Bottle of Lies: How Poor FDA Oversight & Fraud in Generic Drug Industry Threaten Patients’ Health

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Generic drugs amount to 90% of all prescriptions filled in the U.S., most of them made in plants in India and China. Generic drugs can be more affordable, but in her new explosive book “Bottle of Lies: The Inside Story of the Generic Drug Boom,” investigative journalist Katherine Eban works with two industry whistleblowers to expose how some manufacturers are cutting corners at the cost of quality and safety. This comes as the U.S. Food and Drug Administration just issued its own update on the state of pharmaceutical quality that found the drug quality of factories in India and China scored below the world average. FDA officials say that’s because more robust inspections have uncovered problems and that “the quality of the drug supply has never been higher.”

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This is a rush transcript. Copy may not be in its final form.

AMY GOODMAN: We begin today’s show looking at an explosive new investigation that exposes widespread unsafe conditions in many Indian and Chinese factories that manufacture generic drugs that comprise nearly 90% of the pharmaceutical drug supply in the United States. Nearly 80% of the active ingredients of all drugs, brand or generic, as well as almost all antibiotics, are made outside of the United States. Generic drugs are, of course, cheaper than brand-name drugs. But in her new book, Bottle of Lies: The Inside Story of the Generic Drug Boom, journalist Katherine Eban works with two industry whistleblowers to expose how many overseas manufacturers are cutting corners at the cost of quality and safety.

This comes as the U.S. Food and Drug Administration just issued its own update on the state of pharmaceutical quality that found the drug quality of factories in India and China scored below the world average. FDA officials say that’s because more robust inspections have uncovered problems. Two factories in China and India were linked to recalls of the commonly prescribed blood pressure drugs losartan and valsartan, after testing revealed the drugs were tainted with possible carcinogens. The report prompted the FDA’s director of drug evaluation and research to conclude, quote, “the quality of the drug supply has never been higher.”

So, can generic drugs be trusted? For more, we spend the hour with Katherine Eban to discuss this explosive book, Bottle of Lies. She is the author of a previous book on the pharmaceutical industry titled Dangerous Doses: A True Story of Cops, Counterfeiters, and the Contamination of America’s Drug Supply. She’s a contributor to Fortune magazine, was previously staff writer for The New York Times and New York Observer.

Welcome back to Democracy Now! It’s great to have you with us, Katherine.

KATHERINE EBAN: Thank you. So nice to be here.

AMY GOODMAN: So, this is life-and-death information. Start off by talking about what exactly generic drugs are.

KATHERINE EBAN: So, generic drugs are a version of the brand-name drug. They’re not an identical copy, but generic companies reverse-engineer—they break down—the brand-name drug and figure out how to remake it. They have to use the same molecule. They have to use the same route of administration, whether it’s swallowing a pill, injecting. And then they have to submit an application to the U.S. Food and Drug Administration. And the FDA reviews data to see whether those drugs are bioequivalent. Do they reach the same peak concentration of drug in the blood? And if the FDA deems that they do, they are approved to make a generic version.

AMY GOODMAN: And explain—what is the breakdown of what Americans take? And also, of course, the insurance industry and what it will cover, which determines what we all imbibe?

KATHERINE EBAN: Right. So, 90% of our drug supply is generic. The majority of those drugs come from overseas. Forty percent alone of all of our generics are manufactured in India. And if you go to a pharmacy, you will automatically be switched to a generic drug if one is available. What’s interesting to me is, even though the name of the manufacturer will be on the label, consumers will not have information about where those drugs are manufactured.

AMY GOODMAN: Why? Did they ever?

KATHERINE EBAN: I’m not sure that they ever did, but the companies claim it’s proprietary. So, for the U.S. consumer, they’re getting less information about where their drugs are made than where their cereal is made, where their shirt is manufactured. That information is simply not available, and you have to be, unfortunately, an investigative journalist to figure out where those drugs are manufactured.

AMY GOODMAN: I bet a lot of people are shaking their heads right now, and they’re going, “I knew, when I switched to a generic, that I felt differently.” Now, what about those who would say, “What? Are you just working for the generic drug companies, and you’re promoting these way more expensive brand drugs?”

KATHERINE EBAN: Right. Well, this is an issue for brand companies and generic alike, because 80% of the ingredients in all our drugs, whether brand or generic, are being manufactured overseas. So, this is really a quality issue that is affecting brand and generic companies. And, you know, I should hasten to add, I’m an independent investigative journalist. I have received absolutely no money from any manufacturing concerns, which is a statement that is disclosed in my book.

AMY GOODMAN: So, also explain what “active ingredients” means.

KATHERINE EBAN: Right.

AMY GOODMAN: Again, nearly 80% of all active ingredients in all drugs, brand or generic—

KATHERINE EBAN: Right.

AMY GOODMAN: —are made outside the United States. And almost all antibiotics are made outside the United States.

KATHERINE EBAN: Right. So, active ingredient is the key ingredient in the drug. It is the sort of synthesized molecule that makes the drug effective. It’s the central—the central element of the drug that has the effect on the person. So, if active ingredient—what’s common, an active ingredient will be manufactured in China. It will be shipped to India. An Indian manufacturer will make the finished dose, and then it will arrive at our pharmacy. And, of course, that is invisible to the consumer.

AMY GOODMAN: So, why did you decide to write Bottle of Lies? What prompted you?

KATHERINE EBAN: It started in 2008, so a decade ago. And I was contacted by an NPR radio show host, Joe Graedon. He runs a show called The People’s Pharmacy. He was concerned because patients were writing in to his show, calling in, and saying that they had symptoms—in some cases devastating symptoms—after being switched to certain generics. And those complaints greatly concerned Joe Graedon, because there was a lot of commonality between them. A lot of patients were complaining about similar or the same drugs. They were complaining about time-released drugs. So, those are slightly more complex. Some of them were suicidal after being switched to antidepressants. Some of them were having seizures after taking epilepsy drugs. And he had been sending these complaints to the FDA, and basically the response he got back was that everything is fine. So, he really felt that somebody with, as he told me—and I saved my notes from that call—he wanted somebody with investigative firepower to look into them.

AMY GOODMAN: I was just talking to a New York Times reporter last night whose sister has epilepsy but didn’t suffer from seizures for years. She took Dilantin. That’s the brand name. But then she had to switch to the generic. It’s all the insurance company would cover.

KATHERINE EBAN: Right.

AMY GOODMAN: And she immediately started to seize.

KATHERINE EBAN: Right.

AMY GOODMAN: But she was not allowed to go back on Dilantin; at least the insurance company wouldn’t cover it. And he was describing to me about his sister that even when she went into the pharmacy and had her doctor’s prescription for Dilantin, the pharmacy would not fill it and would not allow her to actually pay for it.

KATHERINE EBAN: You know, there’s a real disconnect here. If you decide that you don’t want to eat factory-farmed meat, you as a consumer can go into a supermarket and buy organic, grass-fed meat from a small family farm. But if you decide that you don’t want to buy a foreign-manufactured generic or you want to have a brand instead of a generic, a consumer has really no control or power in this equation, which is one of the reasons why this has been sort of so concealed behind layers of insurance companies and middlemen.

AMY GOODMAN: Yet the FDA says a generic medicine is the same as a brand-name medicine in dosage, safety and quality.

KATHERINE EBAN: Right. And on paper, that is true. On paper, that is the FDA’s standard. And they will point to that standard. But what I set out to find out: What is actually going on in these distant manufacturing plants where our drugs are made?

AMY GOODMAN: We’re going to break, and then we’re going to come back to this discussion.

KATHERINE EBAN: OK.

AMY GOODMAN: I mean, you are a clear investigative journalist on the trail. You worked with whistleblowers, that are astounding, as they go abroad to try to find out how—what kind of conditions these drugs are made in that are the supply for a large sector of the United States. Katherine Eban is author of Bottle of Lies—the book has just come out—The Inside Story of the Generic Drug Boom. This is Democracy Now! We’ll be back with her in a minute.

[break]

AMY GOODMAN: “Things You Can Do,” instrumental by Deltron 3030. This is Democracy Now! I’m Amy Goodman. We’re spending the hour with investigative journalist Katherine Eban. She’s author of the explosive new book Bottle of Lies: The Inside Story of the Generic Drug Boom. It’s just been published. So, take us on a journey with Peter Baker. Tell us who he is.

KATHERINE EBAN: So, Peter Baker was a 32-year-old FDA investigator. They were called consumer safety officers. And in 2012, the FDA looked around and asked: Would any of its investigators like to relocate overseas to their poorly staffed, remote offices in India or China to investigate the drug plants making our generic drugs? And Peter Baker is a motorcycle-riding, tattooed tough guy who was up for an adventure. But he had another reason that he wanted to volunteer, which was that, by reputation, Indian manufacturers were market leaders in aseptic manufacturing, which is the very demanding manufacturing of making sterile drugs. So he volunteered to relocate, and wound up in New Delhi.

AMY GOODMAN: And explain what he found.

KATHERINE EBAN: So he started investigating these plants. And he had a different way of investigating than a lot of FDA investigators. He skipped the guided tours and the opening slideshows, and he went right to the quality control labs.

AMY GOODMAN: Wait, wait, wait. Are these tours announced in advance?

KATHERINE EBAN: That is one of the big problems. The FDA announces its inspections overseas in advance, sometimes giving two months’ advance notice to plants that they are coming.

AMY GOODMAN: So what does that mean? What can they do in that amount of time?

KATHERINE EBAN: They can do a lot. I mean, as one investigator said, “Give them a weekend, they can put up a building.” But, basically, the accusation is that these plants overseas are staging their inspections. And one of the remarkable findings in my book is that they literally have data fabrication teams that come in, in advance of these inspections, shred documents, fabricate documents, invent quality data, invent standard operating procedures, all in advance of the FDA’s arrival.

AMY GOODMAN: So, he goes into a factory.

KATHERINE EBAN: Yeah. One of the first plants that he went into was a company called Wockhardt, and this was a sterile manufacturing plant where the quality controls are incredibly strict, down to employees having to move very deliberately and slowly so as not to disturb the airflow in the plant. It’s that strict and regulated. And it was his second day of the inspection. He was in a hallway, and he saw an employee at the other end of this long, brightly lit hallway with a clear garbage bag, and the man was walking in a furtive manner. And as soon as the employee saw Peter Baker and his colleague, a microbiologist, he turned around and started walking the other way again. And the microbiologist yelled “Stop!” The man broke into a run. He tossed the garbage bag under a stairwell. And Peter Baker opened the garbage bag and found 75 torn batch records which indicated that insulin the company was manufacturing was contaminated with metallic particles but nonetheless had been released to patients in India and the Middle East.

So, Peter Baker is only responsible for U.S. medications, but he followed the trail of these documents. He went to this area of the plant, which had not been disclosed to the FDA, and he found the plant was manufacturing a sterile injectable cardiac drug on the same equipment that had created the metallic particles. So, he basically exposed deep fraud in this plant.

AMY GOODMAN: And so, what happens then? And I kept talking about the number of Americans who take these drugs, but, I mean, these drugs go out to the world.

KATHERINE EBAN: Absolutely. And actually, as a separate part of my investigation, which is also in the book, the plants make differing levels of quality for different markets. So, basically, their manufacturing standard can be whatever they can get away with. In other words, if they’re sending to other parts of the world, they lower their quality, they lower their quality ingredients, they skip manufacturing steps.

AMY GOODMAN: So, what happens when you find this contamination, when an inspector finds this contamination?

KATHERINE EBAN: Well, in this case, because Peter Baker discovered this, the plant was hit with a massive set of observations, in a form called a 483. They were put on import alert, which means their drugs were restricted from coming into the U.S. market. And so, in that instance, the inspection system worked as it should.

AMY GOODMAN: Can you talk about Ranbaxy?

KATHERINE EBAN: Yeah. So, Ranbaxy was India’s largest drug company and the largest maker of generic drugs and the fastest-growing generic drug maker in the U.S. And in 2005, a young information architect named Dinesh Thakur left Bristol-Myers Squibb and took a job at Ranbaxy. So he moved his family to Gurgaon. And—

AMY GOODMAN: To India.

KATHERINE EBAN: To India. And at a certain moment, his boss, who had also come from the brand pharma sector in England, got concerned about the quality of the data at Ranbaxy and had had some evidence that there was fraudulent data in some of the company’s HIV drugs. And so he gave Thakur an assignment, which was to investigate all of the company’s regulatory filings around the world and get to the bottom of whether there was actually data that existed for all of the claims that the company had made to regulators.

AMY GOODMAN: I want to go back to Peter Baker and what happened to him. So, he exposes this contamination at a major plant in India that’s making heart drugs, among others.

KATHERINE EBAN: In the course of five years, he inspected 86 plants in India and China, and he found some aspect of data fraud or deception at 67 of those plants, really almost four-fifths of the plants that he inspected. And he—

AMY GOODMAN: Repeat that. He found?

KATHERINE EBAN: He found some element of data fraud or data deception in almost four-fifths of the plants that he inspected overseas in India and China. And he did it with a completely different inspection method. Instead of looking at the records that the plant was giving him, he went into the manufacturing plant’s computer systems, and he started looking at deleted audit trails. And he tracked the metadata in the computer systems and realized that in many of these plants they were conducting what are called pretests. They were doing an initial offline screen of the drugs to see what the quality was, and then potentially making alterations to the tests, so that when they retested the drugs in the official system of the plant, they would pass quality tests.

AMY GOODMAN: And what happened to Peter Baker?

KATHERINE EBAN: He left the agency in March. Based on the experiences he had in India—he was followed, he was threatened. In one instance, he was poisoned with tainted water at a plant. Some of the investigators that he worked with were spied on. A hotel room was bugged. And based on this sort of aggregate experience, he was actually diagnosed with post-traumatic stress.

AMY GOODMAN: And the perks that inspectors get? I mean, what you described is hardly a perk—poisoned water. But what about how they’re treated? And how important are these companies to the countries, India and China?

KATHERINE EBAN: Well, one of the huge problems, as we discussed, is that the inspections by the FDA are announced two months in advance. And remarkably, the FDA even turns to these plants to arrange local travel, to arrange hotel ground transportation. And so, what happens is that the inspectors arrive. They’re picked up at the airport in a luxury car. They’re taken to a hotel, where their rooms are magically upgraded, and they never see a bill. There are trips to the Taj Mahal, shopping trips, massages, golf outings—a system that, as one of my sources called it, regulatory tourism. And the problem is, when the FDA says our drug supply has never been safer, they are discounting the fact that the findings of the plants are in this system of preannounced inspections.

AMY GOODMAN: And going back to Ranbaxy, this was the largest drug company in India.

KATHERINE EBAN: Yeah.

AMY GOODMAN: Explain what happened to it. And also talk about Lipitor.

KATHERINE EBAN: Yeah. So, Dinesh Thakur, who became a whistleblower, began doing—

AMY GOODMAN: Who worked at Bristol in the United States.

KATHERINE EBAN: That’s right.

AMY GOODMAN: Bristol Squibb, and then was recruited to go to India.

KATHERINE EBAN: That’s right. Once he started this research project, which was to investigate the company’s worldwide regulatory filings, he discovered that more than 40 products in over 200 countries—excuse me, more than 200 products in over 40 countries were filed with data that did not exist, falsified data in which the company was literally taking the brand drug and running tests off the brand drug and submitting it as its own data. I mean wild fabrications.

AMY GOODMAN: So, wait. They would use the brand drug, but in fact they would put the results to the generic they were making.

KATHERINE EBAN: That’s right. And this is—you know, this kind of fraudulent data is what they were using to get approval from the U.S. FDA. So, Dinesh Thakur, once this got exposed, his boss went into a board meeting and presented this to a subcommittee of the board of directors. And the question that he got back is: Could the report be buried, and could the laptop that the report was created on be destroyed? So, the company chose to conceal this. Ultimately, his boss resigned, and he was forced out of the company. And he decided to approach regulators with the information that he had, and ultimately he became a whistleblower for the FDA.

AMY GOODMAN: What happened to the drug company, Ranbaxy?

KATHERINE EBAN: Well, they—not only did they continue manufacturing and selling drugs for more than eight years from Dinesh Thakur’s first approach, the FDA, in the middle of what was a criminal investigation of this company for fraud, greenlighted Ranbaxy to manufacture the biggest generic drug in U.S. history, the first generic version of Lipitor.

AMY GOODMAN: And explain what Lipitor is used for.

KATHERINE EBAN: So, Lipitor is a cholesterol-reducing drug, which millions and millions of Americans take. So, it’s called a [statin]. And it is the biggest-selling drug of all time. And one year after Ranbaxy was given the green light to manufacture this, they made about $600 million in six months. Millions of their doses of Lipitor had to be recalled because they were infused with glass fragments.

AMY GOODMAN: And that’s just what we know. They happened to find this.

KATHERINE EBAN: They were under such scrutiny by the FDA that they ended up disclosing the glass fragments to the FDA, yeah.

AMY GOODMAN: What can—

KATHERINE EBAN: And they had to be recalled.

AMY GOODMAN: What can an individual do? I mean, what do you do if you’re taking the generic form of Lipitor and you feel sick, you feel different from when you took Lipitor?

KATHERINE EBAN: Right. So, you know, there is so little disclosure to consumers. I mean, one thing that every consumer can do is, they have a maintenance drug, and they feel it’s working—

AMY GOODMAN: Explain what you mean by “maintenance drug.”

KATHERINE EBAN: If they have a drug that they take every month, day in and day out—and many Americans do. Let’s say they are dispensed a drug that makes them feel good, that seems to be effective, that has minimal side effects.

AMY GOODMAN: So you’re taking it every day, like for thyroid—

KATHERINE EBAN: That’s right.

AMY GOODMAN: —for heart—

KATHERINE EBAN: Right.

AMY GOODMAN: —for cholesterol.

KATHERINE EBAN: Right. What they need to do is look at the manufacturer on the label, OK? They feel pretty good. We are all getting switched from generic to generic to generic every time we go to a pharmacy. But once you know that there is a manufacturer that is working for you, you need to inform your pharmacy that is the drug you want to continue taking.

The other thing consumers should do, which I do when I’m dispensed a drug and there’s a manufacturer name, I go to Google, and I put in ”FDA warning letter” and the name of that manufacturer, in order to see what have the FDA’s findings been about that drug and about that manufacturer.

AMY GOODMAN: So, you have to do the research yourself. Would you take a generic drug? And also, I mean, how it compares to how these brand drugs are made and where they’re made, in the same places?

KATHERINE EBAN: Right, right. Well, I do take generic drugs. Of course, we all take generic drugs. Because I know the history of a lot of these manufacturers, there are companies whose drugs I don’t take and companies whose drugs I will take.

AMY GOODMAN: When we come back, we’re going to talk about how these drugs are dumped on Africa.

KATHERINE EBAN: Yes, absolutely.

AMY GOODMAN: I want to also talk about the story of Cipla—

KATHERINE EBAN: Yes.

AMY GOODMAN: —and the significance of this. We’re talking to Katherine Eban, who is investigative journalist. Her book is just out. It’s an explosive book. It’s called Bottle of Lies: The Inside Story of the Generic Drug Boom. This is Democracy Now! Back with her in a minute.

[break]

AMY GOODMAN: “It’s Been Awhile” by Staind, here on Democracy Now! I’m Amy Goodman. We’re spending the hour with investigative journalist Katherine Eban, author of Bottle of Lies: The Inside Story of the Generic Drug Boom. It’s just been published. I want to turn to the Indian scientist Yusuf Hamied, chair of the drug manufacturer Cipla, who shook the conscience of the global health community by offering to produce generic AIDS medication at a tiny fraction of the cost. This is Dr. Hamied speaking several years ago.

YUSUF HAMIED: You must understand that today in the world there are about 40 million HIV-positive. You must also understand that 8,000-plus are dying every day because of HIV and related illnesses. The problem is not just what Cipla can do. It’s a much wider problem. We’re a small company; we’re not a major company. So I sincerely believe that the effort required is a team effort—the multinational companies, ourselves, the government, or governments of various countries. And it has to be a team effort.

AMY GOODMAN: That’s Dr. Yusuf Hamied, Indian scientist. We’re spending the hour with journalist Katherine Eban, author of Bottle of Lies. Talk about Hamied, talk about Cipla, and what he did.

KATHERINE EBAN: Yeah. First, let me just correct myself, which is, Lipitor, of course, is a statin, not a sartan. We were talking about valsartan earlier, so I misspoke.

But Dr. Yusuf Hamied is really one of the great individuals of the 21st century. He looked around, saw this massive AIDS epidemic, and he saw brand companies protecting their drugs through a minefield of patents, and decided something had to be done. And so what he did was he announced, working with a group of activists, that he was prepared to manufacture AIDS drugs for a dollar a day, which was such a dramatic price cut that that set in motion a series of events that led to, ultimately, a very important U.S. program called PEPFAR, in which U.S. taxpayers—

AMY GOODMAN: This was a George W. Bush program.

KATHERINE EBAN: It was under George W. Bush. It was—President Clinton had a big impact on the events that led to it, because the Clinton Foundation helped, working with Indian manufacturers, to reduce the price further to 38 cents a day. He sort of aggregated the buying power of African governments and U.S. taxpayers and sort of, through this groundbreaking coalition, was able to get U.S. taxpayers to buy in bulk AIDS drugs for Africa as a way to tackle the AIDS epidemic.

AMY GOODMAN: What was the response of the global pharmaceutical community?

KATHERINE EBAN: Well, at first, the global pharmaceutical community was actually dead set against this. They were—wanted to protect their patents. And the outcry was so enormous that, ultimately, they waived their patents so that the India manufacturers could make these AIDS cocktails at a very low price.

AMY GOODMAN: I want to go to a tweet you posted about an executive from the Indian-based company Ranbaxy, the largest pharmaceutical company—

KATHERINE EBAN: Yeah.

AMY GOODMAN: —in India, that was. You wrote, “More telling was a shocking disregard for human life, from some company executives. When discussing the poor quality of the company’s AIDS drugs for Africa, on a conference call, a Ranbaxy medical director said: 'Who cares? It's just blacks dying.’”

KATHERINE EBAN: It’s a very disturbing statement. And this was said out loud on a conference call of Ranbaxy executives in about 2004. But it reflected a larger problem in the generic drug industry, which is, a lot of these companies have what’s called dual-track or multitiered production, which is they make their better drugs for more regulated markets, like the U.S. and the EU, and they will make worse-quality drugs for developing markets or markets that they call ”ROW,” which is “rest of world.”

AMY GOODMAN:ROW” means “rest of world.”

KATHERINE EBAN: Correct, yes. So those are developing markets where they have made a calculation that because regulation is so poor, they’re not going to get caught.

AMY GOODMAN: So, when someone travels—another example is, when someone travels overseas, they say, “You can’t believe how cheap I can get drugs there, the very same drugs we get in the United States.”

KATHERINE EBAN: Right, right. But they’re of worse—

AMY GOODMAN: That’s not true.

KATHERINE EBAN: —quality. And I shake my head. Even when I was reporting my book, and I traveled to India, and I had friends say, “Can you bring me back some antibiotics?” And I said, “Do you understand what I’m reporting? Why would I do that to you?”

AMY GOODMAN: So, you tweeted about your smoking gun around Ranbaxy.

KATHERINE EBAN: Yeah.

AMY GOODMAN: Talk about the documents you found.

KATHERINE EBAN: Right. So, the smoking gun was this PowerPoint presentation which was shown to a subcommittee of the board of directors. And it spelled out, in detail, that Ranbaxy had fabricated data, completely invented data, for more than 200 products in more than 40 countries, in an effort to just support business needs. In other words, they needed approvals, and they made up data. Inside the company, this document or presentation came to be known as the SAR, which was short for “self-assessment report.” And it really shaped the behavior of a number of the company’s top executives in an effort to suppress this document.

AMY GOODMAN: And again, say what Ranbaxy made and what happened to it.

KATHERINE EBAN: Yeah. So, I mean, Ranbaxy was manufacturing a huge number of generic drugs for the U.S. market. They were manufacturing generic drugs all over the world. Ultimately, this document, the disclosures around this document and prosecution by the U.S. government, not to mention Dinesh Thakur’s heroic efforts, brought down the company.

AMY GOODMAN: Why aren’t drugs, the active ingredients, generics, the brand drugs, antibiotics—why aren’t they made in the United States for U.S. citizens and noncitizens?

KATHERINE EBAN: Right. So, this has been part of a sort of long exodus of manufacturing from the U.S. market. It really started with antibiotics. One of the issues was environmental regulations, and companies wanted to—you know, very stringent or more stringent environmental regulations in the U.S. So, there’s a lot of waste production in manufacturing of antibiotics and drugs generally, so they shifted manufacturing overseas, to China and to India, and a lot of the manufacturing of other drugs followed. And, in fact, the brand-name companies also ended up shifting manufacturing overseas. They bought up manufacturing plants and found that, you know, almost overnight, they could cut some of their costs, by about 80%—the cost of labor, the cost of ingredients. So that was really one of the reasons behind it.

AMY GOODMAN: Could the government produce these drugs?

KATHERINE EBAN: Absolutely. And Elizabeth Warren, in fact, has a very interesting proposal to get the U.S. government to manufacture essential generic drugs. I mean, looked at one way, this is a national security issue. We need to manufacture our own medicine. What if we pissed off India, and they said, “Sorry, no more antibiotics”? We’d really be in a fix.

AMY GOODMAN: Some of the people you spoke to said they avoid taking prescription drugs.

KATHERINE EBAN: Well, they were more specific than that. And, in fact, this was a number of FDA investigators, who, based on the things that they witnessed in these plants overseas, basically have stopped taking generics manufactured overseas.

AMY GOODMAN: Where do they get them then?

KATHERINE EBAN: They try not to get sick. They are very particular about which companies they take drugs from. And it’s based on their own knowledge.

AMY GOODMAN: Are there lists of records? If you’re not an insider FDA inspector, where can you go online to see what companies am I going to get drugs from? And then, if you can go more specifically, and even if I’m going to get a drug from a company, I don’t want it made at this plant or that plant.

KATHERINE EBAN: Right.

AMY GOODMAN: Is there any way to find this out?

KATHERINE EBAN: I have been talking to people about trying to put together forward-facing data for consumers. You know, I don’t have any announcements to make right now on that front, but my hope is that there will be some forward-facing data available for consumers. Unfortunately, right now it’s all just in one bucket over here and one bucket over there. You know, consumers who get really interested in this can look on the FDA’s website for warning letters. Yeah.

AMY GOODMAN: What’s happened at the FDA? President Trump prides himself on rolling back regulations in the regulatory agencies, the FDA chief among them.

KATHERINE EBAN: Well, one of the things that’s been going on, which really needs further investigation, is that the FDA has been, almost systematically, downgrading the findings of its own investigators in these overseas generic plants. Now, they just put out a report saying that the quality is very high, and everything is fine, and they’ve got this under control. But, in fact, behind the scenes, they are downgrading from the most serious findings to less serious findings. And, you know, the documentation that I was able to get shows they’re making these decisions for political reasons. They’re making them because drafts of warning letters sat on their desks for too long. And this is something that really needs to be, I think, investigated by Congress.

AMY GOODMAN: In the wake of your book, public health advocate and whistleblower Dinesh Thakur, as well as Erin Fox, senior director of Drug Information and Support Services, University of Utah Health Care, have called on Congress and the FDA to hold hearings on generic drug safety.

KATHERINE EBAN: Yeah.

AMY GOODMAN: Do you see that happening anytime soon?

KATHERINE EBAN: I’d like to think that it would. I hope it would. You know, it’s very hard to say what, if anything, is going to happen in this political environment.

AMY GOODMAN: Have any lawmakers responded? And how much in the pocket are lawmakers, Democrat and Republican, of the drug industry?

KATHERINE EBAN: Certainly, there is a lot of lobbying—we all know that—by the pharmaceutical companies. I think that lawmakers who have been on this a long time are inclined to look at the role of the FDA in all of this and their claims that their regulation is adequate. I think there is some appetite to do that.

AMY GOODMAN: So, you’ve been working on this book for years, and you’ve been doing this kind of research way beyond the research you did for this book. What shocked you most, Katherine?

KATHERINE EBAN: Some of the falsifications and fabrications that are going on in these plants. For example, they’re even fabricating their own data proving that the plants are sterile. They’re falsifying their microbiology data. They have to test the environment. They have to test the air. They have to test the water. They’re fabricating that data. So, what is real, and what is fake?

AMY GOODMAN: Is there a particular story that sticks in your mind that you cannot shake?

KATHERINE EBAN: I mean, I would have to say Peter Baker’s investigations into the plant, Wockhardt, which I chronicle in my book.

AMY GOODMAN: Peter Baker, the FDA inspector.

KATHERINE EBAN: Yes, absolutely. I mean, from the moment that he lands at an airport, is followed by company representatives, one of whom—there is a man who yanks open the door of his cab, takes a hard look at him, closes it again. The investigators go to the plant. Several of them fall ill because of tainted water. They learn later that even as they were at night in the hotel room talking about their inspections and their findings, the company had bugged the hotel room. That is the level of the—

AMY GOODMAN: And how much support did he get from the FDA?

KATHERINE EBAN: Minimal, absolutely minimal. In fact, they pulled him off of doing inspections. I mean, he’s one of the most—he’s sort of the Pablo Picasso of FDA investigations.

AMY GOODMAN: And he left just now, just this past March.

KATHERINE EBAN: Yes. That’s right.

AMY GOODMAN: Under the Trump FDA.

KATHERINE EBAN: Yeah.

AMY GOODMAN: I want to thank you for being with us.

KATHERINE EBAN: Thank you.

AMY GOODMAN: We’re going to do Part 2 and post it online at democracynow.org. Investigative journalist Katherine Eban is the author of Bottle of Lies: The Inside Story of the Generic Drug Boom. It’s just been published. Her previous book, Dangerous Doses: A True Story of Cops, Counterfeiters, and the Contamination of America’s Drug Supply.

That does it for our show. Happy Birthday, Simin Farkhondeh! I’m Amy Goodman. Thanks for joining us.

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