The recent national shortage in chemotherapy drugs points to a need to overhaul the generics market
A cancer diagnosis is already devastating. It’s even more gut-wrenching when your doctor tells you that a drug shortage has disrupted your treatment regimen—that your hospital can’t get its hands on the very drugs that can save your life. Many cancer patients are now facing this grim reality as hospitals nationwide weather what is “likely the worst chemotherapy drug shortage crisis that the U.S. has ever seen,” says Amanda Nickles Fader, a gynecologic oncologist at Johns Hopkins Medicine.
The scarcity of oncology drugs is particularly dire because these medications can so directly mean the difference between life and death. The most affected treatments include the platinum-based injectable drugs carboplatin and cisplatin, which are used to treat breast cancer, gynecologic cancers, testicular cancer, head and neck cancers and bladder cancer.
Generic drugs are often priced so low that manufacturers have to operate on slim profit margins. To break even, these companies run at near-maximum output levels. On top of that, they may be tempted to cut corners and roll back quality control just to reduce costs. There are often only a few or even a single manufacturer of a given generic drug, so when one of them shutters, that is enough to throw off the entire supply chain.
To mitigate the generics shortage, the FDA temporarily authorized Chinese company Qilu Pharmaceutical to import nonapproved cisplatin from China into the U.S. and Canadian company Apotex to act as the drug’s U.S. distributor. The agency also relaxed part of its import alert to Intas to allow some of the manufacturer’s products that are in shortage, including platinum chemotherapy injectables, to enter the U.S.
Solving the Shortages One obvious solution is to boost manufacturing. This could take the form of artificially jacking up demand for generics—enough to sustain multiple manufacturers in the industry. For instance, the government could purchase excess capacity by paying for more drugs than the market needs.
After all, race-to-the-bottom pricing for generics is the root cause of their throttled supply chain, experts say. While low prices may seem like a good thing for patients, they can’t be so low that manufacturers have no incentive to stick around. “There’s going to be a delicate balance,” says Brooke Bernhardt, chief pharmaceutical officer at St. Jude Children’s Research Hospital.
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