Thousands of patients face delays getting treatments for cancer and other life-threatening diseases, as drug shortages in the United States approach record levels.
Hospitals scour shelves for supplies of medication to reverse lead poisoning and sterile fluid needed to stop the heart for bypass surgery. Some antibiotics are still scarce in the aftermath of the winter flu season when doctors and patients frantically chased medications to treat ailments like strep throat. Even Children’s Tylenol was hard to find.
Hundreds of drugs are on the drug list in short supply in the United States, as officials grapple with opaque and sometimes disruptive supply chain, quality and financial issues leading to manufacturing shutdowns.
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The shortage is so severe that it’s capturing the attention of the White House and Congress, which are examining the reasons behind the faltering generic drug market, which accounts for about 90% of domestic prescriptions.
The Biden administration has assembled a team to find long-term solutions to support the drug supply chain, at a time when the United States is still heavily dependent on drugs and drug ingredients from India and China. And in recent weeks, generic drug makers, supply chain experts and patient advocates have appeared before lawmakers to discuss the problems.
The scarcity of generic forms of chemotherapy for lung, breast, bladder, and ovarian cancers has heightened concerns.
“This is, in my view, a public health emergency,” said Dr. Amanda Fader, a professor at Johns Hopkins University School of Medicine and president-elect of the Society of Gynecologic Oncology, “because of the breadth of individual affects and the number of chemotherapy agents that are currently in short supply.”
The American Cancer Society warned last week that a delay caused by a deficiency could lead to worse outcomes for patients.
“If these drugs are not available, people will receive inferior care,” said Dr. William Dahut, the association’s chief medical officer. “That’s the whole point. These are not third- or fourth-line drugs where there are so many other factors. They are used in advance of the people you’re trying to treat.”
Ryan Dowers beat pancreatic cancer in 2021, but late last year a scan showed cancerous spots on his liver. Doares, 39, a father of two, had hoped to receive his last four doses of chemotherapy in April.
Then his doctor delivered amazing news: He didn’t cut back on those he prioritized treatment.
“The light at the end of the tunnel was within sight,” said Doars, a special education teacher in Iowa City. “It got worse being so close – and now this.”
Laura Bray, who founded a nonprofit called Angels for Change, serves as a liaison between patients, health systems, and drug companies to “micro source,” as she calls it, hard-to-find medicines.
“Will we have the resolve and sense of urgency to fix this?” asked Bray, an associate business professor who has been providing information to the White House and Congress. “It’s possible. It can be done. It’s happening in other supply chains. But we’ve got to focus on it and we’ve got to think about ending it – rather than mitigating it. I think the jury isn’t sure on that.”
For Duaris, Bray contacted the maker of cisplatin, the chemical drug he needed, and arranged for a supply to be sent within days and to others at his hospital. Some weren’t so lucky, encountering frightening gaps between treatments.
According to James McKinney, a spokesman for the Food and Drug Administration, the White House team working on the broader issue of the longstanding drug supply collapse includes national security, economic and health officials. Bloomberg reported earlier about the White House’s involvement.
Officials have been discussing possible measures such as tax incentives for generic drug manufacturers and increasing transparency about the quality of generic drugs. Current incentives favor lower-priced drug makers, which include ones that might cut corners — shutting down a crippled factory if the FDA orders a solution. (Some shortages, such as weight-loss drugs, are the result of very high demand, while others are attributed to overprescribing, including antibiotics, or a lack of investment in potential alternatives.)
The Food and Drug Administration, which employs a team of about 10 people who do the day-to-day work of mitigating and reporting drug shortages, said it is seeking congressional authorization for additional information about the drug’s manufacturing and supply chain.
But the agency has also expressed concerns to the White House about severe financial pressures in the generic drug industry — an economic problem that FDA officials say they are ill-suited to address.
FDA Commissioner Dr. Robert Calif highlighted the agency’s views during recent appearances before Congress, saying officials can only fill so many loopholes.
“We have to fix the core of the economy if we’re going to fix this situation,” Kalev told a House of Representatives committee on Thursday.
David Gu, interim CEO of the Accessible Drugs Association, which represents generic drug companies, warned FDA officials at an April meeting that the bankruptcy and recent closure of Akorn Pharmaceuticals was likely to be followed by others.
“The shortage is on the rise. We’ve all seen it,” Gu said in an interview. “And it’s likely to get worse, not better, very soon.”
Gu cited data that confirmed the pressure facing the general industry. Despite the increase in the number of generic drug makers, a review by IQVIA, a healthcare analytics company, showed that the market had consolidated so that three buyers accounted for about 90% of generic drug purchases. The brokers bring together major drug distributors and retail chains, such as Red Oak Sourcing, which includes CVS Health and Cardinal Health, and ClarusONE, which includes Walmart and McKesson. Greens also has distribution agreements with AmerisourceBergen. The companies did not respond to requests for comment.
Competition for contracts with these middlemen pits American manufacturers against those in India, where labor costs are much lower. When a generic drug company can’t get a contract for a drug, it tends to stop making it and may actually see its meager profits shrink.
“The chance of getting it wrong is much narrower if you’re a general manufacturer,” Gu said.
Hospital pharmacists and supply chain experts were stunned in February by the abrupt closure of Akorn, whose products were then recalled because there was no staff left to address potential quality concerns.
It added “insult to injury,” said Eric Tichy, chief of supply chain at the Mayo Clinic and chairman of the End Drug Shortages Alliance.
Acorn has produced nearly 100 medications, including cylinders of albuterol that children’s hospitals have relied on to relieve their breathing difficulties. It is the only company that has made an antidote for lead poisoning, Tichy said.
“Health is the basis for our country to do well,” said Tichy. “And then we have a local factory that falls apart and there isn’t much action.”
Four pending bipartisan Senate bills could help get generics to market more quickly by addressing tactics or loopholes that cause delays. During a House hearing on shortages Thursday, Anthony Sardella, a business research consultant at Washington University in St. Louis, said generic drug prices have fallen about 50% since 2016.
“But there is a high cost to lower prices,” Sardella said, noting that they may lead to cost-cutting that can lead to quality problems.
A recent example is Intas Pharmaceuticals, a company in India that makes three hard-to-find staple chemotherapy drugs: methotrexate, carboplatin, and cisplatin, the Dwars’ sought-after drug. Intas has temporarily stopped manufacturing the drugs after the Food and Drug Administration found serious quality control violations.
During an unannounced visit to the Intas plant, FDA inspectors discovered a “truckload” of hundreds of plastic bags filled with shredded and shredded documents, according to a December report. The report said a quality control worker doused acid on shredded records and stuffed them in a garbage bag.
The report said FDA inspectors pieced together the paperwork and found quality control records for products destined for the United States. The agency cited a wide range of other problems as well.
To ease supply disruptions, Intas’ US distributor, Accord Pharmaceuticals, said a handful of the pieces have been third-party tested, approved and released to the US market. Among the treatments Bray arranged that reached patients in Iowa.
The companies are working with the Food and Drug Administration to reinstate manufacture for US customers, said a statement from Accord.
The Society of Gynecological Oncology sent out a national survey in recent weeks. In response, doctors in 35 states said they had few if any supply of key chemotherapy drugs, even at large cancer centers and teaching hospitals.
Dr. Patrick Timmins, a partner with Women’s Cancer Care in Albany, New York, said his practice ran out of some chemotherapy drugs last week, but 25 patients still need them.
“Our patients are at war, and what we’re doing is taking their weapons away,” Timmins said. “It’s absolutely ridiculous that we can’t find a way, at least in the short term, to treat our patients, and in the long term to solve these recurring problems.”
When Bray met with White House staff in late April, she said she recommended creating an exchange, to get drugs where they’re needed most, and to ramp up production of the small drug, often referred to as compound.
Dr. Kevin Schulman, a Stanford University professor of medicine who has studied the generic drug industry, said he urged the White House team to examine how aggressively the middlemen are at contracting with generic companies. They charge very low prices, he said, but unlike a customer-facing company like Apple that contracts with suppliers around the world, drug brokers face no accountability when shortages occur.
Schulman said he recommended expanding government contracting with the nonprofit organization Civica, which sells generics at slightly inflated prices, and which could help generic makers run a stable business.
“The brokers are driving people out of the market,” Schulman said. “I think it’s a market problem and we need market-level solutions.”
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