Popular prescription medicines on display at the Generic Drug Store at the Victoria Hospital in Bangalore, India, on June 28, 2012. Estimates by Dolat Capital show that the U.S. generic market, currently estimated at $350 billion, which is 75 percent of the pharmaceutical industry volume, is expected to grow by around 12-13 percent over 2011-15.

Popular prescription medicines on display at the Generic Drug Store at the Victoria Hospital in Bangalore, India, on June 28, 2012. Estimates by Dolat Capital show that the U.S. generic market, currently estimated at $350 billion, which is 75 percent of the pharmaceutical industry volume, is expected to grow by around 12-13 percent over 2011-15.

The head of the Food and Drug Administration just wrapped up a trip to India. This unusual visit abroad was to address growing concerns at the regulatory agency about the safety of prescription drugs made in India. In the last few months, the FDA has banned the importation of several popular drugs made there, like Accutane and Cipro. The U.S. has come to rely on medicine made overseas. Today, 80 percent of prescription drugs consumed in the U.S. originate in India and China. This has lowered costs, but raised new questions on safety. Diane and her guests discuss prescription drugs made outside the U.S.

Guests

  • Allan Coukell director of drugs and medical devices, The Pew Charitable Trusts.
  • Dr. Jesse Goodman director of the Center on Medical Product Access, Safety and Stewardship and professor of medicine at the Georgetown University Medical Center; attending physician, MedStar Georgetown University Hospital and Washington DC VA Medical Center. He was formerly chief scientist for the Food and Drug Administration.
  • Heather Bresch CEO, Mylan.
  • Dr. Margaret Hamburg commissioner of the Food and Drug Administration.
  • Gardiner Harris South Asia correspondent for The New York Times. He is the author of the mystery novel "Hazard."

Transcript

  • 10:06:53

    MS. DIANE REHMThanks for joining us. I'm Diane Rehm. For most of the last century, the drugs we consumed were made in the U.S., but today, the picture is much different. Most of our prescription drug supply originates in a foreign country. Here with me to discuss medicines made outside the U.S., Dr. Jesse Goodman of the Georgetown University Medical Center, Allen Coukell of the Pew Charitable Trust.

  • 10:07:28

    MS. DIANE REHMJoining us by phone from New Delhi, India, Gardiner Harris of the New York Times. But first, I'll talk with Dr. Margaret Hamburg, commissioner of the Food And Drug Administration. She's just returned from India. Dr. Hamburg, thanks for joining us.

  • 10:07:47

    DR. MARGARET HAMBURGThank you for having me. It's an important topic.

  • 10:07:50

    REHMI'm so you're here. Tell us why you made the trip to India.

  • 10:07:56

    HAMBURGWell, as you noted, today the FDA must behave like a global agency with a global mission because the products we regulate for the promotion and protection of health of Americans here at home depends on the quality and safety of products that are now coming from all over the world.

  • 10:08:19

    HAMBURGAnd in the pharmaceutical space, it's very striking. Eighty percent of the active pharmaceutical ingredients in drugs taken here are actually manufactured in other countries and about 40 percent of the finished drugs are coming from other countries. So we have a global responsibility and now we must have a global presence and reach.

  • 10:08:39

    REHMAnd Gardiner Harris, to you, you wrote from India about serious safety issues there in the drug manufacturing plants. Tell us what the regulatory environment is like there.

  • 10:08:59

    MR. GARDINER HARRISWell, there really isn't one, Diane. I mean, and that's a real reason why I think the Indians were sort of gobsmacked by Peggy's visit. The FDA, because of legislation that passed in 2012, has gotten a lot of extra money, $300 million annually, to step up its inspections of pharmaceutical plants around the world.

  • 10:09:26

    MR. GARDINER HARRISAnd so Peggy has sent out a whole raft of new inspectors to Delhi here and they have tripled the number of plant inspections they've done in the last two years. And not surprisingly, you look, you find and they have found a whole raft of problems at large Indian drug plants. And it's expected that those problems will continue to crop up.

  • 10:09:50

    REHMNow, Dr. Hamburg, who has the upper hand in this situation, India or the U.S.?

  • 10:10:00

    HAMBURGWell, we want to look at it as a partnership and something where quality matters to everyone, for the Indian people, for the American people and for the global marketplace because drugs that are manufactured in India or in other countries are actually distributed all around the globe.

  • 10:10:17

    HAMBURGBut if you're a manufacturer, wherever you're located, if you want to sell you product in the United States, you have a responsibility to meet the standards and regulatory expectations of the U.S. Food and Drug Administration. And that was one of the tough but important messages that I think the Indian industry had to really hear and understand.

  • 10:10:38

    REHMGardiner Harris, do you have any questions for Dr. Hamburg?

  • 10:10:46

    HARRISWell, I think, you know, she did exactly what she needed to do and she's talking in ways that she needs to talk. I mean, she does not this relation to become a combative one. Her best hope, of course, is that the Indians cooperate in what Dr. Hamburg is trying to do. But for her, it's a bewildering, I think, experience for a lot of the inspectors because they can inspect what is before them, the plant that has been registered to sell drugs in the United States.

  • 10:11:19

    HARRISBut what's difficult about the Indian environment is that there are a whole range of facilities here...

  • 10:11:24

    REHMExactly.

  • 10:11:24

    HARRIS...some of which export to the United States, some of which export to Africa and some of which make drugs for the Indian market. And one always has to worry about what is coming in the back door of the facilities that Dr. Hamburg's inspectors are inspecting because in a place where there's a lot of things happening, it's very difficult for the U.S. to control that.

  • 10:11:49

    REHMNow, Dr. Hamburg, you've already excluded Cipro and Accutane. Now how many other potential exclusions might you make on the basis of the trip you just made?

  • 10:12:10

    HAMBURGWell, my trip was at a higher level than actually doing onsite inspections.

  • 10:12:13

    REHMI understand that.

  • 10:12:15

    HAMBURGBut we are present there in an ongoing way. We actually have U.S. FDA offices now in New Delhi and Mumbai with inspectors there and a cadre of international inspectors who can go there or go other places. And we have offices in China, Latin America, South America -- South Africa, I'm sorry, and other places as well because of this need for a global presence.

  • 10:12:39

    HAMBURGAnd what we're doing is trying to do in India and in other countries what we do here. We're trying to achieve the same levels of inspection and enforcement and compliance that we would expect of any company manufacturing drugs for consumption by the American public.

  • 10:12:55

    REHMDo I understand correctly that 80 percent of our antibiotics have some ingredient coming here from China, which is then incorporated into drugs manufactured here and that the Chinese will not allow FDA inspectors into their plants?

  • 10:13:25

    HAMBURGWell, it's not quite that situation. It is certainly the case that in antibiotics and in other important medications, that active pharmaceutical ingredients' components are coming from other countries. And I mentioned the number of 80 percent overall coming in from other countries, China and India being major suppliers of these active pharmaceutical ingredients.

  • 10:13:48

    HAMBURGJust as in India, we are working in China. We actually have office in three different Chinese cities now, Beijing, Shanghai and Guangzhou. That may change a little bit over time, but we're bringing more inspectors into China as well.

  • 10:14:04

    REHMHave they allowed you into their plants to investigate?

  • 10:14:09

    HAMBURGThey have. You know, in China, in India and elsewhere in the world, this is a process. They're not used to this kind of more hands on presence. Other countries, I would add, are starting to do more international inspections as well. And one of the things I wanted to mention that I talked a lot about with both the Indian regulators and industry representatives in India, is that India now, given their incredible and growing role in the global marketplace for pharmaceuticals, really needs to become part of a partnership of regulatory authorities and really be at the table in the discussions that heads of drug regulatory authorities, like myself, have about working together to address what is a global challenge.

  • 10:14:57

    REHMDr. Hamburg...

  • 10:14:59

    HARRISAnd Diane, what...

  • 10:14:59

    REHMGo ahead, Gardiner.

  • 10:15:01

    HARRISWhat she is not saying, because she's playing nice and, you know, the extraordinary thing that what Dr. Hamburg has brought to the commissioner's office is that she's become a, per se, a diplomat for the United States. And what she's not really saying is that the Indians have just disappeared. They have not shown up at multiple conclaves that Dr. Hamburg and many other top regulators around the world have been holding to try to create a kind of a global network of regulators.

  • 10:15:31

    HARRISAnd that's because, you know, the problem with the Indian government is that it just is not there. It's not present in the plants and it's not present in this sort of global set up that Dr. Hamburg is trying to create. And so in many ways, her trip, you know, is sort of -- if Mohammed can't go to the mountain, the mountain comes to Mohammed.

  • 10:15:54

    HARRISYou know, she had to go to India because it was the only way she was going to be able to talk to them. And she needed to get their attention. And I think her trip did that.

  • 10:16:04

    REHMDo you believe your trip did that, Dr. Hamburg?

  • 10:16:08

    HAMBURGI think it was an absolutely crucial step at a critical time. It was not always an easy trip. There were tensions between the U.S. government and India as a backdrop to my visit, but also between U.S. FDA as the regulator having just taken some pretty stiff actions against some Indian companies so the industry representatives and the government officials were a little bit wary, a little bit defensive and a lot concerned.

  • 10:16:40

    HAMBURGBut I think we laid a groundwork for a constructive relationship. We entered into the first statement of intent with the Indian government about a framework for action going forward and our FDA offices in India really are there to both do the inspectional and compliance work that's necessary, but also to build a sustainable oversight and educational system for India and for us.

  • 10:17:04

    REHMDr. Hamburg, I understand the need for diplomacy, getting along, working with other countries, but at the same time, Americans are concerned about safety of the drugs they're taking. How can they know whether a drug they're taking is made in India, is coming from China, how can they know?

  • 10:17:32

    HAMBURGWell, yeah, that is an issue and, of course, many Americans are in healthcare plans where they can't choose which generic version of a drug they're gonna receive as part of their program. So I think, you know, Americans are asking more questions, but, you know, what we are really striving for is a global supply chain that has real integrity, quality built into it and where the products that are coming from other countries meet those same standards.

  • 10:17:59

    HAMBURGThat's why we've taken some of the strong actions that we have when we've seen quality problems because that is not acceptable and in those kind of contaminated counterfeit substandard products will not be allowed in the United States.

  • 10:18:15

    REHMCan we expect any other bans on drugs in addition to Accutane and the other one?

  • 10:18:24

    HAMBURGWell, we have been doing an ongoing series of inspections. As Gardiner said, when you look, you often find. Our goal over time is to have fewer enforcement actions because more compliance with quality.

  • 10:18:35

    REHMDr. Margaret Hamburg, she's commissioner of the Food and Drug Administration. Thank you for being here.

  • 10:18:44

    HAMBURGThank you so much.

  • 10:18:46

    REHMShort break, right back.

  • 10:20:02

    REHMAnd welcome back. Here in the studio Dr. Jesse Goodman. He is director of the Center on Medical Product Access, Safety and Stewardship at Georgetown University Medical Center. He was formerly chief scientist for the Food and Drug Administration. Allan Coukell is director of drugs and medical devices at the PEW Charitable Trusts. And joining us from New Delhi is South Asia correspondent Gardiner Harris of the New York Times. I do welcome your questions, comments. Join us on 800-433-8850.

  • 10:20:52

    REHMGardiner Harris, how serious a problem do you see this importation of drugs from places like India and China to be considering the fact that inspection is so difficult?

  • 10:21:11

    HARRISDiane, there are basically two issues here and Dr. Hamburg, as good as she is, can only address one of them. There is the safety issue which how safe are these drugs considering that we haven't been there. Some of these suppliers in China, frankly Dr. Hamburg's people have not gone into in 10 to 15 years. What she did not say to you was that she has not gotten anywhere close to visas out of the Chinese government that the FDA wants. The FDA's been asking for those additional visas for two years. The Chinese government has refused to give them to the FDA, or at least has not given them to the FDA.

  • 10:21:49

    HARRISBut a second and arguably just as important issue is the security issue. What she did not also say is that we're getting all of our antibiotics from China right now. We are getting all of our steroid medicine -- if you go down the list of medicines that are absolutely essential in hospital settings, and nearly all of them have their crucial ingredients coming from China, were we to get into a bad situation with China and some of these imports were to stop, our health care system would collapse fairly quickly. And no one is addressing this.

  • 10:22:25

    HARRISThe last antibiotic plant in the United States was up in Syracuse, New York. It closed in 2004. No one said a thing. And no one still is saying a thing. That is a real concern that Dr. Hamburg can do nothing about.

  • 10:22:41

    REHMAnd Dr. Goodman, it was not until 2012 that a law actually required the FDA to do these inspections abroad.

  • 10:22:53

    DR. JESSE GOODMANWell, and very importantly began to provide substantive resources, as Gardiner said, so that new people could be hired, could go in and begin the process of looking much more careful at this plant. And I agree that while there's some great initial progress and we're seeing these actions out of that progress, there's a huge way to go. I'm really also glad that Gardiner raised the shortage and security of supply issue. This is something I've been very concerned about.

  • 10:23:24

    DR. JESSE GOODMANThere are many medicines essential to health care or even emergency response in this country were there to be a disaster where it's not just a matter that they may be -- have their ingredients made in foreign countries, but there also may only be a very limited number of suppliers. So if the supply was disrupted for either accidental or intentional reasons there could be serious consequences.

  • 10:23:48

    REHMAllen Coukell, how does the PEW Charitable Trusts get into this?

  • 10:23:55

    MR. ALLAN COUKELLPEW has had a relatively long term focus on drug manufacturing and drug quality issues. And beginning a couple of years ago in the wake of a tragic contamination of a blood thinner called Heparin, we became involved in the issue. And that was a case where the drug was coming from China. Someone in the upstream supply chain of that drug substituted something that was not the correct active ingredient but tested like the correct active ingredient. Made its way all the way into the drug and into the U.S. supply chain and made large number of patients quite sick.

  • 10:24:31

    MR. ALLAN COUKELLAnd that was pretty clearly a deliberate adulteration for economic reasons. So that was not just...

  • 10:24:38

    REHMThat takes my breath away.

  • 10:24:39

    COUKELLThat was not just a case of a lapse in quality standards. That was somewhere somebody deliberately substituting a low-cost ingredient for economic gain.

  • 10:24:48

    REHMSabotage.

  • 10:24:51

    COUKELLFraud. An economic crime with health consequences.

  • 10:24:55

    REHMAn economic...

  • 10:24:56

    HARRISDiane, a deeply evil one. Like, let me be clear that someone substituted a substance that they knew would (unintelligible) initial tests, but what they also knew would probably kill a lot of people afterwards. And this sort of thing is not all that uncommon in the global pharmaceutical industry. You know, the WHO has cited estimates that up to 1 in 5 of medicines sold in India are spurious.

  • 10:25:28

    HARRISAnd many of these medicines -- there was a case recently in Cashmere where hundreds of thousands of antibiotic pills were distributed in public hospitals. Thousands of cases of infants that were in trouble were given an intravenous antibiotic. And those -- and the antibiotic had absolutely no active ingredient whatsoever. And likely this incident caused hundreds, perhaps thousands of deaths. And it's that sort of safety concern that Dr. Hamburg is hoping does not come to the shores of the United States. But as Allen said, it has happened already with the Heparin scare and may have happened in smaller ways that we just don't know about.

  • 10:26:09

    REHMSo explain, Allen, if you would, why that last plant closed in Syracuse in 2004 and why we began transferring manufacture abroad.

  • 10:26:25

    COUKELLWell, I think that you can look at it in two ways. One is we are part of a global economy, and the trends you see in drug manufacturing are the same as the trends you see in almost everything else. But you can also look at the fact that a significant component of the cost of drug manufacturing is the cost of complying with quality standards. And so manufacturers that are operating in an environment where they are not having to comply with those quality standards also have a competitive advantage.

  • 10:26:53

    REHMSo, Dr. Goodman, it sounds as though the U.S. is clearly playing a role here. Because we are willing to transfer a manufacturer to other countries, they are accepting it because we cannot do the kind of investigation and regulation abroad that we could've done here.

  • 10:27:22

    GOODMANWell, I think as Allen said, the globalization of certain kinds of manufacturing and the fact that it's going on now in other countries is a common phenomenon across the...

  • 10:27:31

    REHMYeah, but wait a minute. Wait just a minute. I can see the manufacturer of furniture going abroad. I'm not ingesting furniture. I'm not depending on furniture for my life.

  • 10:27:46

    GOODMANRight. So this is...

  • 10:27:47

    REHMThis is very serious stuff.

  • 10:27:51

    GOODMAN...this is why this is so important. And in fact, you know, I want to also point out that there's tremendous demands from the people in China, the people in India, that their regulatory agencies perform inadequate function and protect them. So many of these problems, as Gardiner said, there have been -- you know, while we've shut down facilities that we saw as putting risk of harm here, there are facilities providing drugs that raise concerns of the ordinary citizen.

  • 10:28:24

    GOODMANSo one thing that Dr. Hamburg is working to work on is that there are also incentives for companies producing in these countries to up their game, improve their quality, etcetera.

  • 10:28:39

    REHMHow long is that going to take, Gardiner Harris? It would seem if they began doing this years ago and their own people have begun complaining, hot long is it going to take to bring that manufacturer of medications up to U.S. standards?

  • 10:29:03

    HARRISOh, I think it's going to be years. And let's be clear, if you are presently taking vitamin C, you are taking a product that has almost certainly been made in China in plants that Dr. Hamburg's people have never gotten into. If you are taking aspirin you are almost certainly taking a product that is being made in either Thailand -- there is one facility down in Brazil, but nearly all of them are from China. And because it's over the counter and the FDA doesn't consider over-the-counter to be sort of risky, those facilities have almost never been inspected by the FDA.

  • 10:29:38

    HARRISSo, you know, again we have these two issues of both safety and security. Now the U.S. government, particularly the Bush Administration, got extremely concerned about the manufacture of flu vaccines that were mostly being done abroad. They started worrying about what would happen during a pandemic. They created and they -- and billions of dollars to try to create a manufacturing infrastructure in the United States for flu vaccines. But to me, it is just astonishing that the government has never expressed concern about what are far more dire medications were the borders to close.

  • 10:30:15

    HARRISIf you don't have infused steroids in a hospital setting, people will die. If you do not have infused antibiotics, people will die. And, you know, our whole system would collapse fairly quickly if these imports were stopped.

  • 10:30:31

    REHMAllen.

  • 10:30:32

    COUKELLNo, I agree. On the question of how long it will take, I think it's an important question. And, you know, one thing we can think about is the analogy to Japanese cars. And you probably remember when they first started coming here in the '70s, they were terrible. And then in relatively short order they completely leapfrogged U.S. manufacturing and became incredibly high-quality automobiles. That potential is here too. This could be fixed fast if there's a commitment on the part of the industry in these countries and the regulators in this countries to do it.

  • 10:31:03

    REHMLet me interrupt you for a moment. People know if a car is not working well. People do not get sick immediately getting into a car that's not working well. I do not think the analogy applies.

  • 10:31:23

    COUKELLIt's an imperfect analogy but there is clearly a risk to a company that can no longer export to the U.S. And so I think when you have the commissioner going with two messages, one is we are going to be there doing stepped-up enforcement. And that's important and we need more of that, but also, that commitment to upgrading the scales of the Indian regulator. Because ultimately we need them to step up.

  • 10:31:43

    REHMOkay. So how long is that going to take, Gardiner, to step up both inspection and enforcement and get the Indians, the Chinese to do their own enforcement? What incentives are there for them if they can continue to send these drugs to us?

  • 10:32:08

    HARRISWell, the incentive is money of course. And, you know, the Indians -- the pharmaceutical industry exports $15 billion worth of products out of India. It is a hugely important industry here. And you -- you know, look, this just happened with their airlines. The FAA in the United States decided that the Indian air regulators were not up to snuff and downgraded India's air safety rating. Their small cars just were determined to be all unsafe by this, you know, global car regulator.

  • 10:32:40

    HARRISSo across the board, Indians are starting to hear back from their counterparts in the rest of the world. And their counterparts are saying, I'm sorry but you're not up to snuff.

  • 10:32:50

    REHMGardiner Harris of the New York Times and you're listening to "The Diane Rehm Show." I want to open the phones, 800-433-8850. Let's go first to York, Penn. Margaret, you're on the air.

  • 10:33:11

    MARGARETHi, good morning.

  • 10:33:12

    REHMHi.

  • 10:33:13

    MARGARETI'm a physician assistant and I prescribe Ciprofloxacin pretty often. And I'm wondering with that drug but more with the others that would be banned down the pike, when can we expect shortages to happen? And how high can we expect prices to go?

  • 10:33:30

    REHMWhat do you think, Dr. Goodman?

  • 10:33:32

    GOODMANWell, I think it's a complicated question and it sort of depends what other number of suppliers in capacity there is in the industry to absorb, in this case Ranbaxy's inability to contribute to that supply. So in some cases when FDA takes an action against a company, there can be implications to supply. So FDA takes those into account because we don't want to cause shortages that are more harmful than the risk of shutting down a plant. So it's a risk-based decision.

  • 10:34:03

    GOODMANBut this problem of improving quality in manufacturing is very linked to shortages because many shortages occur when either a company or FDA or another regulator says, we need to fix a problem in manufacturing.

  • 10:34:20

    REHMAll right. And to Doreen in Trion, N.C. You're on the air.

  • 10:34:27

    DOREENHi, Diane. It's an honor to speak with you.

  • 10:34:29

    REHMThank you.

  • 10:34:30

    DOREENI was hit in the head about four years ago by a metal post which sent me flying through the air. I became ill after that. My thyroid had problems, I was weak, I was shaky, I had palpitations. I was really in bad shape. About a year ago we found out that I wasn't producing any ACTH because the pituitary had been damaged. So I was placed on generic hydrocortisone. I never improved. My thyroid status did not improve. Every time I took a pill I would get shaky. I'd start to perspire. My heart would get more irregular.

  • 10:35:07

    DOREENI couldn’t think. I would stagger around. I fell. I broke my foot. I mean, I just had a lot of problems. And in the ensuing year I've developed a horrible colitis. And I blame it on the fact it was generic hydrocortisone. So around -- just in November I asked my doctor to give me a prescription for Cortef, the brand name. I took it and I started to feel better. Just before -- the Thursday before Christmas I called his office and asked that it be renewed instead of the generic. And there was a glitch in the faxing apparently because it wasn't renewed.

  • 10:35:40

    DOREENSo when I went to pick it up there was no Cortef. I was forced to take the generic for four days because Christmas fell in there and they had to order the Cortef. After four days I became extremely unstable. I had rapid mood swings.

  • 10:35:57

    REHMAll right.

  • 10:35:58

    DOREENAnd I became very weak. I began to lose vision, which happens...

  • 10:36:02

    REHMSo it sounds as though you felt very strongly that it was the generic that did that.

  • 10:36:06

    DOREENOh, it was definitely the generic because now I'm on the Cortef and I'm doing much, much better. When I...

  • 10:36:12

    REHMOkay. Thank you. Here's what I want to ask. Are more generics in trouble because they're produced abroad than the real stuff, Dr. Goodman?

  • 10:36:33

    GOODMANWell, problems have occurred with both generics and brand name drugs.

  • 10:36:36

    REHMAll right.

  • 10:36:37

    GOODMANAnd brand name drugs, in many cases, their active ingredients or even the finished drug may be produced abroad. However, generic drugs are tightly regulated. FDA recently got increased funding to be able to do more inspections of generic facilities, etcetera. One of the things that our audience can do today is if you think you have a problem with the quality of a drug, whether branded or generic, and it doesn't perform and you have an experience like this caller just related, please report it to FDA's Med Watch so that it can be investigated.

  • 10:37:12

    REHMFDA Med Watch. Okay. Short break here. More of your calls when we come back.

  • 10:40:00

    REHMAnd welcome back. Joining us now by phone is Heather Bresch. She's CEO of Mylan, that's a generics and specialty pharmaceutical company. Thank you, Heather, for joining us. I know you were one of the leaders pushing for more inspections in countries like India. Tell us why.

  • 10:40:28

    MS. HEATHER BRESCHHi. Well, good morning, Diane.

  • 10:40:29

    REHMHi.

  • 10:40:31

    BRESCHMylan has been in the pharmaceutical business now for over 50 years, but for the first 45 years we were located in the United States. Our facilities were in the United States and we only sold in the U.S. market. So we were a domestic player for many years. And obviously very familiar with the FDA standards of inspections at least every two years to require good manufacturing practices. We then acquired companies and went global in 2007.

  • 10:41:03

    BRESCHIn learning and understanding the global industry became aware that there was unlevel playing field. That FDA did not have the resources, nor the standing, to get to foreign facilities at the same rate they were in the United States. So when I came back to investigate why that's the case, I realized the law was silent. The law was written in 1938 and had not really been touched significantly since 1938. And we were a very domestic society in 1938. I think that as all your show so far this morning has discussed, we are a global industry and FDA was a domestic agency trying to govern a global industry without the right financial resources or standing to do so.

  • 10:41:51

    REHMOkay. But I have a question for you, and it comes from Susan. She says, "How many of the foreign plants, as in India, are owned by U.S. multinational pharmaceutical companies? And how helpful are these companies being in helping with safety inspections?" What about Mylan?

  • 10:42:20

    BRESCHWe own facilities all over the world and many in India. We have always said Mylan, as a company, holds all of our facilities to the same quality standard. So we don't make product differently for the U.S., then we make it for Africa or India or anywhere else we sell our product around the globe. Not all companies can tell you that, whether they're U.S. based or India based or China based. Many companies have different standards and sell different products to different parts of the world.

  • 10:42:49

    REHMAll right. But do you feel that your company is responsible for safety in those foreign plants or do you feel it's the FDA's responsibility?

  • 10:43:06

    BRESCHWe certainly feel responsible and have said that quality is not a department and can't be one person. It's the culture or the DNA of your company. I believe there are good companies and bad companies everywhere in the world, here in the U.S. included. I think as a society we've made the determination, though, that self-governing is not good enough. I think if that were the case, why do we govern anything here in the U.S., why do we have people go and inspect, why do we have policemen?

  • 10:43:34

    BRESCHBecause we want that oversight. So we absolutely hold ourselves responsible and hold our facilities to that standard. With that being said, I can't speak for everybody else. So to have a level playing field is where you need regulators like the FDA that are holding -- if you're not looking for anything, you're not going to find it.

  • 10:43:54

    REHMAll right. And, finally, are we too reliant? Have we become too reliant on drugs made abroad? Should generics come back to the U.S. where U.S. oversight can be right here?

  • 10:44:16

    BRESCHLook, I think that we have gotten ourselves into a huge issue here out of the United States by letting so much of the products being imported and losing sight -- I think as Gardiner and others were talking about earlier -- losing sight about almost now 100 percent, like antibiotics, 100 percent of antibiotics are made outside of the U.S. I think that's a hugely strategic issue. And I think that as the United States government, we need to look at strategic sourcing, because right now we've let the leverage go into China and India.

  • 10:44:52

    BRESCHSo China can be reluctant to give us Visas, not even let FDA in to visit plants they need to, yet we're not in a position to say you can't come into the U.S. unless you allow that to happen. We need to reverse that. You can't do it over night. This is something that's happened over the last 30, 40 years, but we absolutely need to have that pendulum come back so that we have the leverage to say if your facility is not under good manufacturing practices you can't ship into the U.S.

  • 10:45:19

    REHMHeather Bresch, she's CEO of Mylan, that's a generics and specialty pharmaceutical company. Thanks so much for joining us.

  • 10:45:30

    BRESCHAll right. Thank you.

  • 10:45:32

    REHMAnd, Dr. Goodman, you wanted to add to that.

  • 10:45:35

    GOODMANYeah, I wanted to build on something just said, and that Gardiner also mentioned. The flu vaccine experience was one where -- and I was involved in some of the government decision making around this -- where we knew that to protect the national security of this country, particularly in a pandemic, we needed to have domestic-based manufacturing capacity. And we also needed foreign capacity of high quality because a pandemic is a global event.

  • 10:46:01

    GOODMANBut as he said, the government invested in building an influenza vaccine manufacturing infrastructure in this country and a government partnership with industry capable of dealing with a public health crisis. And that stood us in good stead, for example, in 2009 and as we look at new viruses emerging from China all the time. I think, even if manufacturing overseas was perfect, that the situation where we may have 100 percent of certain critical antibiotics that we're dependent on one area of the world -- and we don't necessarily have the capacity in the U.S. to do this -- it reminds me of many other critical things.

  • 10:46:40

    GOODMANLike in defense, we don't say that we can make all our tanks in one place and can't make them in the U.S. And I think it is time for an examination, for some of the most critical drugs -- and it's not just drugs, medical supplies, masks are all made overseas. Do we need to think about having at least some resilient manufacturing capacity built in this country?

  • 10:47:03

    REHMGardiner Harris, do you want to comment?

  • 10:47:06

    HARRISWell, I think Dr. Goodman has got it right. I mean I think this is a real problem that the government has failed to address almost entirely. And all of this sort of happened without anybody noticing. I mean when that Syracuse antibiotic plant closed, I actually talked to the folks. It was a Bristol Meyers plant. I talked to the executives involved. And I asked them, "Did anyone ever call you guys from the government to sort of say, 'Hey, geez guys, this is the last antibiotic plant in the United States. Maybe we can come to some sort of arrangement.'" Well, no. No one did.

  • 10:47:42

    HARRISAnd that's true across the board with steroids and with all these other -- with aspirin. I mean aspirin is a miracle drug and we don't make it here. And the last Western plant was actually in France. And I went to that plant just before it closed and wrote a story about the last Western aspirin plant closing. And, again, nobody from any government went there and sort of said, hey, let's talk turkey.

  • 10:48:09

    REHMAllan Coukell, you said during the break, it's not just foreign products. It's products made here in the U.S. as well.

  • 10:48:18

    COUKELLWell, I think it's an important point. And there are serious quality problems in India and China. There are also great facilities in India and China. Similarly, one of your earlier callers talked about drug shortages. Over the past couple of years we've had huge problems of essential medicines not being available here because the plants that made them have had quality problems. And for a lot of those drugs, they're sterile injectable drugs, and they're made in the U.S. So quality is an issue everywhere.

  • 10:48:45

    REHMAll right. Let's got to Harold, in Williamsburg, Va. You're on the air.

  • 10:48:51

    HAROLDGood morning, Diane.

  • 10:48:53

    REHMHi there.

  • 10:48:54

    HAROLDFollowing on the tail of the aspirin remark, I'm reading my Bayer label, which says, "Made in Spain." But that aside, I'm just wondering why someone hasn't urged the government to come up with some type of subsidies or co-involvement in order to bring that manufacturing back. Cities are giving breaks, New York has the ten-year-no-tax thing. There's all types of things that could be done in terms of the government encouraging and incentivizing the relocation of plants to here where we could inspect and control to a greater degree, than hoping someone in another country might do it eventually.

  • 10:49:38

    REHMAll right. Thanks for your call. Gardiner?

  • 10:49:41

    HARRISWell, there's several things going on here, Diane. I mean 10 percent of the money that we spend on our healthcare system goes to drugs. So it's a huge amount of money. And generic drugs have now become somewhere between 80 and 85 percent of the medicines that we all take. There is no question about sort of going back to the branded drugs. And as Allan said, it's not like the branded drug makers have distinguished themselves in their own quality effort.

  • 10:50:06

    HARRISThey have gotten into trouble again and again and again. Two years ago, GlaxoSmithKline paid an $800 million fine because their manufacturing had been so woeful and they'd like about it so often that the Justice Department came down so hard on them. So these problems are global problems from a safety perspective. But I think from a strategic perspective, look, Jesse Goodman was deeply involved.

  • 10:50:31

    HARRISHe's not giving himself enough credit. He and his wife, actually -- they made most of these decisions over their breakfast table actually -- but they were deeply involved in making sure that the United States had a much better capacity to deal with a pandemic. They were extremely successful. There's really no reason why those sorts of efforts cannot be extended to a whole range of critical medicines.

  • 10:50:58

    REHMAnd yet, you don't see it happening yet, Dr. Goodman.

  • 10:51:03

    GOODMANWell, I think this is a really important dialog. I do think, as Gardiner said, it's unrealistic to turn back the clock. But I think we have to ask, can we restore some of the balance. And I don't think -- we are becoming one world. As I said, the people of India, the people of China, the people of Africa, they want the same things the people in this country want. They want good vaccines for their children. They want safe drugs.

  • 10:51:27

    GOODMANIt is moving in that direction. I think one of the things FDA can do, one of the things I hope to contribute to from academia, is helping other countries get there, helping us all collaborate.

  • 10:51:38

    REHMAll right. I asked this question earlier and Harold, in Williamsburg, just had one answer. He looked on the label of his aspiring, which was made in Spain. But how can I, with my prescription drug, know exactly where it's coming from? There's a lab label on that prescription, but it doesn't give me a country of origin. Allan?

  • 10:52:10

    COUKELLThat's absolutely right. And even in a case -- and I can't speak to Bayer aspirin specifically -- but even in a case where it says made in country X, there is every chance that there's an upstream supply chain, which perhaps the finished tablet was made in that country, but the active ingredient comes from further upstream.

  • 10:52:25

    REHMSo are you telling me there's literally no way that consumers can know, other than to take that drug, find out it's not working. Is that the only way?

  • 10:52:40

    COUKELLI think it's fair to say that in general it would be hard for consumers to know where their specific product had come from.

  • 10:52:45

    REHMShouldn't…

  • 10:52:46

    HARRISDiane, what's frightening about this, is that even the FDA, until very recently, didn't know where all these medicines were coming. Part of that 2012 legislation, was that FDA required these manufacturers to start paying an annual registration fee. And what FDA really was looking for was finding out actually who was going to pay the fee. FDA didn't actually know who was an active manufacturer. They had this very long list. They were decades old.

  • 10:53:14

    HARRISMany of the companies on there had long ago stopped making it. So what FDA did, by requiring the manufactures pay an annual fee, is to find out who out there was willing to pay the fee. And it's only if you're actually making drugs that you can pay the fee.

  • 10:53:29

    REHMAnd you're listening to "The Diane Rehm Show." So let's now go to Rosanna, in Miami, Fla. You're on the air.

  • 10:53:42

    ROSANNAThank you so much, Diane, for taking my call.

  • 10:53:44

    REHMYes.

  • 10:53:44

    ROSANNAMy question is -- I'm sure it's not an original one -- I'm a scientist. And I always wonder why the basic medications, the ones that we depend so much, are not made in a frame like NIH, so we make them, the government makes them. And we have already the regulation and the standard in a place that is ours and not contracted out and not have all these problems about being able to look at them and inspect them also. And I'm not saying...

  • 10:54:14

    REHMInteresting question, Rosanna. Thank you. Isn't this a matter of national security, Dr. Goodman?

  • 10:54:23

    GOODMANWell, I think that's a really interesting question. It is a matter of national security that we have the essential drugs we need. I don't think historically the government has been good or a place to do manufacturing. And, you know, for example, when I was at FDA we saw that the manufacturing expertise was with the companies that do it the best. Not the companies that don't do it well, but the companies that do it the best.

  • 10:54:49

    GOODMANSo I think what we need to do to address this problem is work with industry, both where they have quality problems, to improve it, but where they don't, to say how can we better prepare or prevent quality problems elsewhere. How can we prevent shortages? Is government investment needed? One thing I didn't get a chance to raise, that's an issue here, is that -- and we saw this with flu vaccine. These very low-cost drugs save hundreds of billions of dollars to the healthcare system. That is a great thing.

  • 10:55:21

    REHMBut if they don't do any good, it's not saving anybody anything.

  • 10:55:25

    GOODMANNo, that's right. And most generic drugs work and perform -- and the law is that they have to do that. However, competition is largely based on price. And as you were saying comparing the car to the drug. You can't tell from holding up a vial, is that something that was really produced in an A-plus way or C-plus way?

  • 10:55:47

    REHMAnd what about, Gardiner Harris, the idea of weeding out those plants that are not living up to standard?

  • 10:55:58

    HARRISWell, I think that's actually what is really frightening the Indians right now. Because, as we talked about here, one of the reasons why India's pharmaceutical industry has thrived so much was precisely because no one was in the plants watching what is going on. Heather Bresch, if you'd asked her, would've said basically that her plants, when she makes them to FDA standards, it's about 25 percent more in costs. So these plants in India have had an enormous advantage for years and years and years.

  • 10:56:31

    HARRISAnd with the FDA going into India right now -- I spoke to one of the major manufacturers there. He's not sure he's going to expand in India anymore. It's tough.

  • 10:56:43

    REHMGardiner Harris, South Asia correspondent for The New York Times. Allan Coukell of the Pew Charitable Trusts. Dr. Jesse Goodman, formerly chief scientist for the FDA. He's now at Georgetown University. Thank you all so much. I think we'll be talking about this more as time goes on. Thanks for listening all. I'm Diane Rehm.

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