FDA Will Allow Import Of Chemo Drug From China Amid Dire Shortage

KFF Health News – The drug, an injectable called cisplatin, is prescribed for up to 20% of all cancer patients, according to the National Cancer Institute. The FDA is also allowing the resumption of cancer drug imports from an Indian manufacturer with a history of inspection problems.

[Cisplatin is a chemotherapy drug used to treat testicular, ovarian, bladder, head and neck, lung and cervical cancer. It may also be used to treat other cancers.]

USA Today: U.S. To Import Chemotherapy Drug Cisplatin From China To Ease Shortage
Citing a shortage of commonly prescribed drugs for U.S. cancer patients, the Food and Drug Administration will temporarily allow overseas drug manufacturers to import some chemotherapy drugs.

The FDA will let Qilu Pharmaceutical, a drug manufacturer in China, import the injectable chemotherapy drug cisplatin in 50-milligram vials. Toronto pharmaceutical company Apotex Corp. will distribute the medication in the United States. (Alltucker, 6/5)

The Washington Post: Record-High Shortage Of Chemo Drugs Puts Patients At Risk
Cancer patients and their doctors are grappling with a record-high shortage of effective chemotherapy, putting their treatment — and lives — at risk. “The majority are cheap, generic drugs that have been utilized in cancer medicine for decades,” says Satyajit Kosuri, clinical director of the stem cell transplant and cellular therapy program at the University of Chicago, who has experienced the consequences firsthand.

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At the end of last year, there were 295 active medication shortages, ranging from antibiotics and anesthetics to cardiac mediations and chemotherapy drugs, according to a Homeland Security and Governmental Affairs report, a 30 percent increase since 2021. (Ebersole, 6/5)

More on cancer treatments and research —

USA Today: DNA Sequencing Improves Cancer Treatment But Remains Underused. Why?
Unlike many oncologists, the tears Dr. Thomas Roberts often saw in his office were those of joy. His patients had been told they had less than six months to live. But Roberts, then a fellow specializing in lung cancer care at the Dana-Farber Cancer Institute, was able to give many an extra lease on life.

Because they had certain genetic mutations in their tumors, he could promise them at least another year and often three, five or more. (Weintraub, 6/6)

Stat: The Woman Behind AstraZeneca’s Cancer Winning Streak
It was the kind of moment scientists who develop new medicines wait their entire careers to experience.

On Sunday, thousands of oncologists applauded after researchers presented data on AstraZeneca’s Tagrisso. When given after surgery to the right lung cancer patients, selected using genetic tests, it cut the death rate in half. (Herper, 6/6)

In related news about the FDA —

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Stat: FDA Cancer Head Wants Advisory Panels To Keep Voting On Drugs
As commissioner of the Food and Drug Administration, Robert Califf has made clear he’d like to do away with the votes that punctuate meetings of expert panels evaluating new drugs for approval.

On Sunday, Richard Pazdur, director of the FDA’s Oncology Center of Excellence, took issue with his boss. (Chen, 6/5)

Stat: More Than 200 FDA Staffers Have Retired In Less Than A Year
More than 230 people have retired from the Food and Drug Administration since Oct. 1, Chief of Staff Julie Tierney said Monday.

It’s part of a bigger wave of exits: In total, 634 employees have left the agency, which has a staff of about 18,000 people. There are about 2,000 vacancies at the FDA, which is a normal level at an agency that has for a long time struggled to hire and keep employees who can make bigger salaries in the private sector. (Wilkerson, 6/6)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

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