Hospitals across the country felt it when Acorn Pharmaceuticals closed in February.
A pharmaceutical company based in Lake Forest, Illinois was responsible for manufacturing. 75 generic drugs, they were all pulled from the market when the company closed. In some cases, the company was the sole supplier of certain products.
The closure comes amid and contributes to the ongoing drug shortage crisis in the United States. Acorn’s bankruptcy and subsequent closure is part of a larger disaster caused by fewer manufacturers producing cheaper generic drugs in the U.S., leaving the rest of the companies with poorer and more profitable profits. is. Complicated global supply chains could have patients competing for life-saving drugs for months and even years to come.
New drug shortages increased by nearly 30% from 2021 to 2022, affecting 295 products as of the end of last year, according to the report. March report From the Senate Homeland Security and Government Affairs Committee. Drug shortages are affecting cancer patients who desperately need chemotherapy drugs, as well as people in intensive care units and emergency rooms who need certain generic IV drugs that are in tight supply.
The shortage is getting worse. There were more than 300 drug shortages as of June, the most in nearly a decade, according to the American Society of Health System Pharmacists, an organization that tracks drug shortages.
Why is this happening now?
Drug shortages are nothing new. In recent years, supply shortages of heart disease drugs, cancer drugs, and ADHD drugs have occurred in the United States and around the world. Generic drug supplies are particularly vulnerable. Companies like Acorn are facing fierce competition and declining profits, forcing them to lay off workers and cut costs in order to stay in business.
Valerie Jensen, associate director of the Food and Drug Administration’s drug shortage program, said the Acorn shutdown has left the U.S. with a “substantial chunk” of manufacturing capacity, while other generic drug makers are struggling to stay in business. said.
“When you see a company like Acorn shut down, it’s very worrying for us because we lose that ability,” Jensen said. “And we have to work closely with other companies to make up for that shortfall. So this is definitely a concern and we will continue to monitor it closely.”
Former Acorn CEO Douglas Booth did not respond to a request for comment. Acorn’s media representative did not respond to an email.
Americans rely heavily on generics, and according to prescriptions, generics make up about 90% of all prescriptions. Accessible Medicines Associationan industry association representing generic drug manufacturers.
At the same time, generic drugs, sold at very low prices, represent only about 20% of US drug spending. Despite high demand for their products, generic drug makers are not making much money due to the low cost of drugs. said AAM interim president and CEO David Goh.
Over the past decade, the number of generic drugs manufactured in the United States has declined.a working paper A study by the National Economic Research Service, a nonprofit, nonpartisan research group based in Cambridge, Massachusetts, found that from 2013 to 2019, the number of U.S. facilities registered to manufacture drug substances was It decreased by about 10% to 118. In 2014, the number did not decline, according to the report.
When Akorn subsequently shuts down filed for bankruptcyThe company was one of two US suppliers of liquid albuterol, an essential drug used by hospitals to treat childhood asthma and respiratory syncytial virus.
Mohamed Kabir, who was director of formulation development at Acorn before the company closed, said it was one of the company’s most in-demand products.
“It was a big surprise,” Kabir said of Acorn’s closure.
The company was founded in 1971 as a manufacturer of eye care products and has expanded into manufacturing a variety of pharmaceuticals including antibiotics, pain relievers, allergy medicines and veterinary medicines. The company’s generic drugs included adenosine, an arrhythmia treatment, and lorazepam, which is used for anxiety, nausea and vomiting in some cancer patients. The company was the sole supplier of physostigmine, an antidote for certain drug overdoses. according to report A statement from the End Drug Shortages Alliance, an organization dedicated to preventing drug shortages.
In the wake of Acorn’s shutdown, all of Acorn’s drugs are either in short supply or face supply problems, according to the American Health System Pharmacists Association. It is said that there is
To make matters worse, Akorn’s shutdown left it unable to monitor the quality and safety of many of the drugs it already sold online to retailers, health care facilities and consumers nationwide. In early May FDA announced What Acorn Remembered About Drugs had been distributed.
At the Mayo Clinic, pharmacists scrambled to switch suppliers and find ways to get drugs made only by Acorn. The clinic also had to dispose of any remaining Akorn products of his and notify doctors and patients of the recall.
“This is definitely a difficult situation,” said Eric Tichy, director of pharmacy supply solutions at the Mayo Clinic in Rochester, Minnesota, and president of the Alliance to End Drug Shortages. “This experience led to further work for our team and patient anxiety.”
Generic Drug Shortage Could Get Worse
Once the drug’s patent expires, the generic drug is allowed to be marketed, often at a lower price than the branded drug.
“The fundamental question is the economics of the system,” said FDA Commissioner Robert Calif. Aspen Ideas Festival in late June. Unlike branded drug makers, generic drug makers aren’t protected by patents that allow them to sell drugs exclusively for a period of time, he said. For generic drug manufacturing to grow in the United States, companies need to be paid enough to make drugs and stay in business.
The problems facing the industry today are likely to get worse as more US companies go bankrupt.
Lannett, Inc. is a generic drug manufacturer in Pennsylvania. announced The company filed for Article 11 bankruptcy protection in May, but plans to continue operations during the restructuring.
Teva Pharmaceuticals, a leading Israel-based generic drug manufacturer, said in a statement In the same month, it cut back on the production of generic drugs. Earlier last year, India-based Aurobindo Pharma announced it would close its U.S. generic drug manufacturing facility in New Jersey.
“It’s become a race to the bottom,” Goh said.
Michael Ganio, senior director of pharmacy practices and quality at the American Association of Health System Pharmacists, said the generic drug industry’s business model has become unsustainable for many manufacturers.
“If you talk to people in the generics industry, they’ll tell you about one-third are profitable, one-third are break-even, and one-third are losing money,” he said. .
The United States is already highly dependent on foreign pharmaceutical companies. According to the FDA, in 2021, 78% of drug substance suppliers were in China, India and the European Union. The closure of Acorn will make the U.S. even more dependent on foreign manufacturing.
Foreign suppliers do not always meet strict FDA standards for generic drugs. In addition, visits to FDA’s foreign facilities are often pre-announced and researchers are notified. may rely on facilities To provide translation services, concerns have arisen as to whether the agency has all the information necessary to accurately assess the quality of its products.
“Offshore production in China and India outpaces all but a few North American manufacturing plants,” said David Goetler, a former FDA science policy adviser and FDA oversight expert. “Unfortunately, lower prices generally mean lower quality.”
India-based generic drug maker Intus Pharmaceuticals suspended production in December following an accident. FDA inspections last year raised numerous quality concerns. The outage caused widespread shortages of the chemotherapy drug cisplatin, which is used in a variety of cancers including testicular, lung, bladder, cervical and ovarian cancer.
Global Pharma, also based in India, recalled its artificial tears Ezricare eye drops earlier this year after four people died from a drug-resistant bacterial infection.Ann FDA inspection revealed The company failed to follow proper procedures to prevent product contamination.
Intus Pharmaceuticals and Global Pharma did not respond to requests for comment.
The move to expand pharmaceutical manufacturing abroad is a “huge national security issue,” said Caliph, especially given the current international conflict situation.
What can you do?
There is no quick fix. Erin Fox, a pharmacist and professor of pharmacy at the University of Utah, said pharmaceutical companies don’t need to disclose exactly which suppliers make which products or where they are located. This means that it is very difficult for the FDA to know which products are manufactured abroad.
“The problem is that we don’t know what’s coming from where and how much,” Ganio said. “It’s not easy to access.”
and report In a June announcement, the Accessible Medicines Association’s policy team outlined several steps the U.S. government can take to help keep domestic generic drug makers viable.
These included creating incentives for hospitals to purchase generic drug supplies at fixed prices for multiple years, providing an ongoing revenue stream for generic drug manufacturers. The government may also provide subsidies to generic drug manufacturers to enable them to upgrade their manufacturing facilities or build new facilities that can provide additional capacity.
This action included covering and encouraging the use of new generic drugs in the Medicare Drug Plan.
Generic drug manufacturing is a very complex and highly regulated industry, so it won’t be easy for new manufacturers to enter quickly, Tichy said.
In other words, patients who need medicine will live without it.
“The market is already tight in supply,” Tichy said. “How do we communicate that to our patients?
