Drug shortages are approaching an all-time high, leading to rationing
Thousands of patients are experiencing delays in getting treatments for cancer and other life-threatening illnesses, as drug shortages in the United States approach record levels.
Hospitals are scouring the shelves for stocks of a drug that reverses lead poisoning and a sterile fluid needed to stop the heart for bypass surgery. Some antibiotics are still in short supply after the winter flu season, when doctors and patients frantically hunt for drugs for conditions such as strep throat. Even Tylenol for kids was hard to find.
Hundreds of drugs are on the list of drugs in short supply in the United States, as officials grapple with an opaque and sometimes interrupted supply chain, quality and financial problems leading to production halts.
The shortages are so acute that they are drawing the attention of the White House and Congress, which are investigating the root causes of the faltering generic drug market, which accounts for about 90 percent of domestic prescriptions.
The Biden administration has assembled a team to find long-term solutions to strengthen the pharmaceutical supply chain at a time when the United States remains heavily dependent on drugs and drug ingredients from India and China. And in recent weeks, generic drug manufacturers, supply chain experts and patient advocates have appeared before lawmakers to discuss the issues.
The scarcity of generic chemotherapy drugs to treat lung, breast, bladder and ovarian cancers has only added to the concern.
“This is, in my opinion, a public health emergency,” said Dr. Amanda Fader, a professor at Johns Hopkins School of Medicine and an elected president of the Society of Gynecologic Oncology, “because of the breadth of individuals it affects and the number of chemotherapy drugs that are currently in short supply.”
The American Cancer Society warned last week that delays caused by the shortages could lead to poorer 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 bottom line. These are not third or fourth line drugs where there are multiple other agents around. These are pre-used for people you are trying to heal.
Ryan Dwars defeated pancreatic cancer in 2021, but at the end of last year a scan showed cancerous spots on his liver. Mr Dwars, 39 and a father of two young girls, had hoped to receive his last four doses of chemotherapy in April.
Then his doctor delivered some stunning news: He didn’t make the cut of those given priority for treatment.
“The light at the end of the tunnel was in sight,” said Mr. Dwars, a special education teacher in Iowa City. “It made it even worse to be so close – and now this.”
Laura Bray, who founded a non-profit organization called Angels for Change, works as a liaison between patients, health systems and drug companies to “micro-source” as she calls hard-to-find drugs.
“Will we have the determination and sense of urgency to fix this?” asked Mrs. Bray, an adjunct professor of business administration who has provided information to the White House and Congress. “It’s possible. It can be done. It’s happening in other supply chains. But we need to focus on it and we need to think about ending it – rather than mitigating it. I think the jury is out on that.”
For Mr. Dwars, Mrs. Bray contacted a manufacturer of cisplatin, the chemo drug he needed, and arranged for a supply to be sent within days and for others at his hospital. Some in states across the country have not been so lucky, encountering frightening gaps between treatments.
According to James McKinney, a spokesman for the Food and Drug Administration, the White House team dealing with the broader issue of prolonged interruptions in drug supplies includes national security, economic and health officials. Bloomberg previously reported about the involvement of the White House.
Officials have debated possible measures such as tax incentives for generic drug manufacturers and more transparency around the quality of generic drugs. Current incentives favor drugmakers with the lowest prices, including those potentially cutting back — leading to disruptive plant closures if the FDA demands a fix. (Some shortages, such as those in weight-loss drugs, are the result of skyrocketing demand, while others are attributed to overprescribing, including for antibiotics, or a lack of investment in potential alternatives.)
The FDA, which employs a team of about 10 people who do the day-to-day work of reducing and reporting drug shortages, has said it is seeking Congressional authorization to obtain additional information about drug manufacturing and supply chains.
But the agency has also expressed concern to the White House about the severe financial strain in the generic drug industry — an economic problem that FDA officials say is ill-suited to address.
Dr. Robert Califf, the FDA commissioner, emphasized the agency’s views during recent appearances before Congress, saying officials can only plug so many holes.
“We need to restore the core of the economy if we want to resolve this situation,” said Dr. Califf on May 11 in a House panel.
David Gaugh, the interim director of the Association for Accessible Medicines, which represents generic drug manufacturers, recalled warning FDA officials at an April meeting that the recent bankruptcy and closure of Akorn Pharmaceuticals was likely to be followed.
“The shortages are increasing. We’ve all seen that,” Mr Gaugh said in an interview. “And it’s probably going to get worse, not better, very soon.”
Mr Gaugh cited data underlining the strain on the generic industry. While the number of generic drug manufacturers has increased, a study by IQVIA, a healthcare analytics company, showed that the market has consolidated to the point where three buyers account for about 90 percent of generic drug purchases. The middlemen are combined 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. Walgreens also has distribution agreements with AmerisourceBergen. The companies have not responded to requests for comment.
The competition for contracts with those intermediaries pits US manufacturers against those in India, where labor costs are much lower. When a generic drug manufacturer can’t get a contract on a drug, it tends to stop making it and its already meager profits may shrink.
“The chances of being wrong are much lower if you’re a generic drug manufacturer,” said Mr. Gaugh.
Hospital pharmacists and supply chain experts were stunned in February by the abrupt shutdown of Akorn, whose products were subsequently recalled because it lacked staff to deal with potential quality issues.
That added “an insult to injury,” said Eric Tichy, president of the Mayo Clinic’s supply chain division and the board chair of the End Drug Shortages Alliance.
Akorn made about 100 drugs, including cylinders of albuterol that children’s hospitals relied on to relieve their breathing problems. And it was the only company making an antidote for lead poisoning, Dr. Tichy said.
“Health is so fundamental to the proper functioning of our country,” said Dr. Tichy. “And then we have a domestic manufacturer that just goes down and there’s not much action.”
Four Senate bills with bipartisan sponsorship could help get generics to market faster by addressing tactics or loopholes that cause delays. During a house to belong Speaking about the shortages Thursday, Anthony Sardella, a corporate research consultant at Washington University in St. Louis, said generic drug prices have fallen about 50 percent since 2016.
“But there are high costs at low prices,” said Mr Sardella, pointing out that they can lead to cost savings that can lead to quality problems.
A recent example was Intas Pharmaceuticals, a company in India that makes three major chemotherapy drugs that are hard to find: methotrexate, carboplatin, and cisplatin, the drug Mr. Dwars needed. Intas temporarily suspended production of the drugs after the FDA 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 torn and shredded documents, according to released a report in December. A quality controller poured acid over cracked records and placed them in a garbage bag, the report said.
FDA inspectors collected papers and found quality control records for products destined for the United States, the report said. The agency also cited a range of other issues.
To ease the supply disruption, Intas’ US distributor, Accord Pharmaceuticals, said a handful of batches have been third-party tested, certified and released for the US market. The treatments organized by Mrs. Bray that reached patients in Iowa were one of them.
The companies worked with the FDA to resume production for US customers, according to an Accord statement, adding that it considered the fragmentation an “isolated incident.”
The Society of Gynecologic Oncology has released a nationwide survey in recent weeks. In response, doctors in 35 states said they had little to no stock of key chemotherapy drugs, even in major cancer centers and teaching hospitals.
Dr. Patrick Timmins, a partner of Women’s Cancer Care Associates in Albany, NY, said his practice was out of chemotherapy as of May 9, but there are still 25 patients who need them.
“Our patients are at war and what we’re doing is taking their guns,” said Dr. Timmins. “It’s completely ridiculous that we can’t figure out a way, at least in the short term, to get our patients treated and, in the long run, to solve these recurring problems.”
When Ms. Bray met with White House staffers in late April, she said she recommended creating an exchange, getting drugs where they were needed most, and increasing production of small batches of drugs, often compounded mentioned to increase.
Dr. Kevin Schulman, a Stanford Medicine professor who has studied the generic drug industry, said he urged the White House team to investigate how much power the intermediary companies have in contracting with generic drug makers. He said they charge rock-bottom prices, but unlike a customer-facing company like Apple that contracts with suppliers around the world, the middlemen need not be held accountable when shortages arise.
Dr. Schulman said he recommended extensive government contracts with the nonprofit Civica, which sells generic drugs at somewhat inflated prices, which can help generic drug manufacturers run a stable business.
“The middlemen are driving people out of the market,” said Dr. Schulman. “I think it’s a market problem and we need solutions at the market level.”