The vast majority of drugs prescribed in the United States, including antidepressants, antibiotics, and sedatives, are generic drugs, many of which are manufactured in overseas factories. While the Food and Drug Administration (FDA) is tasked with enforcing drug safety standards and regulations, a ProPublica investigation found that many drugs still made it to the U.S. despite not meeting those standards.
In this episode, George Headley speaks with Northwestern professor and ProPublica reporter Debbie Cenziper, who, alongside a team of reporters including her students, published a series of stories about the FDA’s oversight of international drug companies. The team spent fourteen months investigating the agency and found that it had allowed more than 150 drugs in the U.S. that should have been deemed too risky for distribution.
Transcript
George Headley: Welcome to “We Mean Business.” This is “Drive to Work with George Headley.” In this series, I talk to people about what drives them to work on highlighting the issues they believe are important. ProPublica recently published a story on the Federal Drug Administration, titled “We Spent a Year Investigating How the FDA Let Risky Drugs Into the U.S. Market,” where they found that the agency has allowed more than 150 drugs in the U.S. through banned factories, mainly in countries such as India. These are primarily generic drugs — a pharmaceutical drug that is cheaper than its brand counterparts. I spoke with Debbie Cenziper, a reporter at ProPublica and a professor at Northwestern University, who has been involved in the investigation since its inception, which was far before ProPublica’s involvement in the project. We spoke about reporting techniques, the origin of the investigation and the obstacles the team faced. The series of stories is still ongoing, and the team is continuing to look for sources as they progress through their reportage. Welcome to “We Mean Business: Drive to Work with George Headley.”
Debbie Cenzipper: I worked with a team of journalists that also included students to work on a series of stories about the Food and Drug Administration’s oversight of generic drug companies. 90% of the prescriptions that we take here in the United States are for generic drugs, that’s everything from sedatives to antidepressants, antibiotics, and many of those drugs come from factories that are overseas, particularly in India and China. And so what we set out to do at ProPublica was understand how the Food and Drug Administration regulates safety practices at factories that are thousands of miles away. What the challenges are, what are the consequences for American consumers when the FDA doesn’t do its job. And so we spent fourteen months looking at this in a series that we published in June in ProPublica. The first part of the series that we published in ProPublica.
Headley: What were the early stages in identifying this issue? I mean, what really got you guys to think as a team, “Okay, this is the problem that we want to pursue”?
Cenziper: There have been problems with generic drugs for years. Back in 2008, a blood thinner, commonly used blood thinner, that came in from China, was tainted with a contaminant that ended up killing and injuring a number of Americans and other people around the world. And since 2008, there have been other drugs that have come in, most recently, eye drops, right like over-the-counter eye drops. And you never think that when you put eye drops in your eyes, that it could hurt you. But in fact, it hurt quite a number of people, because the eye drops were contaminated and they were made overseas. And so we really wanted to take kind of a comprehensive look at how the most influential drug regulator in the world is keeping us safe, by going to overseas factories and trying to figure out if safety standards are being followed.
Headley: And what was the overall thesis that you guys came across, or the biggest hypothesis that you proved?
Cenziper: So what we found, first of all, journalists have been writing about this issue for years, at Bloomberg, there was a best-selling book by Katherine Eban that came out a few years ago. The government watchdog groups have come out with stories, reports about drug safety and the lack of oversight by the FDA, particularly involving foreign factories. What we focused on, and what we found, is that even when the FDA sends inspectors overseas to spend days at a time in factories to be sure that they’re being safe and that they’re they’re producing quality medications, that those factories are often given a pass by the agency, meaning that the FDA will say your drugs are so suspicious that we’re going to ban your factory from shipping drugs here until you fix these problems. And so the FDA does that regularly, but then in some cases, they’ve given certain factories a pass. They’ve banned them from the U.S. market, but then excused certain drugs that they make, allowing those banned factories to continue to ship potentially unsafe drugs to Americans. And the FDA says they’ve done it to prevent drug shortages, which is a very fair, fair thing to say. However, they were letting these drugs in year after year. Our reporting found more than 150 drugs are key ingredients over the past 12 years, without actively testing them to see if they were safe, and without monitoring reports of harm to see if there were patterns of harm, to see if people had been hurt and if so, how many. And so they were giving out these passes, making concessions to some big drug makers that had some pretty serious problems, without doing the work on the back end to be sure that the drugs they were letting into the U.S. were actually safe for all of us.
Headley: What were the reporting techniques that you taught your students during this investigation, because I’m sure as a professor, you learned to mold with what your students are learning as they go about the investigation. What were the bigger reporting techniques that you had to teach them during this to better the story overall?
Cenziper: So I’ve been working with student journalists for years at Northwestern, and before that elsewhere, and I always love to say that student journalists, particularly investigative journalists, bring fresh eyes and really smart ideas to the table. I love working with young journalists for that reason, and so we started just trying to figure out how often people may have been harmed by drugs. We didn’t even know what we were going to look at when we first started. We just knew we wanted to look at drug safety. So what has happened over the years? Who are the manufacturers that we should be concerned about? How often does the FDA go overseas? So my students were able to look at lawsuits. They were able to look and read inspection reports written by the FDA. They did a lot of the groundwork. And then over fourteen months, we started building a team at ProPublica, and so we all started collaborating to try to figure out what works and what doesn’t and why things are the way they are.
Headley: What was, in your opinion, the most interesting or creative tool that you and your team used at ProPublica for this investigation?
Cenziper: Well, one of the things we learned early on is that the FDA was giving out these passes that I just described to some of the more troubled drug makers, mostly in India, one in China, one in Hungary. And they were giving out these passes, letting them send potentially dangerous drugs into the United States, and they weren’t testing, they weren’t looking for harm, but the FDA really never told the public that this was happening. In fact, they didn’t even really tell Congress that this was happening. There was this very secretive group inside the FDA that made this decision, and in fact, even their colleagues inside the agency didn’t know about this practice. So the first hurdle we had was just figuring out how often this happened. We had no idea. We asked the FDA for a list. They said they didn’t keep a list, which I was just floored by, because I thought, “How do you not know how often you’re giving out these passes?” And so what we did is we worked with some very smart data people at ProPublica and my students, and we were able to use something as simple as the Wayback Machine on the internet, right, to find archived reports that the FDA had put out. And then we just started counting them up by hand. And then one of our brilliant data team members at ProPublica was able to leverage AI to see, could we have missed anything, and what did we miss? And so between hand-counting. right, good old-fashioned, old-school journalism and AI, the new frontier in investigative reporting, we were able to pull together, potentially the first ever list of these exemptions.
Headley: What was the biggest challenge that your team faced during this investigation for its first year?
Cenziper: Well, we faced a number of challenges. And you know, any journalist will know and will commiserate with this, we filed probably two dozen plus Freedom of Information Act requests trying to get information from the FDA. The typical turnaround time is 24 months. That’s two years. And so ProPublica filed a FOIA lawsuit against the FDA to try to get them to release records in a reasonable timeframe. After all, we’re writing about the safety of the American public. So there was, we felt, a compelling need to release records quickly, so we filed a lawsuit. It’s, in fact, the second lawsuit that ProPublica has filed in the last few years for projects that I’ve worked on involving the FDA. So we were able to really shake the trees there and get some records, and we’re still getting those records early on, but one of our greatest challenges is that the FDA keeps secret the names of the drugs that are made at troubled factories. So even when the FDA releases an inspection report, makes an inspection report public, they’ll redact the names of the drugs that are made in those factories. So even if you are a consumer and you run to your medicine cabinet. And you think, “I want to know if I’ve got a problem here.” And you, by chance, find this inspection report, you won’t know because they redact the names of drugs. So we had to develop all kinds of workarounds to kind of get behind that secrecy issue.
Headley: When you look at certain investigations, at least for investigative journalists, you always wait till, at least, in my opinion, you wait till there’s a complete, finished project and you publish it all because you could be afraid that some other news outlets will potentially poach your work, right? And what I find interesting here is that you guys are still reporting on this topic, and you’re asking for certain experts or people within the fields to just reach out. What are the benefits or consequences of letting it go public, that you guys are really investigating into this?
Cenziper: That’s a great question. And investigative journalists are always looking over their shoulders. We’re suspicious people by nature, and we always worry about that. But back in the day, when I first started doing this, we reported everything we could in a year, and then we did a four-part series, one day, two day, three days, four. It was just kind of hitting our readers over the head with everything that we found. I had a very smart editor at the Washington Post talk about the benefits of a rolling investigation, right? I mean, we don’t want to hold back. We want people to know what we find, and in publishing, yes, we risk a competitor trying to get in this space, but it’s a pretty significant space, and there’s plenty to write about. And by telling readers what we have now, it also shakes the trees. We can develop sources. People write to us, people write in, and so, we’ve heard from a couple of whistleblowers since we first published last month, and we’re running on new stories now based on what they told us. So there are benefits to a rolling investigation. It allows journalists to put out our findings faster, and in this case, we saw that as a public service.
Headley: What advice would you give to either student journalists or journalists starting out that would want to enter the field of investigating the FDA? I know you’ve had extensive experience working, you know, reporting on this agency. What advice would you give journalists who are just starting out there, thinking, “Okay, I want to tackle, you know, the healthcare industry,” for example?
Cenzipper: There are too many stories to name in this space. Think about what the FDA regulates. They regulate products. The agency regulates products that affect every single person in this country, from baby food to tobacco products to drugs to food to medical devices to cosmetics. They are a pretty, a significant force, and there have been problems there for years. There’s also a ton of good people that go into government and that go into government for the right reasons, and that try to do the right thing, but too often, unfortunately, things don’t work right, or they make promises and they fail to deliver. And so there is plenty of stories to be done, and what I would advise young journalists or anybody new on this topic or new on this beat, is to spend some time just getting to understand it. One thing we do as investigative reporters so often is we jump from topic to topic. So three years ago, I was writing about one thing, and now I’m writing about something entirely different, and we basically have to become an expert as quickly as we can on a new topic. It’s like climbing a mountain, right? And in the beginning, what I always say is, my sources know so much more than I do. Obviously, they’re the experts, and I’m like sucking wind trying to – am I ever going to get there? Am I ever going to understand the data, the terminology, the nuances? Am I ever going to get there? And by the time I’m ready to publish, I know that I’m ready to publish, because I feel like I know a little bit more than even some of my sources based on the work that I’ve done. But you’ve got to give yourself the time to climb that mountain and to really understand it, and that’s a hard thing to do in today’s newsrooms, right? Because we’re always trying to feed the beast and write quickly and, you know, get clicks and all of the stuff that we face. But as investigative reporters, we’ve got to find the time to understand what it is that we’re writing about, and this is one big agency, so it takes a little bit of time.
Headley: When you approach this investigation, did you look at it from the lens of health journalism or from the lens of business journalism in regards to how the market functions regarding risky drugs?
Cenzipper: I would say a little bit of both. I’ve been an investigative journalist for a very long time, 30-plus years, and I can tell you that what I’ve learned over time is that we expect for-profit companies to want to make money, to cut corners sometimes, to not necessarily think about who’s affected by what they’re doing. You expect companies that are global, that bring in billions of dollars in revenue, to sometimes not do the right thing, but we expect our regulators to be there as a safety net. We expect that. And so to me, the angle, it’s not enough to say “this is a bad company doing bad things.” To me, the higher bar, as an investigative reporter, is to say “and the government wasn’t there to stop it.” And so I really looked at this in some ways, a government story more than a business story. Now, other incredible reporters have written similar things from a business perspective, right? Supply, demand, the way insurance companies work, all of the nuances that contribute to what we deal with today in terms of getting drugs. I really wanted to look at it from the perspective of, what is the government doing or not doing to prevent the problems that we see?
Headley: That was Debbie Cenzipper, a reporter at ProPublica and a professor at Northwestern University, and this is “We Mean Business: Drive to Work with George Headley.”
