Thousands of patients are facing delays in receiving treatment for cancer and other life-threatening diseases, and drug shortages in the United States are nearing record levels.

Hospitals are scouring shelves for a drug that cures lead poisoning and a sterile fluid needed to stop the heart before bypass surgery. Some antibiotics are still in short supply after the winter flu season, when doctors and patients raced for cures for illnesses like strep throat. It was hard to find even children’s Tylenol.

Hundreds of drugs are on the United States drug shortage list as officials grapple with opaque and sometimes intermittent supply chains, quality and financial issues that are causing production to halt.

The shortage is so severe that it is drawing the attention of the White House and Congress, which are studying the root causes of the instability of the generic drug market, which accounts for about 90 percent of prescriptions in the domestic market.

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 makers, supply chain experts and patient advocates have come before lawmakers to debate the issues.

The lack of generic forms of chemotherapy to treat lung, breast, bladder and ovarian cancers has only heightened concerns.

“In my opinion, this is a public health emergency,” the doctor said. Amanda Fader, professor at Johns Hopkins School of Medicine and president-elect of the Society for Gynecological Oncology, “because of the wide range of people it affects and the number of chemotherapeutic agents that are now in short supply.”

The American Cancer Society warned last week that delays caused by drug shortages could lead to a worsening of patients’ condition.

“If these medicines are not available, people will receive poor quality care,” says the doctor. This was stated by the chief physician of the society, William Daut. “That’s the point. These are not third or fourth line drugs where there are many other agents. They are used in advance for the people you are trying to cure.”

Ryan Dwars beat pancreatic cancer in 2021, but a scan late last year showed cancerous patches on his liver. Mr. Dwars, 39, a father of two little girls, was hoping to get his last four doses of chemotherapy in April.

Then his doctor delivered the startling news: he was not among those given priority treatment.

“There was already a light at the end of the tunnel,” said Mr. Dwars, a special education teacher in Iowa City. “It was even worse being this close – and now it is.”

Laura Bray, who founded the nonprofit organization Angels of Change, works as a bridge between patients, healthcare systems and pharmaceutical companies to “microsource,” as she calls it, hard-to-find drugs.

“Do we have the determination and sense of urgency to fix this?” asked Ms. Bray, an associate business professor who 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 that and think about ending it, not softening it. I think the jury is on that.”

For Mr. Dwars, Ms. Bray contacted the manufacturer of cisplatin, the chemotherapy drug he needed, and arranged for delivery within a few days, and for others to his hospital. Some in states across the country have been less fortunate, facing frightening gaps between treatments.

The White House team working on the broader problem of longstanding drug supply disruptions includes national security, economic and health officials, according to James McKinney, a spokesman for the Food and Drug Administration. Bloomberg previously reported about the involvement of the White House.

Officials are discussing possible measures, such as tax breaks for generic drug makers and greater transparency about the quality of generic drugs. Current incentives favor drug makers with the lowest prices, including those that can cut corners, resulting in devastating plant shutdowns if the FDA calls for a fix. (Some shortages, such as those for weight loss drugs, are the result of incredibly high demand, while others are due to overprescribing, including antibiotics, or a lack of investment in potential alternatives.)

The Food and Drug Administration (FDA), which has a team of about 10 people working to address and report drug shortages on a daily basis, said it is seeking permission from Congress to obtain more information about the drug production and supply chain. supplies.

But the agency has also expressed its concern to the White House about serious financial difficulties in the generics industry, an economic problem that FDA officials say they are not up to the task of solving.

Dr. Robert Califf, FDA commissioner, in recent speeches before Congress, emphasized the agency’s point of view, saying that officials cannot plug too many holes.

“We have to fix the underlying economy if we are going to fix this situation,” the doctor said. Kaliff announced this to the panel of the House of Representatives on May 11.

David Guo, acting CEO of the Affordable Medicines Association, which represents generic drug makers, recalled that at an April meeting, FDA officials warned that Akorn Pharmaceuticals’ recent bankruptcy and closure would likely be followed by others.

“The deficit is growing. We’ve all seen it,” Mr Guo said in an interview. “And it will probably only get worse, not better, very soon.”

Mr Guo cited data highlighting the pressure the generics industry is facing. Although the number of generic drug makers has increased, a survey by IQVIA, a health analytics company, found that the market has consolidated to the point where three buyers account for about 90 percent of generic drug purchases. Intermediaries include 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 Amerisource Bergen. The companies did not respond to requests for comment.

Competition for contracts with these intermediaries pits US manufacturers against those in India, where labor costs are much lower. When a generic drug company fails to secure a contract for a drug, it typically stops producing it and may face a reduction in its already modest profits.

“There is much less room for error if you are a generic manufacturer,” said Mr Guo.

Hospital pharmacists and supply chain experts were stunned in February by the sudden closure of Akorn, whose products were recalled because there were no staff left to deal with potential quality issues.

It added “an insult to the injury,” said Eric Tichey, chairman of the supply chain at Mayo Clinic and chairman of the board of the Medicines Shortage Alliance.

Acorn produced about 100 drugs, including albuterol bottles that children’s hospitals relied on to relieve breathing problems. And it was the only company that made the antidote for lead poisoning, Dr. Tichi said.

“Health is so important to the smooth functioning of our country,” says the doctor. Tichi said. “And then we have a domestic manufacturer that just goes bust and no action happens.”

Four bipartisan Senate bills could help bring generic drugs to market faster by eliminating tactics or loopholes that cause delays. While at home hearing Thursday, Anthony Sardella, a business research advisor at Washington University in St. Louis, said generic drug prices have fallen by about 50 percent since 2016.

“But low prices come at a cost,” Mr Sardella said, noting that they can lead to cost reductions that could lead to quality issues.

A recent example is Intas Pharmaceuticals, an Indian company that makes three key chemotherapy drugs that are hard to come by: methotrexate, carboplatin and cisplatin, the drug Mr. Dwars needed. Intas temporarily suspended drug production after the FDA found serious quality control violations.

During an unannounced visit to the Intas plant, FDA inspectors found a “truck full” of hundreds of plastic bags filled with torn and shredded documents. report released in December. The report states that one of the QC staff poured acid on the torn records and stuffed them into a trash bag.

The report says FDA inspectors collected documents and found quality control records for products destined for the US. The agency also mentioned a variety of other issues.

To ease supply disruptions, Intas’ US distributor, Accord Pharmaceuticals, said several batches have been third-party tested, certified and released to the US market. Among them were treatments organized by Ms. Bray that reached patients in Iowa.

The companies have been working with the FDA to restart production for U.S. customers, Accord said in a statement, saying the shredding was an “isolated incident.”

In recent weeks, the Society for Gynecological Oncology sent out a nationwide survey. In response, doctors in 35 states said they had almost no stocks of essential chemotherapy drugs, even at major cancer centers and teaching hospitals.

Dr. Patrick Timmins, partner at Women’s Cancer Care Associates in Albany, New York, said his clinic ran out of some chemotherapy drugs on May 9 but still has 25 patients who need them.

“Our patients are at war, and we are busy taking their weapons,” the doctor said. Timmins said. “It’s absolutely ridiculous that we can’t come up with a way, at least in the short term, to cure our patients, and in the long term, solve these recurring problems.”

When Ms. Bray met with White House staffers in late April, she said she recommended creating an exchange to get drugs where they are needed most and increasing the production of drugs in small batches, often called compounding.

Dr. Kevin Shulman, a Stanford professor of medicine who has studied the generic drug industry, said he urged the White House team to look into the power of intermediary companies in awarding generic drug contracts. He said they demand minimum prices, but unlike a customer-focused company like Apple, which contracts with suppliers around the world, middlemen don’t take any responsibility when there is a shortage.

Dr. Shulman said he recommended expanding government contracts with the nonprofit Civica, which sells generic drugs at slightly inflated prices, which could help generic drug makers run sustainable businesses.

“Intermediaries are pushing people out of the market,” the doctor says. Shulman said. “I think this is a market problem and we need solutions at the market level.”