What the FDA Won’t Tell You About Your Medications

Description

For years, the Food and Drug Administration told the public that generics are just as safe and effective as brand-name medications. But ProPublica reporters uncovered reports from the FDA’s own inspectors detailing everything from pigeons pooping onto boxes of sterilized equipment to evidence of a factory cheating on quality testing. Even though the FDA knew about these reports, it let some of those troubled factories overseas keep shipping their drugs to the U.S. — some of which might have ended up in your medicine cabinet.

This episode details why and how a secretive group inside the FDA made the decision to keep this information from the public and how you can find out where your own medications are made.

Transcript

Editor’s Note: “Paper Trail” is produced as an audio series. If you are able, we encourage you to listen to the series. Transcripts are for reference only and may contain typos. Please confirm accuracy before quoting.

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 butter; it’s all we do. We have reporters all over the country — special shoutout 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. 

FOOD AND DRUG ADMINISTRATION, “Meet Blue: Generic Medications PSA”: Meet Blue. Blue’s not feeling well. The prescription: generic medication.Blue wonders, Do they really work as well as name brands? 

Lussenhop: This is a PSA that the U.S. Food and Drug Administration put out years ago about generic drugs. Generics are the cheaper versions of name brand drugs. The drugstore acetaminophen vs. Tylenol. Ninety percent of prescriptions filled in the U.S. are for generics. And in this PSA, the FDA is saying: There’s nothing to worry about. 

FOOD AND DRUG ADMINISTRATION, “Meet Blue: Generic Medications PSA”: Yes. 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 …

Lussenhop: 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 Cenziper: For decades, the U.S. 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?

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 going to do what the FDA won’t: tell you where our generic medications come from and the truth about the factories that made them. 

Cenziper: 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.

Lussenhop: My name is Jessica Lussenhop. This is “Paper Trail.” 

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

Lussenhop: This is Debbie Cenziper.

JEOPARDY, Alex Trebek: Like Bob Woodward at The Washington Post, Debbie Cenziper is this type of reporter from the Latin for to track. Carrie?

JEOPARDY, Carrie: What is investigative?

JEOPARDY, Trebek: Good. 

Cenziper: My kids love that, by the way. 

Lussenhop: Haha! 

Cenziper: They didn’t care about the Pulitzer Prize, but boy, the “Jeopardy” thing, that, that got them.

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.

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 into the FDA.

Rose:  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.

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. 

Cenziper: 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.

Lussenhop: Much 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. 

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

Cenziper: Metal shavings on equipment.

Rose: Or urinals dripping near the sterile factory. 

Lussenhop: Ugh! 

Rose: I mean, like, really gross. 

Cenziper: Pigeons perched on wires and defecating in sterile areas. 

Rose: So we were, like, discovering all of these things and then 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.

Lussenhop: I wanna make a note that I will never get that pigeon thing out of my head for the rest of my life. 

Cenziper: Yeah. Yes. 

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 U.S. 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.

Rose: They, quote, “appear 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 OK, regardless of whether it was OK or not. And then those drugs get shipped to the U.S.

Lussenhop: I mean, they’re cheating. 

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.

Lussenhop: No!

Rose: To prevent the insp— Yeah. To prevent the inspector from seeing it. 

Lussenhop: What?

Rose: Like, this is crazy. Another company had testing records that they put into a trash bag and poured acid over it.

Lussenhop: What!

Rose: Yeah. It’s kind of crazy if you think about all this stuff.

Lussenhop: It’s, like, cartoonish. 

Rose: It is! Debbie and I kept saying this is like a movie, like, really, shoving it into your mouth?

Cenziper: 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.

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? 

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

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 U.S. could run out.

Cenziper: 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 U.S. 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 do?

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.

Cenziper: Allowing some of the most troubled drugmakers in the world to continue shipping their drugs here, despite all the problems identified by inspectors.

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 ban, 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 U.S. Just to be clear: That’s a small percentage of all the generic drugs that are sold in the U.S. But still, a lot of people were relying on these medications. So, who were they? And what happened to those patients? 

Rose: The FDA has a database for what they call adverse events. So essentially, like, you have taken a drug and you’ve 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. 

Lussenhop: Wow. 

Rose: 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 ’cause you took a bad drug.

Cenziper: 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 the 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.

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. 

Cenziper: It’s a lifesaving 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.

Lussenhop: Tell me about Joe. Who is he?

Cenziper: Joe, he’s a father who lives in Philadelphia with his wife and son, and he had a kidney transplant. And all of a 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. 

Lussenhop: Wow.  

Cenziper: So basically he had been taking tacrolimus from one of the most troubled factories in India. Had no idea. 

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.

Cenziper: 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.

Lussenhop: Holy shit!

Cenziper: 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.

Lussenhop: Wow.

Cenziper: 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 DeMayo, like millions of other Americans, will never know the answer to that question. And then Megan will tell you about Hannah. I mean, that one is just, I mean, you know, Joe survived. Joe survived.

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.

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, you know, 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. 

Lussenhop: Wow. 

Rose: 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, um, 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. 

Lussenhop: Oh wow. 

Rose: 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 wanna start over with a new team. Uh, they took her off the ventilator, and she died shortly after. 

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? 

 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 has been left to wonder, you know, if she had just known that information, could she have done something different?

Lussenhop: What was that like to tell her?

Rose: It was really, it was really hard. Um, 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 gonna 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.

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.

BREAK

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. 

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. 

Lussenhop: Megan and Debbie took this question to the FDA. How close had the U.S. 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. 

Rose: 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.

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. 

Rose: And so Debbie and I looked at each other and we’re 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.

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 that 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. 

Cenziper: And what we found was that a small group of midlevel 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.

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

Cenziper: 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, you know, 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.

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 Megan decided they had to talk to her to understand why this policy had been so secretive. 

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

Rose:  And then getting to her house and there’s a security gate! So we, like, literally cannot doorknock her.

Cenziper: So it was a miss. We didn’t know what to do, so we pulled over two blocks away and decided to call her.

Rose: And she picks up. 

REPORTING CALL, Janet Woodcock: Yeah, um, between field and headquarters, there were a lot of tensions all the time. Because the field people really couldn’t understand, like I said, like we saw this problems, like, why aren’t you just completely shutting them down? 

REPORTING CALL, Cenziper: Yes!

REPORTING CALL, Janet Woodcock: They thought that the center was, like, soft on crime.

REPORTING CALL, Cenziper: Mhmm.

REPORTING CALL, Rose: Right…

Rose: Janet was like, OK, let’s talk. Any question. 

REPORTING CALL, Woodcock: That was one of my main roles is, like, deciding things that people were disagreeing about. 

REPORTING CALL, Cenziper: Yeah. Yep. The best part of your job. 

REPORTING CALL, Woodcock: That was my job, that was a lot of my job. Right.

Cenziper: She really said, look, I’ve got nothing to hide. Here’s why we did this. 

REPORTING CALL, Woodcock: You know, it was an approach that we had, let’s put it that way, to, to prevent shortages, you know.

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

REPORTING CALL, Woodcock: People will start scalping drugs. They’ll start getting black market drugs that maybe aren’t even the drug. I mean …

REPORTING CALL, Cenziper: Yeah. 

REPORTING CALL, Rose: Right. 

REPORTING CALL, Woodcock: We’ve seen some really bad things in our time when there’s shortages.

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

REPORTING CALL, Woodcock: The huge, huge majority of, um, drugs on the U.S. market are perfectly fine.

REPORTING CALL, Rose: Right.

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

Cenziper: 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.

REPORTING CALL, Cenziper: Did you do anything extra to track those drugs from, from those particular factories? 

REPORTING CALL, Woodcock: No, I don’t think so.

REPORTING CALL, Cenziper: No, OK.

Cenziper: 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.

REPORTING CALL, Woodcock: We were pretty, you know, confident in the testing that we wouldn’t have, quote, “a really bad drug.” And like I said …

Cenziper: 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.

REPORTING CALL, Cenziper:  Did you tell, did the FDA tell pharmacists and hospitals and doctors, um, to, to keep a lookout? Or did they know about these carve-outs? 

REPORTING CALL, Woodcock: I don’t think so. 

REPORTING CALL, Cenziper: No. 

REPORTING CALL, Woodcock: Uh uh.

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’ve created, quote, “a frenzy.” 

Cenziper: 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 wanna create panic in the pharmacies. And so really, is it information that the public needs to know?

REPORTING CALL, Woodcock: I’m not sure that, that this would do anything for the citizens except cause them anxiety and traipse 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. 

REPORTING CALL, Cenziper: I see. 

REPORTING CALL, Woodcock: But you know, other people feel differently about it. I understand.

Cenziper: 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 wanna be empowered. We all wanna know what we’re putting in our bodies.

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

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. 

Cenziper: 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 wanna be questioned. 

Lussenhop: In a response to ProPublica, a spokesperson for the FDA wrote that the exemptions given to banned factories are “thoroughly evaluated through a multi-disciplinary 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.

U.S. SENATE SPECIAL COMMITTEE ON AGING, Sen. Rick Scott: The U.S. Special — Senate Special Committee on Aging will now come to order. Last year this committee exposed …

Cenziper: Now it seems there’s this bipartisan effort in the Senate to really make changes. And so Sen. Rick Scott and Sen. Kirsten Gillibrand have basically sent letters.

U.S. SENATE SPECIAL COMMITTEE ON AGING, Scott: We sent letters to the Food and Drug Administration, the Department of Veterans Affairs and key industry stakeholders. 

Cenziper: Saying we want there to be more quality testing. We want to know when you’re exempting these drugs.

U.S. SENATE SPECIAL COMMITTEE ON AGING, Scott: It is wholly irresponsible that we are living in the dark when it comes to where our medicines are made.

Cenziper: 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.

U.S. SENATE SPECIAL COMMITTEE ON AGING, Scott: This is why I’m taking action to address these threats immediately with the introduction of my Clear Labels Act.

Cenziper: 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, to these stories. And I think that there might be some real change.

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 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, then he and his entire team built the “Rx Inspector” in just three months. You can try it yourself at propublica.org/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.

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 OK.

Lussenhop: That’s incredible. 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?

Cenziper: The hope, and, and I think this is probably more than hope, it’s fact, is that the, the majority of generic drugs coming into the United States are safe and effective. And so we don’t wanna 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, and that was really why we told these stories, to empower people to make, make good choices.

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’s, 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 we all sort of suffer the consequences of that.

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.

Cenziper: I mean, nobody really knew about this, and shouldn’t we have known?

Lussenhop: Ooh, that gave me chills.

Sabby Robinson: This episode was produced by me, Sabby Robinson. Katherine 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 Berbey. 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/rx-inspector and look up your own pills. Or just search “Rx Inspector.” 

Lussenhop: All right, so let’s give this a whirl! I am going to try to look these pills up using ProPublica’s new tool. OK, 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. Uhhh…