Latest news with #Bicillin
CNN
16-07-2025
- Health
- CNN
A new recall of injected penicillin may put gains against syphilis in peril
Drugmaker Pfizer is warning doctors that it expects to run low on supplies of Bicillin L-A, a long-acting injection of the antibiotic penicillin, the preferred option for treating syphilis during pregnancy. The news – the latest twist in a drug shortage that began in 2023 – follows a July 10 recall of certain lots of Bicillin L-A that were found to be contaminated with floating particles. Pfizer says it has not received any reports of adverse events related to the recalled shots. 'We have identified the root cause to be associated with stoppers supplied from an external vendor and are implementing the appropriate corrective and preventative actions,' the company said in a statement, adding that it places the utmost emphasis on patient safety. 'We fully recognize the importance of this medicine for patients and are working as quickly as possible to resolve the matter.' Benzathine penicillin G, sold as Bicillin, is used to treat a number of common bacterial infections, such as strep throat, in adults and children. Because one shot can last up to two weeks, it's especially helpful for people who can't swallow pills or may not be able to remember to take them. In most cases, however, if the shots aren't available, doctors can turn to alternatives like the antibiotic doxycycline. But benzathine penicillin G is the only product that's approved and recommended to treat the sexually transmitted infection syphilis during pregnancy. If the infection is caught early, a single injection can keep the infection from spreading to a newborn, a condition called congenital syphilis. Without treatment, syphilis during pregnancy can cause miscarriages and stillbirths. It can also be fatal for infants. Syphilis can also cause vision and hearing problems in babies as well as deformities of the bones and teeth. As rates of syphilis rose in adults, more babies became infected, too. Over the past decade, rates of congenital syphilis have increased tenfold in the United States, from 335 in 2012 to more than 3,800 in 2023, according to data from the US Centers for Disease Control and Prevention. 'We're in the midst of a congenital syphilis crisis, and we've been calling for an emergency declaration for congenital syphilis for years,' said Dr. Jeffrey Klausner, a professor of clinical population and public health sciences at the University of Southern California's Keck School of Medicine. 'This threatens to make that even worse.' The shot has been a key part of the strategy that some states have been using to quell rising rates of congenital syphilis. Because too many pregnant patients infected with syphilis weren't making it into basic primary care, there's been a push in states including New Mexico and Minnesota to test all pregnant women for syphilis at multiple stages of pregnancy and whenever they show up in emergency rooms or urgent care clinics. After an initial positive test, providers are encouraged to treat a pregnant patient with a shot of long-acting penicillin at the same visit, without waiting for the results of a second confirmatory test. This push for one-stop testing and treatment has already had an effect. 'With the latest release of data, we saw a slowing of rates, which was really exciting,' said a CDC official familiar with the data who asked not to be named because they weren't authorized to speak to the media. That progress is the result of hard work bringing awareness to controlling syphilis and congenital syphilis, the official said. Bicillin L-A most recently went into shortage in 2023. During that time, the US Food and Drug Administration has allowed imports of two equivalent products, a French drug called Extencilline, and Lentocilin, which is imported from Portugal and sold by entrepreneur Mark Cuban's Cost Plus Drugs. These imports continue to be authorized. Those forms of the medication are trickier to use, said Erin Fox, associate chief pharmacy officer at the University of Utah Health. 'In a health system, it's very hard to use imported products,' she said. The bar coding on the drugs isn't recognized by most hospital systems, and there may be differences in how the products are mixed and diluted, which can be confusing. Her hospital has been handling the shortage by being judicious about who gets Bicillin shots. It hasn't had to use an imported products yet. Pfizer has also been working to boost its supply. The company stopped shipping pediatric doses in 2023 and instead focused on making adult doses to prioritize supply for pregnant patients. According to the FDA's drug shortage website, Pfizer expected to have a delivery of pediatric doses available in October. Now, the company has advised customers that it will give an update on the Bicillin supply no later than mid-August. Until stock has fully recovered, Pfizer said, it will ration available supplies of the shots. Providers will have to fill out medical request forms, and the company will send supplies on a per-patient basis. Sterile injectable products like Bicillin are especially vulnerable to shortages because they have a more complex manufacturing process than pills and tend to be prone to quality control issues. In this case, Pfizer is the sole supplier of Bicillin for the US. The nonprofit National Coalition of STD Directors said it's gathering information from members to understand how far-reaching the impact of the recall may be. One of its committees met Monday, and all of the participants were in the process of returning Bicillin doses to Pfizer. One state returned about 800 vials, 'so we expect to hear this is widespread,' said Elizabeth Finley, senior director of communications and programs for the organization. 'We had a small reprieve for about, maybe a year, in terms of steady supply. And now this is just a complete kick in the teeth and really threatens our ability to prevent and control syphilis,' Klausner said. The CDC had previously posted recommendations for caring for syphilis patients during the shortage, but that information has since been taken down. Fox, who investigates drug shortages for the Association of Health Systems Pharmacists, said she has asked the agency to repost it but hasn't received a response. CDC staffers who work on syphilis control were hit hard by recent government layoffs, although about 200 were reinstated in June. Federal funding cuts have also hampered state and local efforts to control sexually transmitted infections. The FDA updated its drug shortage page with links to Pfizer's recent guidance but has not posted Pfizer's recall announcement. A spokesperson for the US Department of Health and Human services referred questions about the recall and potential supply problems to Pfizer. 'I am concerned though that now, with a cut in funds to national and local STD programs, that we will start to see a drop in testing for syphilis,' the CDC official said. 'Cuts to Medicaid and Medicare, as well as other programs, will be devastating for syphilis control.'
CNN
16-07-2025
- Health
- CNN
A new recall of injected penicillin may put gains against syphilis in peril
Drugmaker Pfizer is warning doctors that it expects to run low on supplies of Bicillin L-A, a long-acting injection of the antibiotic penicillin, the preferred option for treating syphilis during pregnancy. The news – the latest twist in a drug shortage that began in 2023 – follows a July 10 recall of certain lots of Bicillin L-A that were found to be contaminated with floating particles. Pfizer says it has not received any reports of adverse events related to the recalled shots. 'We have identified the root cause to be associated with stoppers supplied from an external vendor and are implementing the appropriate corrective and preventative actions,' the company said in a statement, adding that it places the utmost emphasis on patient safety. 'We fully recognize the importance of this medicine for patients and are working as quickly as possible to resolve the matter.' Benzathine penicillin G, sold as Bicillin, is used to treat a number of common bacterial infections, such as strep throat, in adults and children. Because one shot can last up to two weeks, it's especially helpful for people who can't swallow pills or may not be able to remember to take them. In most cases, however, if the shots aren't available, doctors can turn to alternatives like the antibiotic doxycycline. But benzathine penicillin G is the only product that's approved and recommended to treat the sexually transmitted infection syphilis during pregnancy. If the infection is caught early, a single injection can keep the infection from spreading to a newborn, a condition called congenital syphilis. Without treatment, syphilis during pregnancy can cause miscarriages and stillbirths. It can also be fatal for infants. Syphilis can also cause vision and hearing problems in babies as well as deformities of the bones and teeth. As rates of syphilis rose in adults, more babies became infected, too. Over the past decade, rates of congenital syphilis have increased tenfold in the United States, from 335 in 2012 to more than 3,800 in 2023, according to data from the US Centers for Disease Control and Prevention. 'We're in the midst of a congenital syphilis crisis, and we've been calling for an emergency declaration for congenital syphilis for years,' said Dr. Jeffrey Klausner, a professor of clinical population and public health sciences at the University of Southern California's Keck School of Medicine. 'This threatens to make that even worse.' The shot has been a key part of the strategy that some states have been using to quell rising rates of congenital syphilis. Because too many pregnant patients infected with syphilis weren't making it into basic primary care, there's been a push in states including New Mexico and Minnesota to test all pregnant women for syphilis at multiple stages of pregnancy and whenever they show up in emergency rooms or urgent care clinics. After an initial positive test, providers are encouraged to treat a pregnant patient with a shot of long-acting penicillin at the same visit, without waiting for the results of a second confirmatory test. This push for one-stop testing and treatment has already had an effect. 'With the latest release of data, we saw a slowing of rates, which was really exciting,' said a CDC official familiar with the data who asked not to be named because they weren't authorized to speak to the media. That progress is the result of hard work bringing awareness to controlling syphilis and congenital syphilis, the official said. Bicillin L-A most recently went into shortage in 2023. During that time, the US Food and Drug Administration has allowed imports of two equivalent products, a French drug called Extencilline, and Lentocilin, which is imported from Portugal and sold by entrepreneur Mark Cuban's Cost Plus Drugs. These imports continue to be authorized. Those forms of the medication are trickier to use, said Erin Fox, associate chief pharmacy officer at the University of Utah Health. 'In a health system, it's very hard to use imported products,' she said. The bar coding on the drugs isn't recognized by most hospital systems, and there may be differences in how the products are mixed and diluted, which can be confusing. Her hospital has been handling the shortage by being judicious about who gets Bicillin shots. It hasn't had to use an imported products yet. Pfizer has also been working to boost its supply. The company stopped shipping pediatric doses in 2023 and instead focused on making adult doses to prioritize supply for pregnant patients. According to the FDA's drug shortage website, Pfizer expected to have a delivery of pediatric doses available in October. Now, the company has advised customers that it will give an update on the Bicillin supply no later than mid-August. Until stock has fully recovered, Pfizer said, it will ration available supplies of the shots. Providers will have to fill out medical request forms, and the company will send supplies on a per-patient basis. Sterile injectable products like Bicillin are especially vulnerable to shortages because they have a more complex manufacturing process than pills and tend to be prone to quality control issues. In this case, Pfizer is the sole supplier of Bicillin for the US. The nonprofit National Coalition of STD Directors said it's gathering information from members to understand how far-reaching the impact of the recall may be. One of its committees met Monday, and all of the participants were in the process of returning Bicillin doses to Pfizer. One state returned about 800 vials, 'so we expect to hear this is widespread,' said Elizabeth Finley, senior director of communications and programs for the organization. 'We had a small reprieve for about, maybe a year, in terms of steady supply. And now this is just a complete kick in the teeth and really threatens our ability to prevent and control syphilis,' Klausner said. The CDC had previously posted recommendations for caring for syphilis patients during the shortage, but that information has since been taken down. Fox, who investigates drug shortages for the Association of Health Systems Pharmacists, said she has asked the agency to repost it but hasn't received a response. CDC staffers who work on syphilis control were hit hard by recent government layoffs, although about 200 were reinstated in June. Federal funding cuts have also hampered state and local efforts to control sexually transmitted infections. The FDA updated its drug shortage page with links to Pfizer's recent guidance but has not posted Pfizer's recall announcement. A spokesperson for the US Department of Health and Human services referred questions about the recall and potential supply problems to Pfizer. 'I am concerned though that now, with a cut in funds to national and local STD programs, that we will start to see a drop in testing for syphilis,' the CDC official said. 'Cuts to Medicaid and Medicare, as well as other programs, will be devastating for syphilis control.'
Yahoo
09-04-2025
- Business
- Yahoo
Trump drug tariffs would drive up prices, worsen shortages before any boost to US manufacturing, experts warn
'Major' tariffs on pharmaceutical imports are coming soon, President Donald Trump says, pledging that they'd help bring drug manufacturing back to the US while lamenting that other countries pay much lower prices for the same medicines. Instead, patient advocates and drug supply chain experts warn, tariffs are likely to drive the price of medicines higher and exacerbate already dangerous drug shortages. Whether they influence manufacturers to make more drugs in the US is a source of debate, and any increase in production is at least several years away. 'We're going to be announcing very shortly a major tariff on pharmaceuticals,' Trump said Tuesday at the National Republican Congressional Committee dinner, although he didn't specify the size of the tariff or when it would be implemented. Medicines had been exempted from the president's 'Liberation Day' tariff announcement April 2, causing the industry to breathe a brief sigh of relief. The president had also exempted the industry from the tariffs he imposed in his first term. In his tariffs speech last week, Trump said it was a 'tremendous problem' that 'the United States can no longer produce enough antibiotics to treat our sick.' That problem may get worse if tariffs come into play, experts warned while agreeing that it's a problem that needs fixing. The impacts of tariffs could be largest for generic drugs, which make up about 90% of the medicines prescribed in the US and many of which rely on ingredients made in China and India. Generic drugs, whether they're antibiotics, diabetes drugs or statins to lower cholesterol, sell for 'pennies per dose,' said Tom Kraus, vice president of government relations for the American Society of Health-System Pharmacists. Increasing the cost of ingredients that go into them 'can make it so that it's no longer profitable to sell that drug in the United States.' Already, shortages of antibiotics are a major problem in the US. Antimicrobials are among the most common drugs to be in short supply, with 40 active shortages in the US as of the end of 2024, according to data from the American Society of Health-System Pharmacists. Antibiotics currently in shortage include amoxicillin, commonly used for strep throat and ear infections, and Bicillin, crucial for treating syphilis infections. Other especially precarious medicines include sterile injectable drugs used in hospitals. Those can be products as simple as IV saline bags or injectable dextrose, used in emergency settings, as well as cancer chemotherapy drugs. They're required to be manufactured under pristine conditions and have been in shortage for years because of low prices and market disruptions. 'Added costs to already low-margin products may be a tipping point for companies to discontinue production,' said Erin Fox, a drug shortages expert at University of Utah Health. 'I'm worried we'll see discontinuation and a less resilient supply chain if companies quit making essential products.' An estimated 40% of generic drugs have only one or two suppliers making their ingredients, said Rena Conti, an associate professor at the Boston University Questrom School of Business. 'That's a pretty fragile supply,' Conti said. 'If one of those manufacturers exits, well, then we're a little bit in a pickle' – causing challenges for pharmacies and hospitals in stocking the drugs in the coming months. Consumers, meanwhile, could have trouble finding the medications they need when they go to the drugstore. And when one manufacturer is the sole supplier of a medicine, prices often rise. That can sometimes be astronomical, even for generic medicines – such as when Martin Shkreli, known as the Pharma Bro, raised the price of a medicine used by people with HIV from $13.50 to $750 overnight. Public and political pressure has made moves like that less common, but they still occur. But for many generic medicines, especially sterile injectables, it may be difficult for manufacturers to pass along price increases, said Dr. Marta Wosińska, a senior fellow at the Brookings Center on Health Policy. 'One reason is immediate – group purchasing organization (GPO) contracts,' Wosińska wrote in an article analyzing the potential effects of tariffs. 'All hospitals use GPOs to contract for sterile injectable generics used in inpatient settings, with those contracts locking in prices but not quantity.' Those contracts generally last one to three years, she noted, 'and may limit price increases.' Moreover, 'there are laws that make increasing prices faster than inflation a problem for a drug company,' said David Maris, a managing partner at Phalanx Investment Partners who spent years as a financial analyst following the drug industry. 'So I am not sure how they would even be able to pass along the increase.' For branded medicines – those that still have patent protection and don't face cheaper generic copycat competition – it could be a different story, Maris said. There, it would be tariffs from Europe that could hit hardest, with a huge amount of drug manufacturing in countries including Ireland, which has a favorable tax environment. Ingredients for a branded drug may make up only 10% of the total cost to produce a product, Maris estimated, 'so if that 10% rises by 35%, the overall impact on production costs is relatively small.' Unlike with generic medicines, makers of branded drugs have more cushion to absorb price increases, Maris pointed out. But he doesn't think they will. 'These costs will be passed on, leading to higher drug prices,' he said. 'For consumers with insurance, that likely means higher premiums and potentially higher out-of-pocket copays.' Already, the US pays the highest prices for drugs in the world, an imbalance Trump has targeted in the past and one of the few issues that puts him in agreement with lawmakers like Sen. Bernie Sanders. 'Tariffs will exacerbate that problem,' said Merith Basey, executive director of the advocacy group Patients for Affordable Drugs. 'Prescription drugs aren't luxury goods; they're essential to people's health and survival.' Political and public scrutiny could stop drugmakers from raising prices precipitously, with one Wall Street analyst even begging the industry in a research note to avoid passing tariffs along in the form of higher drug prices for that reason. Umer Raffat, an analyst with financial firm Evercore ISI, wrote in a March 28 note to clients that he'd heard from multiple CEOs that 'they may have to pass on some of the impact as a price increase.' 'There is already a price discrepancy on many drugs between US vs Europe,' Raffat wrote. 'Raising prices in US will add more fire to this burning issue,' potentially backfiring 'in a big way' by accelerating conversations in Washington about bringing back a plan from Trump's first administration to tie US prices to those paid in other similar countries, known as the 'most favored nation' policy. And even as drug shortages may worsen and prices increase in the nearer term, experts are skeptical that tariffs would achieve their main stated goal of bringing drug manufacturing back to the US. 'Global supply chains are complex, with pharma among the most,' Evan Seigerman, a pharmaceuticals analyst with financial firm BMO Capital Markets, wrote in a research note. 'It's not as simple as moving where someone screws in little screws to make an iPhone.' Seigerman predicted that most large pharmaceutical companies 'are likely to look at imposed tariffs with the intention of 'running out the clock,' waiting until the end of Trump's presidency to consider more permanent manufacturing decisions.' Still, some major US pharmaceutical companies have made large investments in domestic manufacturing recently. Eli Lilly said in February that it would invest an additional $27 billion to build four manufacturing plants in the US, with the potential for tariffs in mind. The company said it anticipates that the plants could start making medicines within five years. 'We're trying to do this quickly, because I think there will be constraints in everything from supply chain of building materials to energy,' Lilly's CEO, David Ricks, told CNN at the time. Ricks also said the plan to build so many new domestic plants relies on renewal of certain favorable tax provisions for the industry. Still, the process of building new plants or establishing new manufacturing sites can take years. And while multiple experts told CNN they agree it's crucial to reduce the nation's reliance on other countries for critical medicines, they questioned whether tariffs are the way to accomplish that. 'We think that's a critical thing for us to explore with the administration over the next several years,' said John Murphy, CEO of the Association for Accessible Medicines, which represents generic drug manufacturers. 'That's a long-term proposal, right? We can't build that infrastructure overnight, but we can lose access to a number of drugs overnight, if we're not careful.'
CNN
09-04-2025
- Business
- CNN
Trump drug tariffs would drive up prices, worsen shortages before any boost to US manufacturing, experts warn
'Major' tariffs on pharmaceutical imports are coming soon, President Donald Trump says, pledging that they'd help bring drug manufacturing back to the US while lamenting that other countries pay much lower prices for the same medicines. Instead, patient advocates and drug supply chain experts warn, tariffs are likely to drive the price of medicines higher and exacerbate already dangerous drug shortages. Whether they influence manufacturers to make more drugs in the US is a source of debate, and any increase in production is at least several years away. 'We're going to be announcing very shortly a major tariff on pharmaceuticals,' Trump said Tuesday at the National Republican Congressional Committee dinner, although he didn't specify the size of the tariff or when it would be implemented. Medicines had been exempted from the president's 'Liberation Day' tariff announcement April 2, causing the industry to breathe a brief sigh of relief. The president had also exempted the industry from the tariffs he imposed in his first term. In his tariffs speech last week, Trump said it was a 'tremendous problem' that 'the United States can no longer produce enough antibiotics to treat our sick.' That problem may get worse if tariffs come into play, experts warned while agreeing that it's a problem that needs fixing. The impacts of tariffs could be largest for generic drugs, which make up about 90% of the medicines prescribed in the US and many of which rely on ingredients made in China and India. Generic drugs, whether they're antibiotics, diabetes drugs or statins to lower cholesterol, sell for 'pennies per dose,' said Tom Kraus, vice president of government relations for the American Society of Health-System Pharmacists. Increasing the cost of ingredients that go into them 'can make it so that it's no longer profitable to sell that drug in the United States.' Already, shortages of antibiotics are a major problem in the US. Antimicrobials are among the most common drugs to be in short supply, with 40 active shortages in the US as of the end of 2024, according to data from the American Society of Health-System Pharmacists. Antibiotics currently in shortage include amoxicillin, commonly used for strep throat and ear infections, and Bicillin, crucial for treating syphilis infections. Other especially precarious medicines include sterile injectable drugs used in hospitals. Those can be products as simple as IV saline bags or injectable dextrose, used in emergency settings, as well as cancer chemotherapy drugs. They're required to be manufactured under pristine conditions and have been in shortage for years because of low prices and market disruptions. 'Added costs to already low-margin products may be a tipping point for companies to discontinue production,' said Erin Fox, a drug shortages expert at University of Utah Health. 'I'm worried we'll see discontinuation and a less resilient supply chain if companies quit making essential products.' An estimated 40% of generic drugs have only one or two suppliers making their ingredients, said Rena Conti, an associate professor at the Boston University Questrom School of Business. 'That's a pretty fragile supply,' Conti said. 'If one of those manufacturers exits, well, then we're a little bit in a pickle' – causing challenges for pharmacies and hospitals in stocking the drugs in the coming months. Consumers, meanwhile, could have trouble finding the medications they need when they go to the drugstore. And when one manufacturer is the sole supplier of a medicine, prices often rise. That can sometimes be astronomical, even for generic medicines – such as when Martin Shkreli, known as the Pharma Bro, raised the price of a medicine used by people with HIV from $13.50 to $750 overnight. Public and political pressure has made moves like that less common, but they still occur. But for many generic medicines, especially sterile injectables, it may be difficult for manufacturers to pass along price increases, said Dr. Marta Wosińska, a senior fellow at the Brookings Center on Health Policy. 'One reason is immediate – group purchasing organization (GPO) contracts,' Wosińska wrote in an article analyzing the potential effects of tariffs. 'All hospitals use GPOs to contract for sterile injectable generics used in inpatient settings, with those contracts locking in prices but not quantity.' Those contracts generally last one to three years, she noted, 'and may limit price increases.' Moreover, 'there are laws that make increasing prices faster than inflation a problem for a drug company,' said David Maris, a managing partner at Phalanx Investment Partners who spent years as a financial analyst following the drug industry. 'So I am not sure how they would even be able to pass along the increase.' For branded medicines – those that still have patent protection and don't face cheaper generic copycat competition – it could be a different story, Maris said. There, it would be tariffs from Europe that could hit hardest, with a huge amount of drug manufacturing in countries including Ireland, which has a favorable tax environment. Ingredients for a branded drug may make up only 10% of the total cost to produce a product, Maris estimated, 'so if that 10% rises by 35%, the overall impact on production costs is relatively small.' Unlike with generic medicines, makers of branded drugs have more cushion to absorb price increases, Maris pointed out. But he doesn't think they will. 'These costs will be passed on, leading to higher drug prices,' he said. 'For consumers with insurance, that likely means higher premiums and potentially higher out-of-pocket copays.' Already, the US pays the highest prices for drugs in the world, an imbalance Trump has targeted in the past and one of the few issues that puts him in agreement with lawmakers like Sen. Bernie Sanders. 'Tariffs will exacerbate that problem,' said Merith Basey, executive director of the advocacy group Patients for Affordable Drugs. 'Prescription drugs aren't luxury goods; they're essential to people's health and survival.' Political and public scrutiny could stop drugmakers from raising prices precipitously, with one Wall Street analyst even begging the industry in a research note to avoid passing tariffs along in the form of higher drug prices for that reason. Umer Raffat, an analyst with financial firm Evercore ISI, wrote in a March 28 note to clients that he'd heard from multiple CEOs that 'they may have to pass on some of the impact as a price increase.' 'There is already a price discrepancy on many drugs between US vs Europe,' Raffat wrote. 'Raising prices in US will add more fire to this burning issue,' potentially backfiring 'in a big way' by accelerating conversations in Washington about bringing back a plan from Trump's first administration to tie US prices to those paid in other similar countries, known as the 'most favored nation' policy. And even as drug shortages may worsen and prices increase in the nearer term, experts are skeptical that tariffs would achieve their main stated goal of bringing drug manufacturing back to the US. 'Global supply chains are complex, with pharma among the most,' Evan Seigerman, a pharmaceuticals analyst with financial firm BMO Capital Markets, wrote in a research note. 'It's not as simple as moving where someone screws in little screws to make an iPhone.' Seigerman predicted that most large pharmaceutical companies 'are likely to look at imposed tariffs with the intention of 'running out the clock,' waiting until the end of Trump's presidency to consider more permanent manufacturing decisions.' Still, some major US pharmaceutical companies have made large investments in domestic manufacturing recently. Eli Lilly said in February that it would invest an additional $27 billion to build four manufacturing plants in the US, with the potential for tariffs in mind. The company said it anticipates that the plants could start making medicines within five years. 'We're trying to do this quickly, because I think there will be constraints in everything from supply chain of building materials to energy,' Lilly's CEO, David Ricks, told CNN at the time. Ricks also said the plan to build so many new domestic plants relies on renewal of certain favorable tax provisions for the industry. Still, the process of building new plants or establishing new manufacturing sites can take years. And while multiple experts told CNN they agree it's crucial to reduce the nation's reliance on other countries for critical medicines, they questioned whether tariffs are the way to accomplish that. 'We think that's a critical thing for us to explore with the administration over the next several years,' said John Murphy, CEO of the Association for Accessible Medicines, which represents generic drug manufacturers. 'That's a long-term proposal, right? We can't build that infrastructure overnight, but we can lose access to a number of drugs overnight, if we're not careful.'
CNN
09-04-2025
- Business
- CNN
Trump drug tariffs would drive up prices, worsen shortages before any boost to US manufacturing, experts warn
'Major' tariffs on pharmaceutical imports are coming soon, President Donald Trump says, pledging that they'd help bring drug manufacturing back to the US while lamenting that other countries pay much lower prices for the same medicines. Instead, patient advocates and drug supply chain experts warn, tariffs are likely to drive the price of medicines higher and exacerbate already dangerous drug shortages. Whether they influence manufacturers to make more drugs in the US is a source of debate, and any increase in production is at least several years away. 'We're going to be announcing very shortly a major tariff on pharmaceuticals,' Trump said Tuesday at the National Republican Congressional Committee dinner, although he didn't specify the size of the tariff or when it would be implemented. Medicines had been exempted from the president's 'Liberation Day' tariff announcement April 2, causing the industry to breathe a brief sigh of relief. The president had also exempted the industry from the tariffs he imposed in his first term. In his tariffs speech last week, Trump said it was a 'tremendous problem' that 'the United States can no longer produce enough antibiotics to treat our sick.' That problem may get worse if tariffs come into play, experts warned while agreeing that it's a problem that needs fixing. The impacts of tariffs could be largest for generic drugs, which make up about 90% of the medicines prescribed in the US and many of which rely on ingredients made in China and India. Generic drugs, whether they're antibiotics, diabetes drugs or statins to lower cholesterol, sell for 'pennies per dose,' said Tom Kraus, vice president of government relations for the American Society of Health-System Pharmacists. Increasing the cost of ingredients that go into them 'can make it so that it's no longer profitable to sell that drug in the United States.' Already, shortages of antibiotics are a major problem in the US. Antimicrobials are among the most common drugs to be in short supply, with 40 active shortages in the US as of the end of 2024, according to data from the American Society of Health-System Pharmacists. Antibiotics currently in shortage include amoxicillin, commonly used for strep throat and ear infections, and Bicillin, crucial for treating syphilis infections. Other especially precarious medicines include sterile injectable drugs used in hospitals. Those can be products as simple as IV saline bags or injectable dextrose, used in emergency settings, as well as cancer chemotherapy drugs. They're required to be manufactured under pristine conditions and have been in shortage for years because of low prices and market disruptions. 'Added costs to already low-margin products may be a tipping point for companies to discontinue production,' said Erin Fox, a drug shortages expert at University of Utah Health. 'I'm worried we'll see discontinuation and a less resilient supply chain if companies quit making essential products.' An estimated 40% of generic drugs have only one or two suppliers making their ingredients, said Rena Conti, an associate professor at the Boston University Questrom School of Business. 'That's a pretty fragile supply,' Conti said. 'If one of those manufacturers exits, well, then we're a little bit in a pickle' – causing challenges for pharmacies and hospitals in stocking the drugs in the coming months. Consumers, meanwhile, could have trouble finding the medications they need when they go to the drugstore. And when one manufacturer is the sole supplier of a medicine, prices often rise. That can sometimes be astronomical, even for generic medicines – such as when Martin Shkreli, known as the Pharma Bro, raised the price of a medicine used by people with HIV from $13.50 to $750 overnight. Public and political pressure has made moves like that less common, but they still occur. But for many generic medicines, especially sterile injectables, it may be difficult for manufacturers to pass along price increases, said Dr. Marta Wosińska, a senior fellow at the Brookings Center on Health Policy. 'One reason is immediate – group purchasing organization (GPO) contracts,' Wosińska wrote in an article analyzing the potential effects of tariffs. 'All hospitals use GPOs to contract for sterile injectable generics used in inpatient settings, with those contracts locking in prices but not quantity.' Those contracts generally last one to three years, she noted, 'and may limit price increases.' Moreover, 'there are laws that make increasing prices faster than inflation a problem for a drug company,' said David Maris, a managing partner at Phalanx Investment Partners who spent years as a financial analyst following the drug industry. 'So I am not sure how they would even be able to pass along the increase.' For branded medicines – those that still have patent protection and don't face cheaper generic copycat competition – it could be a different story, Maris said. There, it would be tariffs from Europe that could hit hardest, with a huge amount of drug manufacturing in countries including Ireland, which has a favorable tax environment. Ingredients for a branded drug may make up only 10% of the total cost to produce a product, Maris estimated, 'so if that 10% rises by 35%, the overall impact on production costs is relatively small.' Unlike with generic medicines, makers of branded drugs have more cushion to absorb price increases, Maris pointed out. But he doesn't think they will. 'These costs will be passed on, leading to higher drug prices,' he said. 'For consumers with insurance, that likely means higher premiums and potentially higher out-of-pocket copays.' Already, the US pays the highest prices for drugs in the world, an imbalance Trump has targeted in the past and one of the few issues that puts him in agreement with lawmakers like Sen. Bernie Sanders. 'Tariffs will exacerbate that problem,' said Merith Basey, executive director of the advocacy group Patients for Affordable Drugs. 'Prescription drugs aren't luxury goods; they're essential to people's health and survival.' Political and public scrutiny could stop drugmakers from raising prices precipitously, with one Wall Street analyst even begging the industry in a research note to avoid passing tariffs along in the form of higher drug prices for that reason. Umer Raffat, an analyst with financial firm Evercore ISI, wrote in a March 28 note to clients that he'd heard from multiple CEOs that 'they may have to pass on some of the impact as a price increase.' 'There is already a price discrepancy on many drugs between US vs Europe,' Raffat wrote. 'Raising prices in US will add more fire to this burning issue,' potentially backfiring 'in a big way' by accelerating conversations in Washington about bringing back a plan from Trump's first administration to tie US prices to those paid in other similar countries, known as the 'most favored nation' policy. And even as drug shortages may worsen and prices increase in the nearer term, experts are skeptical that tariffs would achieve their main stated goal of bringing drug manufacturing back to the US. 'Global supply chains are complex, with pharma among the most,' Evan Seigerman, a pharmaceuticals analyst with financial firm BMO Capital Markets, wrote in a research note. 'It's not as simple as moving where someone screws in little screws to make an iPhone.' Seigerman predicted that most large pharmaceutical companies 'are likely to look at imposed tariffs with the intention of 'running out the clock,' waiting until the end of Trump's presidency to consider more permanent manufacturing decisions.' Still, some major US pharmaceutical companies have made large investments in domestic manufacturing recently. Eli Lilly said in February that it would invest an additional $27 billion to build four manufacturing plants in the US, with the potential for tariffs in mind. The company said it anticipates that the plants could start making medicines within five years. 'We're trying to do this quickly, because I think there will be constraints in everything from supply chain of building materials to energy,' Lilly's CEO, David Ricks, told CNN at the time. Ricks also said the plan to build so many new domestic plants relies on renewal of certain favorable tax provisions for the industry. Still, the process of building new plants or establishing new manufacturing sites can take years. And while multiple experts told CNN they agree it's crucial to reduce the nation's reliance on other countries for critical medicines, they questioned whether tariffs are the way to accomplish that. 'We think that's a critical thing for us to explore with the administration over the next several years,' said John Murphy, CEO of the Association for Accessible Medicines, which represents generic drug manufacturers. 'That's a long-term proposal, right? We can't build that infrastructure overnight, but we can lose access to a number of drugs overnight, if we're not careful.'
