SAN ANTONIO – A serious shortage of chemotherapy drugs has forced the U.S. Food and Drug Administration to get help from other countries.
This weekend, the FDA confirmed it is working with China and Canada to help relieve the shortage of the specific medication cisplatin, which is used to treat over 10 types of cancer.
“We use it in gynecological malignancies. We use it in thoracic malignancies and urinary malignancies. It’s very common,” said oncologist Dr. Mark Bonnen, physician in chief for the Mays Cancer Center at UT Health San Antonio.
The drug is one of 11 chemotherapies that are experiencing shortages, including:
- Fludarabine Phosphate
- Leucovorin Calcium
- Lutetium Lu 177 Vipivotide Tetraxetan (Pluvicto)
- Streptozocin (Zanosar) Sterile Powder
Those shortages are said to be caused by labor shortages, supply chain issues, and mainly the low-profit margins for drug companies to make generic chemotherapy drugs.
“Cisplatin is the drug that we’ve been most worried about in the recent month or so,” Bonnen said.
That’s because in March, the plant in India, which makes 50% of the U.S. supply, was shut down for “quality assurance failures.”
“We’ve been pretty lucky. Our supplier had continued to supply us pretty regularly until last week. And last week, they initiated a new way of ordering the drug, which actually required us to order for a specific patient with a specific diagnosis,” Bonnen said.
Right now, the Mays Cancer Center cannot order the drug in bulk as it did before.
However, unlike many other centers nationwide, patients have not been affected yet.
The first short-term fix other doctors are taking is finding alternative medicines.
That is a possibility for some cancers, but not all patients take cisplatin.
“The two areas where there really is no alternative right now is in bladder and testicular cancer,” Bonnen said.
For those patients, other centers nationwide have already resorted to lowering doses.
“There’s rounding down, so they round the dose down to preserve the supply, not having to open another vial,” Bonnen said.
Some doctors are also extending the time between doses.
“Hopefully, in the next few days, we won’t have to resort to that,” Bonnen said.
The FDA has cleared the way for the Chinese company Qilu Pharmaceutical to send its version of cisplatin to the U.S., and Canadian pharmaceutical company Apotex will distribute it.
Doctors should be able to start ordering it Tuesday. This is, however, just a temporary solution, though.
Bonnen agrees with doctors across the country that the long-term solution is creating legislation that incentivizes or pushes more drug companies to produce and supply these generic cancer drugs so there is no global reliance on just one or two suppliers.
“It’s not uncommon for the FDA to do an inspection and find some concerns and clear those up. You have to shut down while that’s done. That’s OK if you have four or five manufacturers, but if you have one manufacturer creating 50% of the drugs, it’s so impactful,” Bonnen explained.
He said 90% of the drugs we use in the U.S. are generic brands, and hundreds of drugs are at risk of having a shortage at any given time.
“There’s sort of this race to the bottom on price with these generic producers. So how do we incentivize manufacturers to produce these drugs? I think this is a policy question that the FDA is going to have to look at,” Bonnen said.
He said patients are starting to fight for those controls.
“They’re not happy, and I don’t blame them. To be deep in the throws of a battle with cancer and on top of it have a question as to whether you can get the life-saving medication you need,” Bonnen said.
He hopes his patients will not have to feel that stress as the foreign supply begins to trickle into the U.S.