie Senziper]

And when we ran that argument by many, many sources, doctors, pharmacists, patients, they were offended by the argument. And the reason they were offended is because people want to be empowered. We all want to know what we're putting in our bodies.

[Megan Rose]

I understand you have to be strategic in public health messaging, but I was surprised. It's just like such a lack of faith in what the public is capable of doing.

[Jessica Lussenhop]

I think that we're living in conspiratorial times here. And I think when you think about, you know, powerful people withholding information from the public, you can sort of quickly start sounding like sort of a tinfoil hat type person. And there's something about this high powered federal agency, a high powered person within that federal agency, who has decided the public doesn't need to know this or that. This information needs to be kept to a certain extent under wraps. That just feels sinister.

[Debbie Senziper]

And I know why you'd feel that way. And everyone we spoke to said the same thing. There was no corruption here. The FDA just wants to be considered the best drug regulator in the world. What we did find, and our sources describe this to us over and over again, is an agency that does not want to be second guessed. It's an agency that has long had this reputation of being the toughest drug regulator in the world. Trust us, we've got you. Your generic drugs are just as safe and effective as brand name drugs. And our sources over and over again said the same thing. The FDA does not want to be questioned.

[Jessica Lussenhop]

In a response to ProPublica, a spokesperson for the FDA wrote that the exemptions given to banned factories are, quote, thoroughly evaluated through a multidisciplinary approach. The agency said it requires manufacturers to conduct additional quality checks with third party oversight before sending drugs to the U.S. sometimes that means hiring independent labs for testing. It did not respond to questions about how those decisions were made or how the drugs were evaluated. In statements and emails to ProPublica, drug companies said that they take patient safety seriously, adhere to quality standards and are committed to working with the FDA on any regulatory issues. The manufacturers of Tacrolimus said their versions of the drug were safe and effective. One company also questioned the results of test results ProPublica commissioned, saying the lab didn't use an FDA approved testing method. After this reporting came out, some of the most powerful senators in the country took note. In a pretty damning report and letters to the fda, they demanded more information about the exemptions. And that was just the start.

[Debbie Senziper]

The U.S. special Senate Special Committee on Asia will now come to order.

[Jessica Lussenhop]

Last year, this committee exposed.

[Debbie Senziper]

Now it seems there's this bipartisan effort in the Senate to really make changes. And so Senator Rick Scott and Senator Kirsten Gillibrand have basically sent letters. We sent letters to the Food and

[Jessica Lussenhop]

Drug Administration, the Department of Veterans affairs

[Debbie Senziper]

and key industry stakeholders saying we want there to be more quality testing. We want to know when you're exempting these drugs.

[Jessica Lussenhop]

It is wholly irresponsible that we're living

[Debbie Senziper]

in the dark when it comes to where our medicines are made. In many cases, you can't figure out by looking at the label on your generic drugs exactly where that drug was made and whether that factory had a history of contamination problems and quality lapses. This is why I'm taking action to

[Jessica Lussenhop]

address these threats immediately with the introduction

[Debbie Senziper]

of my Clear Labels act. They Proposed legislation called the Clear Labels act, which would provide more information about where drugs are made on medicine bottles. So there's been, you know, a ton of strong reaction to these stories, and I think that there might be some real change.

[Jessica Lussenhop]

In response to the bill, a trade group for generic drug companies said the new labeling requirements would add, quote, significant costs in exchange for limited returns. You don't have to wait for this legislation to go into effect, though, to find out more about your own generic medications. Megan and Debbie teamed up with the data specialists here, here at ProPublica to make a website called the Rx Inspector. You can look up your own medication and find out where it was made. If there have been issues at the factory, you can pull up the inspection reports and read them for yourself. My colleague Brandon Roberts led the team that assembled this one of a kind tool. He spent a year learning the inner workings of FDA data and then he and his entire team built the Rx inspector in just three months. You can try it [e-mail] Rx inspector and there's one more thing that happened after we published these stories. Megan and Debbie started hearing from readers who were on the generics they wrote about. Two were even transplant patients who were having issues with their Tacrolimus, the drug that prevents organ rejection.

[Megan Rose]

And for one in particular, he had had issues with his tacrolimus in that his levels were low and he read our story, switched his manufacturer, and his levels went back up and were normal and he's okay.

[Debbie Senziper]

That's incredible.

[Jessica Lussenhop]

I don't know, when you step back from all of this, like, what, what do you make of everything you did? What do you feel like it tells us about our pharmaceutical system or about how we think about and take drugs?

[Debbie Senziper]

The hope, and I think this is probably more than hope, it's fact is that the majority of generic drugs coming into the United States are safe and effective. And so we don't want to scare people by saying these are horrible factories and these are terrible drugs. You know, these are exceptions. And one of the worst things that could happen is if people who rely on their drugs just stop taking them because they're afraid. Right. So I personally don't panic when I go to my medicine cabinet. However, I checked my medicine and I know I'm not taking anything from one of the factories that we wrote about. And that was really why we told these stories, to empower people to make, make good choices.

[Jessica Lussenhop]

I think there's something about this story that's so interesting to me because you get people mistrusting science and mistrusting doctors and then making sort of questionable decisions about their own health and how they're gonna deal with it. Sort of outside of the realm of science and medicine. But it's kind of stuff like this that creates that mistrust. It is an institution like the FDA being like, you don't need this information. Like, you know, like, it just kind of goes around and around, and we all sort of suffer the consequences of that.

[Megan Rose]

Absolutely. I mean, this idea that the government knows best is naturally going to be questioned by folks like, that's what we do as investigative reporters. Like, it's my whole job exists, really, because we need to be able to question the people that are in power. And so this idea that we just. Shouldn't we just trust them? It does not work out well.

[Debbie Senziper]

I mean, nobody really knew about this, and shouldn't we have known?

[Jessica Lussenhop]

Ooh, that gave me chills.

[Megan Rose]

This episode was produced by me, Sabi Robinson. Kathryn Wells edited this episode. Sound design and mixing by David Herman. Music by Julian Sartorius, Filippo Ansaldi and Simone Sims Longo with additional music by Epidemic Sound. Senate hearing audio from the U.S. senate Special Committee on Aging. Our team also includes Julia Longoria and Gabrielle Burbet. As we were putting the final touches on this episode, we learned that this investigation was named a finalist for the Pulitzer Prize. Again, if you want to find information about your own generic drugs, you can go to propublica.org rxinspector and look up your own pills, or just search Rx inspector.

[Jessica Lussenhop]

All right, so let's give this a whirl. I'm going to try to look these pills up using ProPublica's new tool. Okay, so if I click on that and then if I scroll down, there's an inspection history here. An inspector documented issues at the facility. At last inspection, it.