Why Are There So Many Drug Shortages In The U.S.?

JOHN DANKOSKY: Have you ever had the experience of going to the pharmacy to pick up a prescription and being told, we just don’t have that drug right now? Well, I was literally in line behind an elderly woman who got that very unpleasant news just last week. Incredibly, there are some 323 active and ongoing drug shortages in the United States. Just think about that. It’s the highest number of drug shortages since the American Society of Health-System. Pharmacists started tracking that data way back in 2001.

Now, these drug shortages touch every part of the healthcare system, from doctors having to reconfigure their treatment plans to account for this short supply, to patients going from pharmacy to pharmacy to get even the most common medication. But why exactly do these drug shortages happen in the first place? Journalists Indi Khera and Eli Cahan took a deep dive into the tangled web of shortages for us, and they brought us back some answers. Indi and Eli, welcome to Science Friday.

INDI KHERA: Hi. Thank you for having us.

ELI CAHAN: Thanks for having us, John.

JOHN DANKOSKY: So to start, I understand this is a pretty sprawling issue, but you have focused on a few drugs in shortage to help us get our heads around things. Can you tell me a bit more about that?

INDI KHERA: Yeah, definitely. So as you said, drug shortages are complex. This is, I think, the most challenging thing I’ve ever reported on. And so having Eli, who is not only an amazing journalist but also a doctor, was very helpful.

ELI CAHAN: You are too kind, Indi, but, yeah, John, drug shortages, they’re an everyday thing in the hospital. To break the fourth wall for a second, I literally wrote part of this script at 3:00 AM in the morning two days ago after admitting three kids to our ICU, and every last one of them had me calling the pharmacy when we got them upstairs to make sure we could substitute this version of the drug for that one. So, no, we’re not talking a “once in a blue moon,” “toilet paper during the first month of COVID” phenomenon. Shortages are commonplace in medicine today.

INDI KHERA: Yeah, and for the purposes of this story, we ended up focusing on cancer drugs and antibiotics. But given just how complicated shortages are, it’s really easy, I think, to forget who they impact and how serious those impacts can be. So Eli’s context, as someone who is working around these things in a hospital every day, was critical. And we also wanted to find someone who had been directly impacted by a drug shortage.

JOHN DANKOSKY: So did you?

INDI KHERA: Did we ever. I took a little trip to the Twin Cities, where I met Sarah Louise Butler. When Sarah was in her 20s, she worked with students in a K-to-12 after-school program. She kickboxed twice a week and walked a few miles every day. Basically, Sarah was on her feet a lot. But around the age of 25, she started noticing some changes in her body.

SARAH LOUISE BUTLER: I felt that my feet were starting to tighten and swell and hurt when I walked. And then slowly, my hands started to swell and hurt. And then it went to shoulders, knees, hips, jaw, neck, back.

INDI KHERA: Sarah was diagnosed with Rheumatoid Arthritis, or RA, which is an autoimmune disease that can cause chronic joint pain. Sarah describes it kind of like having a sharp pebble in your shoe all the time.

JOHN DANKOSKY: That sounds terrible. I mean, what did her doctor say? Was there a medicine that could help her?

INDI KHERA: Yeah. So Sarah started to take the drug methotrexate in pill form. It’s a really common treatment for RA, and I understand it’s also a really important treatment for certain types of cancer, right, Eli?

ELI CAHAN: Yeah, Indi. Methotrexate is a jack of all trades. We use it for lots of autoimmune conditions like RA, but also things like severe psoriasis. Then there are the cancers, leukemia, osteosarcoma, non-Hodgkin’s lymphoma. There are other conditions, too. Like in ectopic pregnancies, methotrexate can stop cells from multiplying outside the uterus. The drug can literally and very quickly be lifesaving.

INDI KHERA: Sarah’s taking this jack-of-all-trades pill once a week, and it worked for about 13 years. But she and her doctor decided to switch over to the injectable form of methotrexate in 2018.

JOHN DANKOSKY: OK, Eli, could you break down for us why someone might use the injectable form of this medicine versus a pill?

ELI CAHAN: It’s hard to know exactly the reasons in her case without talking to her doctor or going through all of her files. But one common reason would be to make sure that our body is getting the full dose it needs. That’s because in some cases, a person’s gut can struggle to absorb a given drug. It’s also possible she had GI side effects that are common with methotrexate.

INDI KHERA: Yeah. Well, after she made that switch, it didn’t take long before Sarah found herself staring down drug shortages. Sarah noticed that sometimes her local pharmacy wouldn’t have the exact dose or form of methotrexate she needed. And then the pandemic hit. And the whole world, including supply chains, hospitals, pharmacies, was thrown into COVID chaos. And she started having a tough time not just getting methotrexate, but even getting the needles she needed to inject it.

SARAH LOUISE BUTLER: I moved to different drugstores. I gave up on the mail-order system. I felt like I was shopping. And it would always say unavailable. Or my favorite is “on back order.” That’s my favorite one because, like, all right, well, it’s not a pair of pants.

INDI KHERA: Sarah even ran out of methotrexate a few times. And this scramble for every dose stretched beyond the very worst of the pandemic. It went on for about a year. Sarah said it started to feel like a part-time job.

SARAH LOUISE BUTLER: I did break down. And I was on the phone with Walgreens at the time. And I told the lady, I said, I’m really sorry. I don’t normally cry about my health issues, but this is breaking me.

INDI KHERA: Finally, Sarah and her doctor decided the stress just wasn’t worth it anymore. She started on another drug called Cimzia, which has been working great and has been easy to get. But there’s one big difference from injectable methotrexate.

SARAH LOUISE BUTLER: It’s $7,400 a month for two doses. So I think I’m pretty sure I would have stayed on methotrexate because of the cost. It was $20 a month for me out of my pocket.

JOHN DANKOSKY: Wait, what? It was a more-than $7,000 difference?

INDI KHERA: 7,000 bucks. Now, Sarah’s insurance will pick up most of that bill. Plus, she gets a stipend from the manufacturer to help with the rest. But she told us it was still a roughly $50-per-month difference for out-of-pocket costs between Cimzia and methotrexate. And now she’s in a tough place because if something happens and her insurance falls off, well, she could find herself on the hook for that $7,000 bill overnight.

JOHN DANKOSKY: If they’re both used to treat conditions like Sarah’s, and they both work, why exactly is one so much more expensive than the other, though?

INDI KHERA: Yeah, well, methotrexate is a generic drug. Those tend to be older drugs whose patents have expired, which means that multiple drug companies can make the product. They’re supposed to work pretty much the same way as brand names, but they’re cheaper. They make up about 90% of prescriptions filled in the US.

ELI CAHAN: In some cases, like for my 3:00 AM patient the other night, it’s pretty straightforward to sub one med in for another. It’s kind of like Coke and Pepsi at the vending machine. You get whichever one they have. But in some cases, this doesn’t fly. The generic equivalent may not work well against a specific cell type, for example, or it may not work well in a certain small corner of the body. By the time you’re getting to Dr Pepper, to say nothing of a A&W or Brisk, you’re pretty far away from the Pepsi that you started with. And for some cells, John, it’s Pepsi or nothing.

INDI KHERA: But for patients like Sarah, who relied on that generic drug, finding that cheaper alternative was clearly no easy task, which left her with quite a few questions.

SARAH LOUISE BUTLER: I would like to know how did they get behind, or how are their analytics so off that they can’t produce enough?

INDI KHERA: Turns out Sarah’s questions were our questions too, and we set off to get some answers.

JOHN DANKOSKY: So tell me, why was methotrexate so much harder to find consistently?

INDI KHERA: Well, injectable methotrexate is a generic sterile injectable, which is pretty much exactly what it sounds like, generic injections. The FDA studied 163 drugs that went into shortage between 2013 and 2017. Generic sterile injectables made up about half of that sample. I spoke to Marta Wosinska, a senior fellow at the Brookings Institution Center on Health Policy in Washington, DC.

MARTA WOSINSKA: The consequences of a production disruption for a brand are so much greater because they’re losing a lot of profits. When a generic manufacturer has a disruption in production, their margins are so small. It doesn’t have nearly as much of a consequence.

INDI KHERA: An injectable form of methotrexate has been in shortage since early last year. But one expert told me that this specific form is kind of a chronically short drug. In addition to what’s going on now, she said, some form of methotrexate injection has also been in shortage from roughly 2004 to 2008, 2010 to 2015, and 2016 to 2021.

JOHN DANKOSKY: OK, so let me do some math. That means methotrexate has been in shortage for, like, 16 of the last 20 years?

INDI KHERA: Yeah, just about. And before we get into why exactly, I think it would be helpful to paint a little picture of how our generic drugs get to us. Basically, pharmaceutical companies, like Pfizer or Intas, either make or purchase their base ingredients from other manufacturers. These raw materials are called active pharmaceutical ingredients.

This API supply chain, and much of the drug manufacturing supply chain, is spread out across the world. These active ingredients get mixed with water and other buffers, and they’re tested for stability and sterility. And this is a good place to point out that making these injectable generic drugs is no walk in the park. Compared to oral pill forms, it’s an intense. process.

There’s chemically and equipment-y stuff going on. These things get injected right into your bloodstream. So there is very little room for error, and rightfully so. The final form, like, say, a vial of methotrexate, then moves through wholesalers and distributors. And then eventually, someone like Sarah gets their medication, or doesn’t, from a pharmacy or a hospital.

JOHN DANKOSKY: So where exactly in this process were things going so wrong for injectables like methotrexate?

INDI KHERA: Well, it’s kind of a tough thing to pin down exactly, but for an interesting reason. I spoke to Erin Fox. She’s the Associate Chief Pharmacy Officer at University of Utah Health.

ERIN FOX: We know a lot more about other things that we buy than our medications. The medications are probably the most opaque thing that we spend billions of dollars on in this country. Even when you buy a package of lettuce, a lot of times it’ll even list the farm where it was grown. With a medication, you really can have no idea which company made it, where it was made.

INDI KHERA: Where a manufacturer gets its active ingredients, where a final drug is made, and what exactly might be going wrong are kind of mysterious. A lot of the information is often protected as proprietary. Manufacturers are required by statute to tell the FDA if there’s going to be a shortage six months in advance or as soon as they after that. But even once they tell the FDA, the agency might choose to work with them behind the scenes to resolve the shortage before making that information public. The FDA’s goal is, understandably, to avoid a shortage situation.

JOHN DANKOSKY: That makes good sense, of course. Indi, did you find anyone who could tell you why and how these shortages actually happen?

INDI KHERA: Yes I talked to Val Jensen, the associate director for drug shortages at the FDA. She’s an expert on what’s required of manufacturers when it comes to shortages and what isn’t required.

VAL JENSEN: The requirement is really that the company needs to report when there’s a manufacturing interruption that could lead to a disruption in supply. So that’s really their only requirement. They’re also supposed to let us know what they expect to be the duration of the supply interruption.

INDI KHERA: Val told me that manufacturers report the broad reasons behind a shortage to the FDA through email or a form that allows them to check boxes and say things like requirements related to manufacturing or demand increase. But the granular specifics behind those reasons, if it’s a contaminated supply line or what have you, aren’t always shared publicly. And it’s also important to remember here that the FDA can’t just tell a manufacturer to make more of something in a shortage situation.

JOHN DANKOSKY: OK. Then so what’s the reason being given for this methotrexate shortage?

INDI KHERA: So injectable methotrexate is made by several different companies, including Accord Health Care Inc. As of this month, it looks like they do have some supply available, according to the FDA shortage database. But the original reason listed for the shortage was requirements related to good manufacturing practices. Some of the other manufacturers of injectable methotrexate are listed as having it in shortage because of delays in shipping or demand increase.

Now, Accord is a subsidiary of Intas, which is a big, global pharmaceutical manufacturer. It’s tough to say where geographically exactly they or any company really is making injectable methotrexate. But the FDA issued at least two warning letters to Intas last summer and last fall, in which the agency summarized a series of violations at facilities in India– missing data, destroyed records in trash bags, employees altering the time that an operation was performed– just kind of a serious hot mess.

From their side, we heard from a rep with Accord who said since those inspections, they’ve, quote, “implemented a broad range of remediation efforts,” unquote. They say they’ve been looking closely at quality and culture and working with the FDA to release important product. But zooming out, an FDA analysis of 163 drugs that went into shortage between 2013 and 2017 found that manufacturing or quality problems were the reason behind about 60% of those supply disruptions.

JOHN DANKOSKY: Why exactly are so many things going wrong? I mean, you’d think we’d have found a way to guarantee quality in our drug manufacturing process, right?

INDI KHERA: Totally. It’s a million-dollar question, but I’ll let Marta from Brookings summarize it.

MARTA WOSINSKA: A lot of the shortages that we currently see, especially around generic sterile injectable drugs, are, in a sense, a self-inflicted wound because we are allowing the market forces to work in a way that unfortunately undermines the reliability of the system.

JOHN DANKOSKY: So what exactly does she mean by market forces?

INDI KHERA: Well, like we said earlier, generic drugs are supposed to be pretty much exchangeable for each other. And the way Marta describes it, it basically boils down to one factor.

MARTA WOSINSKA: So when a hospital is buying a generic drug, really the only thing that will matter to them is the price.

INDI KHERA: So health systems want low prices. And there are what you can think of as these sort of middlemen entities that negotiate these low prices on their behalf, working between manufacturers, insurers, wholesalers, and the final purchaser, which leads to, as one expert put it, purchasers sometimes paying less for a vial of a drug than a cup of coffee. And that sounds like a good thing that drugs are cheap, but that also means there’s intense low-price competition. And that also might mean manufacturers are looking to cut costs. This downward pressure in generic drug pricing was described to me as the race to the bottom.

JOHN DANKOSKY: Which sounds kind of bad news for these complex drugs.

INDI KHERA: Yeah, exactly. Generic sterile injectables like methotrexate are not easy to make.

JOHN DANKOSKY: So even though someone like Sarah, who we met earlier, is scrambling for this basic medication, because this drug doesn’t make much money for companies, there’s not much incentive to make it or even to keep up the infrastructure to make it.

INDI KHERA: Yeah, pretty much. And that combination of low margins plus an intense manufacturing process also means that one manufacturer can really dominate the market. Like, setting up a factory and getting in the game is not an easy task.

So when a supply line goes down, it can rock the whole system. And we’ve seen that outside of manufacturing issues too, with natural disasters, like that Pfizer plant that got hit by a tornado last year or the plant in Puerto Rico that was damaged by Hurricane Maria. And because there’s not a lot of public-facing transparency around these very complex supply chains and who actually dominates them, it’s hard for the average person to know just how rocked they might get.

JOHN DANKOSKY: Now, we’ve been talking about how very important generic drugs like methotrexate are in short supply because of a complex global production chain and minimal incentives for drug makers to increase that supply. What this means is there are a record-breaking 323 drugs that are hard to get right now. And this list includes some of the most widely used drugs, antibiotics. So you looked at this, Indi. How on Earth did antibiotics run out?

INDI KHERA: It’s a very good question. We focused on penicillin for this story. And the reasons that we can’t get penicillin are a bit different than the reasons we can’t get methotrexate.

JOHN DANKOSKY: OK, I’m listening.

INDI KHERA: So this shortage is hitting a specific form of penicillin called Bicillin L-A. Bicillin is also an injectable. I learned that people in the military have to get it during basic training, and it hurts. A rep with Pfizer told me that it’s nicknamed the peanut butter shot because it’s so thick and goopy.

JOHN DANKOSKY: Ooh!

INDI KHERA: I know. It’s also an old drug. Penicillin was hugely important in World War II. But unlike methotrexate, there is one main manufacturer of Bicillin L-A that I could find, and that’s Pfizer.

JOHN DANKOSKY: Oh, I know those guys. They’re the ones that made my COVID shot.

INDI KHERA: Yeah.

JOHN DANKOSKY: It seems like the problem here might be that there’s just one manufacturer being in charge of this important supply, right?

INDI KHERA: Yeah, you’re totally right. Of all the drug categories, antibiotic manufacturing is notoriously intense. So even though Bicillin is old, and presumably loads of folks could produce it and produce it well, the incentives to get in the game just aren’t really there. So it’s Pfizer and Pfizer alone.

JOHN DANKOSKY: That sounds– I don’t know– not ideal.

INDI KHERA: Not ideal. But here’s the really interesting thing. Bicillin is listed as being in shortage because of demand increase for the drug.

JOHN DANKOSKY: But see, when I think about demand increases for drugs, I’m thinking about things I see ads for, drugs like Ozempic.

INDI KHERA: Yeah, right. I did too, before I started reporting on this story. What I’ve learned, though, is that there’s a qualitative difference between drugs like Ozempic and others like Bicillin. Ozempic is a brandname drug, meaning it’s hugely profitable. And thanks to that profitability, it comes with a playbook–

SPEAKER 2: Discover the Ozempic Tri-Zone.

SPEAKER 3: (SINGING) Oh, oh, oh, Ozempic!

SPEAKER 2: I got the power of there. I lowered my A1C.

INDI KHERA: –like expensive marketing campaigns, commercials, catchy jingles, the whole “ask your doctor about Ozempic shtick.”

JOHN DANKOSKY: Yeah, and I haven’t exactly been seeing splashy ads for Bicillin on the television. So where exactly is this boom in demand for an 80-year-old antibiotic coming from?

INDI KHERA: Well, part of it is in response to how shortages are impacting other drugs. In fact, this whole thing kind of kicked off with the tripledemic. Remember that germy wave of COVID, flu, and RSV? Well, the combo of so many people ending up at the doctor’s office, paired with some similar manufacturing challenges as we laid out earlier, exacerbated a shortage in another antibiotic, amoxicillin, that often gets prescribed to kids for all kinds of respiratory issues. So in response to that, Bicillin L-A started getting prescribed to treat things it would have been used for, like, say, strep throat.

JOHN DANKOSKY: So these antibiotic shortages are connected?

INDI KHERA: Yes. It’s sort of like when a sprinter injures their left leg and then changes the way they run to favor the injured leg and then injures their right leg because their new running technique is faulty. And that’s not just an antibiotic thing, by the way. This happens with other drugs.

JOHN DANKOSKY: But I’m guessing it would take a lot of strep throat to create an entire shortage, right?

INDI KHERA: A lot. But this is not just about strep. It’s also about, of all things, syphilis.

JOHN DANKOSKY: Syphilis, huh. So as in the sexually transmitted infection?

INDI KHERA: That syphilis, yeah. Infection rates have skyrocketed. And Bicillin L-A is the firstline treatment for it. That is especially true in pregnant people with syphilis, for whom other antibiotics can have extremely dangerous side effects. Bicillin L-A is their only safe treatment, and it’s particularly critical right now. Between 2012 and 2022, the number of babies born in the US with syphilis went up from about 300 to almost 4,000.

JOHN DANKOSKY: Wait, so hold it. The shortages are actually impacting our ability to get our arms around the syphilis problem?

INDI KHERA: Yeah, that’s exactly right. You pair what’s going on with a dwindling supply of Bicillin, and it’s bad news. Pfizer confirmed that in early 2023, there was a roughly 70% increase in demand for Bicillin L-A compared to historical rates.

JOHN DANKOSKY: That’s really bad.

INDI KHERA: Yeah. And to make things even worse, the infection is disproportionately impacting the most vulnerable communities. CDC data found that babies born to Black, Hispanic, and Native mothers were up to eight times more likely to have newborn syphilis in 2021 than those born to white mothers. As one doctor put it when I was reporting on this, it demonstrates how we let the same communities down over and over again. And what’s horrible about this is that syphilis is pretty much entirely treatable if it’s identified and managed early enough. It’s a hugely complicated issue of health equity that’s then made even worse by a drug shortage.

JOHN DANKOSKY: So this might be a silly question, but penicillin is such an old drug, Indi. And even amoxicillin feels so basic. Why can’t we just make more of it?

INDI KHERA: It’s not necessarily question, at all, and it was one of my core questions too. I asked Marta, the health policy expert, and someone with Pfizer, and they both explained that manufacturing antibiotics is– you can probably guess what I’m going to say next.

JOHN DANKOSKY: It’s complicated, right?

INDI KHERA: You got it. Marta even said that in certain cases, the antibiotic needs to be made in a totally separate warehouse or room than other drugs to keep it safe from contamination. It’s an industrially intensive process, and so escalating production is no easy task and can take a serious amount of time.

JOHN DANKOSKY: That makes sense. So how have hospitals been responding to these shortages?

INDI KHERA: Yeah, well, the FDA temporarily approved the import of a form of penicillin called extend Extencilline, which is marketed by a French company. And Pfizer says they’ve dramatically ramped up their Bicillin production. I’ve done some reporting on congenital syphilis in Illinois, which is where I live. And it’s worth noting that some of the clinicians and public health officials I spoke to actually hadn’t had a terrible time locating Bicillin, which brings me to another important point on shortages, which is that different health systems, based on things like resources, staff, and who they purchase their drugs from, can have vastly different responses to drug shortages.

JOHN DANKOSKY: OK. Well, as bad as that is, I know that there’s one more drug you guys took a deep dive into. And Indi, I’d like to bring back your colleague Eli Cahan. So Eli, you’re a doctor, and you have a story that’s really hitting some of your colleagues pretty hard.

ELI CAHAN: Yeah, John. And as heartbreaking as the stories we heard related to methotrexate and penicillin were, this is the one that really did us in because it’s about kids, and specifically kids with cancer. Maybe you’ve heard this ad.

SPEAKER 4: What if cancer wasn’t a part of me?

SPEAKER 5: What if my only tests were at school?

SPEAKER 6: What if my body wasn’t a battlefield?

SPEAKER 7: What if I could have my old life back?

SPEAKER 8: What if I could just go home?

ELI CAHAN: The drug that many of these kids need is called vinblastine. It’s a form of chemotherapy used for children diagnosed with Hodgkin’s lymphoma, which is the most common cancer in kids aged 15 through 19 years. Ever since it became the standard of care for treatment of Hodgkin’s, outcomes have improved immensely. But it, too, has been short since September.

To get a better sense of how bad the vinblastine shortages have been, we spoke with a bunch of pediatric oncologists, those people who treat kids with cancer. It’s an impossible job. But they say amid the shortages, it’s a job that’s only gotten harder. Here’s doctor Michael Link, a pediatric oncologist at Stanford University.

MICHAEL LINK: Generally, we tell them it’s a mess, but it’ll get back to normal and your kid will be cured, hopefully, at the end of it. That’s the light at the end of the tunnel. But here, on top of all of this is, my god, I don’t even know if my kid can get the drug that is needed to cure them.

ELI CAHAN: I spent months around these doctors, John. They’re unflappable. You cannot faze them. These kids on the oncology service, they’re so sick, or even worse, they’re pretty healthy, on the outside at least. And then chemo. You start chemo, and these kids, innocent toddlers, earnest pre-teens, sassy teenagers, they become shells of themselves.

I’ve always been struck by how poised these doctors are. And how couldn’t you be? You’re delivering lifealtering news day in, day out. You’re the person injecting the chemo into an eight-year-old spine that makes their hair fall out. It’s all to say, day after day, these doctors are having the hardest conversations you can imagine. Day after day, they do it with the most unfathomable professionalism and grace. It was only when we started talking about the shortages that we saw them lose their cool because, honestly, they’re frustrated.

YORUM UNGURU: These drugs are the backbones of proven and lifesaving regimens not only for kids with cancer, mind you, but for adults as well. But driving this point home is we don’t have an alternative.

ELI CAHAN: That’s Dr. Yoram Unguru, a pediatric oncologist at the Children’s Hospital at Sinai in Baltimore.

YORUM UNGURU: Shortages, they are omnipresent. They smolder along. Now, like we’ve had in other times, it’s a five-alarm fire. They never go away.

ELI CAHAN: From 2009 to 2019, 9 of the 11 drugs used to treat a form of childhood cancer called acute lymphoblastic leukemia were in and out of shortage. So smoldering along is right.

JOHN DANKOSKY: I’m talking with reporters Eli Cahan and Indi Khera about this drug shortage problem in the US. So Indi, you’ve been down this rabbit hole now for months. Are some people working to solve this mess?

INDI KHERA: Yes. The good news is that there’s actually been, I think, quite a bit of recent movement and attention on this front. So one of the big solutions I’ve heard brought up is advancing manufacturing. Like, is there a way to update some of these manufacturing lines? Marta Wosinska, the policy expert from the Brookings Institution we heard from earlier, made a really important point on this front.

MARTA WOSINSKA: There is no free lunch. The reason why we have this problem is because nobody is really willing to spend the money on resilience for our supply chains.

INDI KHERA: She emphasized that advancing manufacturing is not just going to magically happen for free. Someone is going to have to pay for it. In a 2023 paper, Marta and her co-author, Richard G. Frank, propose the possibility of entities like the US Department of Health and Human services, a.k.a. HHS, offering loans to manufacturers to advance infrastructure. They proposed about $2 billion, which isn’t that much in the grand scheme of things. In that vein, in November, the Biden administration gave a green light to HHS to examine the supply chain and invest $35 million into domestic manufacturing of key starting ingredients for injectables.

JOHN DANKOSKY: We also talked about how companies don’t make a ton of money off of making generic drugs. So I see how getting money for these advancements would be kind of tough. Are there any ways to raise these margins at all?

INDI KHERA: Yeah. It would be a big task, but it’s sort of a deep-root solution that Marta has done a lot of research into. In her testimony for the Senate Finance Committee, she described how the Centers for Medicare and Medicaid Services, which reimburse hospitals for drugs, could encourage purchasers to place more weight on reliability over just price when they’re buying drugs.

And that responsibility wouldn’t just rest with hospitals, but also middle players in the supply chain, who negotiate drug prices and tend to have quite a bit of information about what is going on with manufacturers. The Senate Finance Committee released bipartisan draft legislation earlier this year focused on specifically addressing how these middlemen might also be involved in shortages. Lawmakers suggested some changes to current contracting practices, like having minimum three-year contracts with manufacturers of high-shortage drugs, basically just ways to make sure that price negotiation is going fairly and not driving shortages.

JOHN DANKOSKY: Sort of lightening some of that pressure for that race to the bottom we talked about?

INDI KHERA: Precisely. HHS also released a big white paper in April highlighting some of the steps they’ve taken or think would be important since the administration’s big announcement last year. They established a new supply chain and shortage coordinator job and described a way to score manufacturers based on how reliable they are. They could then use those scores to incentivize or penalize hospitals based on where they’re getting their drugs from.

And like we just talked about, the hospitals would rely on the middle entities to help them assess that reliability. But in order for anyone to get a true sense, they need information about the supply chain. And to do that–

JOHN DANKOSKY: I’m going to guess we need to unlock some of those trade secrets we talked about earlier?

INDI KHERA: To score reliability, we need to know where materials and ingredients are coming from. That’s a big key to rearranging our incentive system. Now, experts I spoke to did make the important point that just having information out there doesn’t mean it’s going to be used responsibly or be useful. It could incite panic buying and hoarding. And just knowing that someone is less reliable than someone else without actually acting on it is kind of meh.

JOHN DANKOSKY: So there needs to be intention with that transparency.

INDI KHERA: Precisely. Some potential legislative proposals brought up in the HHS report include requiring that manufacturers disclose all their suppliers to the FDA and share how reliant they are on those suppliers so the agency can jump in more quickly on quality problems.

JOHN DANKOSKY: What’s happening outside of government to try to solve this problem?

INDI KHERA: Yeah, so another organization to note is Civica RX. They’re a nonprofit pharmaceutical company that was specifically designed to try and prevent drug shortages. And you might have heard of Mark Cuban’s company, Cost Plus Drugs, which is trying to make sure everyone has access to affordable medicines.

Angels for Change is also a great organization that advocates for supply chain resiliency and also directly for patients impacted by drug shortages. It was actually started after the founder’s daughter couldn’t get the cancer drug she needed. So there’s policy solutions and outside solutions. But as Dr. Unguru and countless other experts put it, this thing will just kind of keep smoldering along until we take some big swings.

JOHN DANKOSKY: OK. Coming back to where we started, how is Sarah, the patient you spoke with earlier, reflecting on some solutions and her experience now that things have settled down for her a bit?

ELI CAHAN: Sarah seemed happy to have the worst of it behind her, but couldn’t help but think about everyone who might not.

SARAH LOUISE BUTLER: I think about people who didn’t have the time like I did to make those calls. Maybe they had two jobs, kids. What do they do to shop around and try to find this? I am on top of my treatment plan, and I just feel horrible for the people who cannot spend that time shopping for a very inexpensive drug.

JOHN DANKOSKY: Eli and Indi, I’d like to thank you so much for your reporting on this.

INDI KHERA: Thank you for having us.

ELI CAHAN: Thanks so much, John.

JOHN DANKOSKY: Eli Cahan is a journalist and physician in Boston. Indi Khera is a freelance journalist based in Chicago. If you’d like to learn more about how drug shortages happen in the US, you can go to sciencefriday.com/drugshortage. If you’re interested in learning more about science policy, especially in the lead up to election season, you can go to sciencefriday.com/newsletters. You can stay up to date there with Scifri’s coverage of science policy and how it affects people and communities.

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