Cancer drugs rank among top 5 hardest hit by shortages in US – WSVN 7News | Miami News, Weather, Sports

(CNN) – As the United States faces near-record drug shortages, cancer treatments have been hit hardest.

According to data from the University of Utah Drug Information Service in late March, there are active shortages of about two dozen chemotherapy drugs, the fifth most of any drug category.

“The fact that so many chemo drugs are in short supply is really concerning,” said Michael Ganio, senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists.

Unlike some other drugs that are also among the top five bottleneck categories, such as antimicrobials, chemotherapy drugs often have no alternatives, he said. And the shortages are affecting the treatment of a variety of cancers.

“One of the most important predictors of how well a patient will respond to treatment is taking the full dose on the right schedule,” Ganio said. “So when we can’t administer the drug because we just can’t get it, that’s heartbreaking.”

Overall, University of Utah data shows there were more than 300 active shortage drugs in the US at the end of March, including nearly 50 new shortages that piled up in the first three months of the year.

The last time active medicine shortages — both newly reported and ongoing — were this high was in 2014, the data show.

“Bottlenecks are still emerging, and they’re not being fixed, or they’re not resolving as quickly as new bottlenecks are emerging,” Ganio said.

On Thursday, the US House of Representatives’ Energy and Trade Subcommittee on Oversight and Investigations held a hearing examining the causes of these shortages.

This also includes the increased demand. But experts say some notable shortages — like amoxicillin during the last respiratory virus season and Adderall for ADHD — are the exception.

“They don’t really tell the story of the drug shortages,” Ganio said.

Instead, the hearing focused more on manufacturing issues and the broader structure of the US drug market.

The US Food and Drug Administration, in particular, has been criticized for delaying inspections, particularly at international bodies, which account for more than half of the manufacturers supplying the US.

A January 2022 report by the Government Accountability Office, a federal regulatory agency, identified “long-standing challenges” for FDA’s Foreign Inspection Program and called for more formal steps to improve it.

Effective inspections of both domestic and foreign manufacturing facilities are “absolutely critical to ensuring the quality and safety of the drugs that US citizens consume,” said Anthony Sardella, chair of the API Innovation Center, a nonprofit organization focused on expanding the drug industry US drug supply concentrated. pharmaceuticals manufactured.

“They are also extremely important to ensure the stability of the market,” said Sardella, who was present as a witness at the hearing.

But in a hearing Thursday before the Energy and Trade Subcommittee on Health, FDA Commissioner Dr. Robert Califf that the economic problems underlying the drug shortages are “outside the FDA’s purview.”

The FDA is “filling gaps in the levee,” he said, but it’s difficult to enact change if it’s not profitable for drug companies.

“These drug shortages are growing because of a distorted market,” said Rep. Kathy Castor, D-Florida, senior member of the subcommittee.

“The current haphazard approach of tackling the crisis episode by episode does nothing to provide American families with the safety and quality of care they need and deserve.”

Hundreds of impending shortages are looming, and Califf has urged pharmaceutical companies to bring it to the FDA’s attention.

“Each company doesn’t know what the other company is doing because it’s in competition,” he said. “If there is a shortage in a company, we need to be able to coordinate between those people.”

Outside of the FDA, there is a small team of officials in the White House focused on strengthening supply chains and drug quality, a senior administration official confirmed to CNN. The team was first reported by Bloomberg News.

The team, the senior official said, has been meeting “for a while” and is made up of “several” White House offices, including the Domestic Policy Council and the National Economic Council.

“The Biden-Harris administration remains focused on strengthening the resilience of critical supply chains, including for medical products such as pharmaceuticals,” the official said, citing five executive orders issued by President Joe Biden since taking office aimed at “[catalyzing] State-level action to achieve these goals.”

Blame aside, patients remain at the center of the problem.

“Every day there is a serious impact on patients,” said Laura Bray, founder of Angels for Change, an advocacy group working to end drug shortages. “We must also not forget the emotional trauma you inflict on a family going through a medical crisis.”

She experienced it firsthand in 2019 when her 9-year-old daughter Abby couldn’t get the drug to treat her leukemia due to a shortage.

Abby is fine now, but 9 out of 10 oncologists say drug shortages have resulted in patient harm, including death, said Bray, who testified at Thursday’s oversight hearing.

“Patients deserve access to these medicines. The doctors, nurses and care team trying to solve and save these crises deserve easy and equitable access to these medicines.”

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