Thousands of patients are facing delays in getting treatment for cancer and other life-threatening diseases, with drug shortages in the United States nearing record levels.
Hospitals are scouring shelves for supplies of a drug to reverse lead poisoning and a sterile fluid needed to stop the heart for bypass surgery. Some antibiotics are still scarce after the winter flu season, when doctors and patients frantically chased drugs for ailments like strep. Even children’s Tylenol was hard to come by.
Hundreds of drugs are on the list of drugs in short supply in the United States, as officials struggle with an opaque and sometimes broken supply chain, quality and financial issues leading to production shutdowns.
The shortages are so acute that they are attracting 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 support 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 makers, supply chain experts and patient advocates have appeared before lawmakers to discuss the issues.
The lack of generic forms of chemotherapy to treat lung, breast, bladder and ovarian cancer has only added to the concern.
“In my opinion, this is a public health emergency,” said Dr. Amanda Fader, a professor at the Johns Hopkins School of Medicine and president-elect of the Society of Gynecologic Oncology, “because of the breadth of individuals who are affected and the number of chemotherapy agents that are in short supply.”
The American Cancer Society warned last week that delays caused by shortages could result in worse patient outcomes.
“If these drugs are not available, people will receive inferior care,” said Dr. William Dahut, the company’s chief medical officer. “It is the basis of.” These are not third- or fourth-line drugs, where there are many other substances around. These are used beforehand for the people you are trying to heal.”
Ryan Dwars beat pancreatic cancer in 2021, but late last year a scan showed cancerous spots on his liver. Mr Dwars, 39 and a father of two young children, had hoped to receive his last four rounds of chemotherapy in April.
Then his doctor delivered the startling news: He didn’t cut those who were prioritized for treatment.
“The light at the end of the tunnel was in sight,” said Mr. Dwars, a special education teacher in Iowa City. “It was even worse, being so close—and now this.
Laura Bray, who founded the nonprofit Angels for Change, works as an intermediary between patients, health systems and pharmaceutical companies for what she calls “microsources,” hard-to-find drugs.
“Will we have the determination and sense of urgency to fix it?” asked Ms. Bray, an adjunct professor of business who briefs the White House and Congress. “It’s possible. It can be done. It happens in other supply chains. But we have to focus on it and we have to think about how to end it — instead of mitigating it. I think the jury is out on that.”
For Mr Dwarse, Ms Bray contacted the manufacturer of cisplatin, the chemotherapy he needed, and arranged for a supply to be sent within days and for the others to his hospital. Some states across the country weren’t so lucky, facing terrifying 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 long-term drug supply shortages includes national security, economic and health officials. Bloomberg reported earlier about involvement in the White House.
Officials discussed possible measures such as tax incentives for generic drug makers and greater transparency about the quality of generic drugs. Current incentives favor drugmakers with the lowest prices, including those that could lower costs — leading to disruptive plant shutdowns if the FDA demands a fix. (Some shortages, such as a shortage of weight-loss drugs, are the result of skyrocketing demand, while others have been attributed to overprescribing, including antibiotics, or a lack of investment in potential alternatives.)
The FDA, which employs a team of about 10 people who work day-to-day to mitigate and report drug shortages, said it is asking Congress for authority to obtain more information about the drug’s manufacturing and supply chain.
But the agency also raised concerns with the White House about the serious financial strain on the generic drug industry — an economic problem that FDA officials say they are ill-equipped 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 have to fix the underlying economics if we want to fix this situation,” said Dr. Califf May 11 to House panel.
David Gaugh, interim executive director of the Affordable Care Association, which represents generic drug makers, recalled warnings from FDA officials at an April meeting that more would likely follow the recent bankruptcy and shutdown of Akorn Pharmaceuticals.
“The shortage is on the rise. We all saw it,” Mr. Gaugh said in an interview. “And it’s probably going to get worse, not better, very soon.
Mr Gaugh cited figures which underlined the pressure facing the generics industry. Even as the number of generic drug makers has increased, an assessment by IQVIA, a healthcare analytics company, showed that the market has consolidated, with three buyers accounting for about 90 percent of generic drug purchases. The intermediaries are affiliated 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 did not respond to requests for comment.
Competition for contracts with these intermediaries pits American manufacturers against those in India, where labor costs are much lower. When a generic drug company can’t win a contract for a drug, it tends to stop making it and can see already low profits shrink.
“The margin for error is much narrower if you’re a generic manufacturer,” Mr. Gaugh said.
Hospital pharmacists and supply chain experts were stunned in February by the sudden shutdown of Akorn, whose products were then recalled because there were no staff left to deal with potential quality issues.
That added “insult to injury,” said Eric Tichy, chair of the division of supply chain at the Mayo Clinic and chairman of the board of the End Drug Shortages Alliance.
Akorn made roughly 100 medications, including bottles of albuterol, that children’s hospitals relied on to ease their breathing problems. And it was the only company to make an antidote for lead poisoning, said Dr. Silent.
“Health is so fundamental for our country to function well,” said Dr. Silent. “And then we have the domestic producer that’s just declining and there’s not a lot of action.”
Four Senate bills with bipartisan support could help get generic drugs to market faster by addressing tactics or loopholes that cause delays. During the house hearing about the shortfalls on Thursday, Anthony Sardella, a business research consultant at the University of Washington in St. Louis, said generic drug prices have dropped about 50 percent since 2016.
“However, low prices come at a high price,” Mr. Sardella said, noting that they can lead to cost-cutting that can lead to quality problems.
A recent example was Intas Pharmaceuticals, a company in India that makes three key chemotherapy drugs that are hard to find: methotrexate, carboplatin and cisplatin, the drug Mr. Dwars needed. Intas temporarily suspended drug production after FDA found serious quality control violations.
During an unannounced visit to the Intas plant, FDA inspectors discovered a “truck full” of hundreds of plastic bags filled with torn and shredded documents. report issued in December. One quality control worker doused the torn boards with acid and stuffed them into 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 report said. The agency also cited a number of other problems.
To ease the disruption, Intas’ U.S. distributor, Accord Pharmaceuticals, said several batches were third-party tested, certified and released to the U.S. market. Among them were procedures organized by Mrs. Bray that reached patients in Iowa.
The companies were working with the FDA to resume production for U.S. customers, Accord said in a statement, adding that it considered the shredding to be an “isolated incident.”
The Society of Gynecologic Oncology sent out a nationwide survey in recent weeks. In response, doctors in 35 states said they had almost no supplies of key chemotherapy drugs, even at major cancer centers and teaching hospitals.
Dr. Patrick Timmins, a partner at Women’s Cancer Care Associates in Albany, N.Y., said his practice ran out of some chemotherapy drugs on May 9, but still has 25 patients who need them.
“Our patients are at war and we’re taking away their weapons,” said Dr. Timmins. “It’s absolutely ridiculous that we can’t figure out a way, at least in the short term, to get our patients on treatment and in the long term to solve these recurring problems.”
When Ms. Bray met with White House staff in late April, she said she recommended creating an exchange to get drugs where they are needed most and increasing the production of small-batch drugs, often referred to as compounding.
Dr. Kevin Schulman, a professor of medicine at Stanford who has studied the generic drug industry, said he urged the White House team to examine how much power intermediary companies have in contracting with generic drug makers. He said they demand the lowest prices, but unlike a customer-oriented company like Apple, which contracts with suppliers around the world, drug brokers bear no responsibility when shortages occur.
Dr. Schulman said he recommended expanding government contracts with the nonprofit Civica, which sells generic drugs at slightly inflated prices, which can help generic makers run a stable business.
“Intermediaries are pushing people out of the market,” said Dr. Schulman. “I think it’s a market problem and we need a market-level solution.”
He produced the sound Kate Winslett.