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Generic drugs are the backbone of medicines prescribed in the U.S.: They account for about 90% of all prescriptions filled, according to the Association for Accessible Medicines, a trade group that represents generic drugmakers. Karoline Leavitt, a spokesperson on Trump’s transition team, declined to say whether Trump planned to grant an exemption on generic drugs. According to the American Society of Health-System Pharmacists, a group that tracks drug shortages, there are 277 active drug shortages in the U.S., half of which have persisted for two or more years. That’s different from generic drugs, which are cheaper and are often sold at close to the cost for which they were made, he said. What concerns Kesselheim the most is that tariffs could cause generic drug prices to skyrocket should more generic drug manufacturers drop out.

Persons: Donald Trump, Trump, Aaron Kesselheim, Janet Woodcock, ” Woodcock, Arthur Caplan, you’ve, ”, drugmakers, Woodcock, Karoline Leavitt, Leavitt, ” Kesselheim, Hurricane Helene, “ Organizations: Harvard Medical School, Association for Accessible Medicines, Food and Drug Administration, NYU Langone Medical, American Society of Health, System, Baxter International Locations: China, U.S, India, New York City, Hurricane, North Carolina, Indonesia, United States

In 2017, Hurricane Maria damaged three IV fluid manufacturing plants in Puerto Rico, also operated by Baxter, which led to a shortage. “Although this particular shortage on these particular IV fluids is not something we’ve encountered,” DeRienzo said. Along with IV fluids, the North Carolina Baxter facility also made specialty fluids, such as peritoneal dialysis fluid as well as irrigation fluids, used to clean wounds. Ganio said those measures won’t solve the ongoing IV fluid shortage problems long term. “The IV fluids are kind of a good example of the chronic shortages,” he said.

Persons: Helene, Erin Fox, ” Fox, Fox, ‘, ” Michael Ganio, ” Ganio, ”, hasn’t, Baxter, Chris DeRienzo, Hurricane Maria, we’ve, ” DeRienzo, Ganio Organizations: Food, Baxter, FDA, University of Utah Health, American Society of Health, System, Braun, ICU, American Hospital Association, Carolina Baxter, of Health, Human Services, HHS Locations: North Carolina, U.S, Saline, Puerto Rico, Carolina, Canada, China, Ireland

The FDA’s announcement on Oct. 2 declaring the shortage over meant that compounding pharmacists had to stop filling tirzepatide prescriptions. Simone Williams, 50, of Spartanburg, S.C was prescribed compounded tirzepatide in June 2023 after her Mounjaro savings card expired. Williams began taking compounded tirzepatide for weight loss last year after her Mounjaro savings card expired. Tirzepatide was on the FDA’s drug shortage list for nearly two years. ‘Peace of mind’Meanwhile, patients and compounding pharmacists are celebrating the FDA decision to allow tirzepatide compounding to continue.

Persons: Lilly’s, Mounjaro, Zepbound, semaglutide, Wegovy, drugmakers, tirzepatide, “, Simone Williams, S.C, Simone Williams Simone Williams, Williams, ” Williams, she’s, I’m, ”, Lilly, Michael Ganio, Ganio, Dr, Christopher McGowan, ” McGowan, ” Lilly, Jared Shapiro, ’ ” Shapiro, Elizabeth Kenly, ” Kenly, Kenly Organizations: Drug Administration, FDA, Association, American Society of Health, System, Outsourcing, Alliance, Pharmacy, APC Locations: Spartanburg, Spartanburg , South Carolina, U.S, Cary , North Carolina, Graham , North Carolina

The move, experts say, isn’t based on medical science but instead on ongoing efforts from anti-abortion advocates to restrict access to abortion medications in states with near-total bans, like Louisiana. During a medication abortion, mifepristone is given first, followed by misoprostol one to two days later. According to the new law, it’s not a crime for a patient to possess the medications if they were prescribed to them. Hospitals don’t need to remove misoprostol from hemorrhage carts, the spokesperson added, or hesitate to administer misoprostol to patients experiencing health emergencies. The testimony “illustrated that easy access to these drugs can be dangerous to pregnant women,” Murrill said in the statement.

Persons: — mifepristone, misoprostol, Jennifer Avegno, ”, Greg Caudill, ” Avegno, “, mifepristone, it’s, Tamika Thomas, Magee, ” Thomas, “ We’re, Avegno, don’t, Liz Murrill, ” Murrill, Roe, Wade, Kaitlyn Joshua, ‘, ’ ” Joshua, Joshua —, —, ” Joshua, Lisa Boothby, ’, ” Boothby, They’ll, Boothby, You’re Organizations: New, New Orleans Health Department, NBC, Louisiana Society of Addiction, Gynecology, Louisiana Department of Health, Louisiana Society of Health, System, Physicians, Louisiana Legislature Locations: Louisiana, New Orleans, America, Baton Rouge

☆ The free version of ChatGPT may provide false answers to questions about drugs, new study finds
▼ + stars: | 2023-12-05 | by ( Sawdah Bhaimiya | ) www.businessinsider.com time to read: +4 min

Long Island University researchers challenged ChatGPT with real drug-related questions in the past year. OpenAI advises users not to use its tools including ChatGPT for medical information. The responses provided a base criteria according to which the answers produced by ChatGPT would be compared with. The researchers found that ChatGPT only provided a satisfactory response in accordance with the criteria to 10 of the 39 questions. For the other 29 questions ChatGPT either didn't directly address the question or provided an incorrect or incomplete answer.

Persons: OpenAI, —, ChatGPT, Sara Grossman, Grossman Organizations: Long Island University, Service, American Society of Health, University's, of Pharmacy, OpenAI, United, Stanford Medical Locations: Long, Anaheim , California, United States

☆ Pfizer restarts production at tornado-hit North Carolina plant, but drug supply will still be affected
▼ + stars: | 2023-09-25 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

In this aerial image, damage is seen at a Pfizer pharmaceutical factory after a tornado hit the facility two days earlier, in Rocky Mount, North Carolina, July 21, 2023. In a statement, Pfizer stressed that it has only made the "first step toward full recovery" of its plant in Rocky Mount, North Carolina. The Rocky Mount plant supplies nearly 8% of all sterile injectable medicines used in U.S. hospitals, including anesthesia, analgesia, therapeutics, anti-infectives and neuromuscular blockers. Pfizer on Monday said it has restarted production of about 13 medicines, which were prioritized based on "patient need and inventory levels." Pfizer said it is also continuing to monitor emergency request orders for certain medicines manufactured at the Rocky Mount plant.

Organizations: Pfizer, American Society of Health Locations: Rocky Mount, North Carolina, U.S

☆ The ADHD drug market is already stretched thin. Now it's facing a back-to-school supply strain
▼ + stars: | 2023-08-26 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +8 min

Ten milligram tablets of the hyperactivity drug, Adderall, made by Shire Plc. Adderall and alternative ADHD medications apart from other drugs are Schedule 2 controlled substances. Production limitationsEnding the shortages of Adderall and other ADHD medications is no easy task. That means increasing the production of one drug could potentially require reducing production — and potentially impacting supply — of another drug, according to Ergun. That includes Aytu BioPharma, which makes an ADHD drug that used to be in shortage.

Persons: Jb Reed, It's, Erin Fox, they've, David Margraf, Margraf, drugmakers, Ozlem Ergun, Ergun, Novartis's, Michael Ganio, ASHP's Ganio, RJ Sangosti, Josh Disbrow, Fox Organizations: Shire Plc, Jb, Bloomberg, Getty, and Drug Administration, CNBC, University of Utah, American Society of Health, System Pharmacists, Centers for Disease Control, University of Minnesota's, Infectious Disease, Northeastern University, Teva Pharmaceuticals, Amneal Pharmaceuticals, Sandoz, Purdue Pharma, Rhodes Pharmaceuticals, Drug, Fox, Pharmacists, Drug Enforcement Administration, MediaNews, Denver, FDA, DEA Locations: U.S, Commerce City , Colorado

☆ Pfizer limits distribution of some drugs from North Carolina plant damaged by tornado
▼ + stars: | 2023-08-04 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

The roof of a Pfizer facility shows heavy damage after a tornado passed the area in Rocky Mount, North Carolina, July 19, 2023. Pfizer is limiting the distribution of some drugs manufactured at its plant in Rocky Mount, North Carolina, after the facility was struck by a tornado last month, the company said in a letter to hospitals late Thursday. The letter listed 12 injection products that Pfizer will only distribute through emergency orders "due to their high medical need," effective "immediately and until further notice." It also includes an injection used to treat metabolic acidosis, or the buildup of excess acid in the body due to ailments like kidney failure. Pfizer said last month that the tornado primarily damaged a warehouse facility, which stored raw materials, packaging supplies and finished medicines waiting for quality assurance.

Persons: Meera Bhavsar, Albert Bourla Organizations: Pfizer, American Society of Health Locations: Rocky Mount, North Carolina

☆ Pfizer says supply of some drugs may be disrupted after NC tornado
▼ + stars: | 2023-07-24 | by ( ) www.reuters.com time to read: +1 min

NEW YORK, July 24 (Reuters) - Drugmaker Pfizer Inc (PFE.N) said over 30 drugs, including injections of painkiller fentanyl and anesthetic lidocaine, may see supply disruption after a tornado destroyed a warehouse at its Rocky Mount, North Carolina, plant last week. The company sent a letter late last week to its hospital customers saying it had identified around 64 different formulations or dosages of those more than 30 drugs produced at the plant that may experience continued or new supply disruptions. The company has placed limits on how much supply of those drugs its customers can buy. It said the list was "based on Pfizer market share and inventory levels of less than 3 months across our Pfizer distribution centers and the wholesale chain." The Rocky Mount plant is one of the largest factories for sterile injectable medicines in the world.

Persons: Albert Bourla, Michael Ganio, Michael Erman, Aurora Ellis Organizations: YORK, Drugmaker Pfizer Inc, Pfizer, American Society of Health, System, Thomson Locations: North Carolina

[1/2] The roof of a Pfizer facility shows heavy damage after a tornado passed the area in Rocky Mount, North Carolina, U.S. July 19, 2023. ABC Affiliate WTVD via REUTERSJuly 21 (Reuters) - Most of the tornado damage at Pfizer Inc's (PFE.N) Rocky Mount, North Carolina plant was to the warehouse and not manufacturing facilities, CEO Albert Bourla said on Friday, easing concerns about long-term drug shortages from the plant. Nonetheless, Bourla told a news conference in Rocky Mount that it will be a monumental task to repair the damage. "We are moving full speed to bring this manufacturing plant into action again," Bourla said, noting that crews were working to restore power to the plant. The Rocky Mount plant is one of the largest factories for sterile injectable medicines in the world.

Persons: Albert Bourla, Bourla, Soumi Saha, Saha, Lisa Mulloy, Erin Fox, David Ljunggren, Michael Erman, Shivani Tanna, Rami Ayyub, Doina Chiacu, Cynthia Osterman, Diane Craft Organizations: Pfizer, ABC, WTVD, REUTERS, Pfizer Inc's, U.S, American Society of Health, System Pharmacists, U.S . Food, Drug Administration, FDA, Premier Inc, University of Utah Health, Thomson Locations: Rocky Mount, North Carolina, U.S, Rocky, Bengaluru

July 21 (Reuters) - Pfizer Inc(PFE.N) CEO Albert Bourla said on Friday that tornado damage this week had almost completely destroyed the drugmaker's warehouse at its Rocky Mount, North Carolina, plant, but that production facilities there do not seem to have suffered damage. "It appears that most of the damage sustained at the site was at our warehouse ... the facilities that are producing, (it) doesn't seem that they have suffered any damage." In the meantime, the company is working to identify alternative manufacturing locations for production around the U.S. Nearly 25% of Pfizer's sterile injectables used in U.S. hospitals are produced there, according to the company's website. "There are so many shortages already," said Erin Fox, senior director of drug information at University of Utah Health.

Persons: Albert Bourla, Bourla, Soumi Saha, Saha, Erin Fox, Lisa Mulloy, David Ljunggren, Michael Erman, Rami Ayyub, Doina Organizations: Pfizer Inc, Engineers, U.S, Products, Premier Inc, American Society of Health, System Pharmacists, Pfizer, University of Utah Health, Thomson Locations: North Carolina, Rocky, U.S

☆ Drug shortages’ effects on cancer research may be felt for years to come
▼ + stars: | 2023-07-20 | by ( Jen Christensen | ) edition.cnn.com time to read: +8 min

But these shortages aren’t just bad for current patients, experts say; their effects on cancer research may be felt for years to come. The National Cancer Institute, the federal government’s main agency for cancer research and training, told CNN that at least 174 of its own trials may be affected by the shortages. Cisplatin and other platinum-based drugs are prescribed for 10% to 20% of all cancer patients, according to the National Cancer Institute. Crucial work on hold“With drug shortages, trials have become almost like an impossible task. “These drug shortages come and go, and there’s no real rhyme or reason, and there seems to be no rhyme or reason in terms of which institutions have shortages.

Persons: Joe Biden, it’s, ’ ”, Shadia Jalal, Indiana University Melvin, Jalal, She’s, they’ve, ” Jalal, “, ”, haven’t, “ We’ve, Mark Fleury, Fleury, you’re, ” Fleury, Dmitry Walker, Merck, We’ve, ” Walker, there’s, Biden, Lawrence Feldman, ” Feldman, Feldman, Dr, Sanjay Gupta, ‘ Organizations: CNN, National Cancer Institute, American Society of Health, Cancer, Indiana University, Bren Simon Comprehensive Cancer Center, Hematology, Oncology, IU School of Medicine, Hoosier Cancer Research Network, Veterans Administration, American Cancer Society Cancer Action Network, American Cancer Society, WVU Medicine, US Food, Pharmacists, National Comprehensive Cancer Network, University of Illinois Medical Center, CNN Health Locations: United States, China, Chicago

☆ Tornado Tears Through Pfizer’s N.C. Site, Threatening Crucial Drug Supplies
▼ + stars: | 2023-07-20 | by ( Christina Jewett | More About Christina Jewett | ) www.nytimes.com time to read: +2 min

It was also unclear how deeply the destruction would exacerbate existing national drug shortages, which have reached a 10-year high in recent months. Hospitals are on high alert because low-cost generic products manufactured at the site, such as the sedative propofol, are already among the most shortage-prone on the market. The tornado ripped through a 16-mile strip of the Rocky Mount area, about 50 miles east of Raleigh, at about 12:30 p.m. on Wednesday. She said Pfizer and the Food and Drug Administration had teams on-site to assess the damage. It also makes vancomycin, an antibiotic administered to fight severe infections, and muscle blockers including succinylcholine, also used in surgery.

Persons: I’m, ”, Michael Ganio, Mittal Sutaria, Sutaria, Vizient Organizations: American Society of Health, Pharmacists, National Weather Service, Pfizer, Food and Drug Administration Locations: Rocky, Raleigh, Vizient

☆ The US military is so worried about generic pills that it reportedly wants to do its own testing to make sure they're safe
▼ + stars: | 2023-06-09 | by ( Lydia Ramsey Pflanzer | Zachary Tracer | ) www.businessinsider.com time to read: +4 min

The US military is planning to independently test the quality of generic drugs, Bloomberg reported. The quality of the US drug supply has come into question amid recalls of medications like metformin. The US military is reportedly planning to take extra steps to test the quality of the generic drugs it buys for servicemembers and their families. Bloomberg reported in May that the White House has assembled a team to tackle shortages and quality issues with generic medications. "I have family who take generic drugs, I take generic drugs," he said, adding, "I don't get concerned and I don't tell them to be concerned."

Persons: Anna Edney, Riley Griffin, Valisure, David Light, Jeremy Kahn, Mike Ganio, ASHP Organizations: Bloomberg, FDA, Morning, servicemembers, Department of Defense, White, DOD, Food and Drug Administration, American Society of Health, System

☆ U.S. seeks new suppliers of highly used cancer drug methotrexate in short supply
▼ + stars: | 2023-06-09 | by ( ) www.cnbc.com time to read: +2 min

The U.S. Food and Drug Administration said on Friday it is seeking new suppliers to ease shortages of methotrexate, one of the most commonly used cancer drugs, building on its push to shore up two other scarce chemotherapy medicines. An FDA spokesperson told Reuters the agency is looking for temporary importation options for the drug, which has been in shortage since March. Methotrexate is an injected drug used to treat a wide variety of cancers ranging from acute lymphoblastic leukemia in children, breast cancer, lung cancer, bone cancers and certain types of head and neck cancers, according to the National Cancer Institute. Last week, the FDA said it was looking for additional temporary suppliers for two other cancer chemotherapies, cisplatin and carboplatin. According to the American Society of Health-System Pharmacists, suppliers with methotrexate injections in shortage or on back order include Accord Healthcare, Fresenius Kabi, Pfizer , Teva and Hikma Pharmaceuticals .

Persons: Methotrexate, cisplatin, China's, Senators Gary Peters, Debbie Stabenow, Fresenius Kabi Organizations: . Food, Drug Administration, FDA, Reuters, National Cancer Institute, Pharmaceutical, U.S, Senators, Intas Pharmaceuticals, Healthcare, American Society of Health, System Pharmacists, Accord Healthcare, Pfizer, Teva, Hikma Pharmaceuticals Locations: United States, India, U.S

On social media, families say they’ve hunted for hours for Tamiflu and the first-line antibiotics amoxicillin and Augmentin. They have one viral illness after another. According to the US Centers for Disease Control and Prevention, more than half of US states have “high” or “very high” respiratory virus activity. As for the antibiotics amoxicillin and Augmentin – a combination of amoxicillin and clavulanate, an agent that helps guard against antibiotic resistance – it’s not entirely clear why demand is so high. Some viral illness, like influenza, can leave the body more vulnerable to secondary bacterial infections that may need treatment with antibiotics.

One of the most commonly used antibiotics in the country, amoxicillin, is in short supply, federal health officials say. The department also listed a shortage for an oral powder. It wasn't immediately clear what prompted the shortage or how long it could last. A spokesman for the FDA previously said a number of factors can cause drug shortages, including manufacturing and quality problems, delays and discontinuations. The American Society of Health-System Pharmacists, which maintains a database of drug shortages, last reported shortages from the companies Monday.

Pharmacies across the United States are reporting shortages of one of the most widely used antibiotics, raising concerns that the medication will be in short supply for the upcoming winter season. Three key amoxicillin manufacturers — Hikma Pharmaceuticals, headquartered in the United Kingdom; Sandoz, based in Switzerland; and Teva Pharmaceutical Industries Ltd., headquartered in Israel — are reporting shortages of the antibiotic, according to the American Society of Health-System Pharmacists, which maintains a database of drug shortages. Because amoxicillin is an antibiotic, it is not used to treat infections caused by viruses, such as Covid, the flu or RSV (respiratory syncytial virus). Pharmacists said they are worried if the shortage lingers through the winter, when infections can surge and antibiotic use typically increases. “However, there are a number of factors that can cause or contribute to drug shortages that are out of the FDA’s control.

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