Drug Shortages Near an All-Time High, Leading to Rationing

Thousands of patients are facing delays in getting treatments for cancer and other life-threatening diseases, with drug shortages in the United States approaching record levels.

Hospitals are scouring shelves for supplies of a drug that reverses lead poisoning and for a sterile fluid needed to stop the heart for bypass surgery. Some antibiotics are still scarce following the winter flu season when doctors and patients frantically chased medicines for ailments like strep throat. Even children’s Tylenol was hard to find.

Hundreds of drugs are on the list of medications in short supply in the United States, as officials grapple with an opaque and sometimes interrupted supply chain, quality and financial issues that are leading to manufacturing shutdowns.

The shortages are so acute that they are commanding the attention of the White House and Congress, which are examining the underlying 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 for shoring up the pharmaceutical supply chain, at a time when the United States remains heavily reliant on medicines 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 to treat lung, breast, bladder and ovarian cancers has only heightened concerns.

“This is, in my opinion, a public health emergency,” said Dr. Amanda Fader, a professor at the Johns Hopkins School of Medicine and a president-elect of the Society of Gynecologic Oncology, “because of the breadth of the individuals it affects and the number of chemotherapy agents that are in shortage right now.”

The American Cancer Society last week warned that delays caused by the shortages could result in worse outcomes for patients.

“If these drugs are not available, people are going to get inferior care,” Dr. William Dahut, the society’s chief medical officer, said. “That’s the bottom line. These aren’t third- or fourth-line drugs where there are multiple other agents around. These are used up front for people you are trying to cure.”

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 girls, had hoped to receive his final four doses of chemotherapy in April.

Then his doctor delivered stunning news: He didn’t make the cut of those given priority for the treatment.

“The light at the end of the tunnel was within sight,” Mr. Dwars, a special education teacher in Iowa City, said. “It made it even worse to be so close — and now this.”

Laura Bray, who founded a nonprofit called Angels for Change, works as a liaison among patients, health systems and drug companies to “micro-source,” as she calls it, hard-to-find medications.

“Will we have the resolve and sense of urgency to fix this?’’ asked Ms. Bray, an adjunct business professor who has been providing information to 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 ending it — instead of mitigating it. I think the jury’s out on that.”

For Mr. Dwars, Ms. Bray contacted a maker 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 around the country have not been as fortunate, encountering frightening gaps between treatments.

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

Officials have been debating possible measures like tax incentives for generic drugmakers and greater transparency around generic drug quality. The current incentives favor drugmakers with the lowest prices, which includes those that might cut corners — leading to disruptive plant shutdowns if the F.D.A. demands a fix. (Some shortages, like those of weight-loss drugs, are the result of sky-high demand, while others have been attributed to overprescribing, including for antibiotics, or a lack of investment in potential alternatives.)

The F.D.A., which employs a team of about 10 people who do the day-to-day work of mitigating and reporting drug shortages, has said it is seeking authority from Congress to get additional information about the drug manufacturing and supply chain.

But the agency has also expressed its concerns to the White House about severe financial strain in the generic drug industry — an economic problem that F.D.A. officials say they are not suited to address.

Dr. Robert Califf, the F.D.A. commissioner, highlighted the agency’s views during recent appearances before Congress, saying officials can only plug so many holes.

“We have got to fix the core economics if we’re going to get this situation fixed,” Dr. Califf told a House panel on May 11.

David Gaugh, the interim chief executive of the Association for Accessible Medicines, which represents generic drugmakers, recalled warning F.D.A. officials in an April meeting that the recent bankruptcy and shutdown of Akorn Pharmaceuticals would likely be followed by others.

“Shortages are on the rise. We’ve all seen that,” Mr. Gaugh said in an interview. “And it is likely going to get worse, not better, very soon.”

Mr. Gaugh cited data underscoring pressure facing the generic industry. Although the number of generic drugmakers has increased, a review by IQVIA, a health care analytics company, showed that the market has consolidated such that three buyers account for about 90 percent of generic drug purchases. The intermediaries are combined major drug distributors and retail chains, like 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 reply to requests for comment.

The competition for the contracts with those intermediaries pits U.S. manufacturers against those in India, where labor costs are far lower. When a generic drug company can’t get a contract for a medication, it tends to stop making it and might see already-slim profits shrink.

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