Its Illinois facility was licensed to make liquid albuterol, which is used by hospitals for nebulizers, common devices that turn medicine into mist to be inhaled. The shutdown of that plant leaves just one remaining domestic supplier of liquid albuterol, supply chain analysts and executives said, although another pharmacy supplier is racing to build a second supply.
The FDA has had the medicine on its shortage list since last fall. Hospitals have been able to manage the issue thus far and patients have not been affected directly, as they were when the coronavirus caused a shortage of asthma inhalers in 2020.
Yet health system leaders say it is another example of the fragile domestic supply of vital generic drugs, a problem that was exacerbated by the pandemic and continues in multiple types of medicines. Profit margins are so low on some generic drugs that they have few manufacturers, so a single failure can have a big impact on the health system, experts say.
Akorn had not been shipping its 20-millilter bottles of liquid albuterol for several months, said Premier, a major group purchasing company for hospitals. Now the closure threatens to prolong those shortages in 2023, Premier officials said.
In general, it shows that the potential problem when the market for a vital product is highly concentrated, said Soumi Saha, senior vice president for government affairs at Premier.
“A sole manufacturer, whether or not it’s domestic, is still a sole manufacturer and creates immense risk” that a disruption could wipe out supply, she said. “The downstream effects are the same as if the manufacturer were foreign.”
The shortages last year were exacerbated by outbreaks of the coronavirus and RSV. Children’s hospitals had already been deploying workarounds, hunting for supplies and modifying doses of albuterol in their own pharmacies to suit their needs, a process called compounding. Wholesalers have barred hospitals from ordering more than their usual supply of liquid albuterol to avoid stocking up and hoarding, Premier said.
At Nemours Children’s Hospital in Orlando, Angela Folger, the director of pharmacy, said the absence of 20-milliliter bottles of albuterol for use in nebulizers has forced staff to squeeze out the contents of 40 tiny 0.5 ml containers, which the hospital can still purchase, to make a single batch. It’s time-consuming and labor intensive, Folger said, but ultimately they have been able to find enough.
The hospital has been grappling with a variety of generic drug shortages, which reached a peak during the pandemic and have continued to linger, she said.
“This is the worst it’s ever been in my almost 20-year career,” Folger said.
Akorn had been hampered by manufacturing violations detected in FDA inspections at its plants in 2018 in Illinois and New Jersey, according to public records. Those types of negative inspection results are often signs of financial distress, said Erin Fox, an expert on pharmaceutical supply and shortages at University of Utah Health.
“We see companies perhaps no longer able to invest in the quality of their facilities,” Fox said. “That is really hard to do if the products you are making are low margin.”
In 2020, as the pandemic took hold around the globe, India and China shut down generic drug exports to conserve their own supplies, creating shortages in the United States. That highlighted the need for more domestic manufacturing. “But Akorn is a factory in Illinois,” Fox said. “Clearly, we need to do more to incentivize and shore up resiliency of the manufacturing that we have, so we don’t see more of these places closed.”
The FDA said it is reviewing drug supplies in light of the Akorn shutdown.
“The FDA is reviewing all drugs affected by this closure and is working with the other manufacturers to understand the supply nationwide. If the approved manufacturers cannot meet market demand, the FDA will add those affected medicines to our Drug Shortage webpage and continue working to resolve or lessen the impact of those shortages using all the tools we have available,” the agency said.
If it determines a shortage exists, the FDA has the authority to expedite approvals for new manufacturing lines, extend expiration dates and hunt for foreign suppliers who can redirect product into the United States.
In the last two months, the Children’s Hospital Association has ramped up an alternative supply of liquid albuterol from a partner supplier, STAQ Pharma, according to the association. Because STAQ is a new producer, the expiration date on its product started at just 32 days, which will require careful planning and frequent deliveries, the association said.
Another domestic supplier of liquid albuterol is Nephron Pharmaceuticals, which operates a facility outside of Columbia, S.C., Premier officials said. Nephron also has been cited by the FDA for manufacturing violations. The State newspaper reported last month that the company furloughed 70 workers.
“We are currently producing Albuterol 0.5 as fast as possible to deliver to the market — and to patients — to address this shortage,” Nephron CEO Lou Kennedy said in an email. He said temporary furloughs have had no impact on production.
Akorn did not respond to a request for comment submitted through its media email address. The company filed under Chapter 11 of the bankruptcy code in May 2020 and trading of its stock was suspended in June of that year.
In U.S. Bankruptcy Court filings, the company said its board of directors voted Feb. 21 to shut down, terminate all employees and liquidate its assets because it did not have enough capital to continue operations. It said it has debts of at least $100 million. A class-action lawsuit filed in bankruptcy court on behalf of former employees states that 900 workers lost their jobs.