FDA official gives an unusually clear explanation of cancer drug shortages

There's apparently a cisplatin and carboplatin shortage, and The Cancer Letter has a great interview with Dr. Richard Pazdur, who is the head of their oncology center of excellence: 

“The current cisplatin shortage followed an inspection and subsequent identification of quality issues at a single company’s manufacturing facility,” Pazdur said. “The company shut down the production line, leading to the current shortage. As a result of the cisplatin shortage, a ripple effect was observed leading to an increased demand for carboplatin and the manufacturing challenges in meeting an increased carboplatin demand. 

“To restore supply of cisplatin, FDA has continued to offer assistance to all five manufacturers on anything they can do to increase supply. In addition, we are exploring temporary importation to help meet patients’ needs during the shortage. FDA has also requested that manufacturers submit data to support additional expiration dating for lots already in distribution that are approaching their labeled expiration.”

Pazdur said FDA’s ability to manage shortages is limited.

“Based on current laws, FDA cannot require a manufacturer to report an increase in demand that may lead to a drug shortage,” Pazdur said. “Appropriately, we cannot require a company to manufacture a drug.

“We cannot require a company to make greater quantities of the drug—specifically, to step-up production. We cannot require a distributor to report on the quantities that are distributed and specific purchasers who may be given priority.

“In addition, FDA cannot require that essential drugs, such as cancer therapeutics, have diversified supply chains such that there is not overreliance on a single facility or country for an active pharmaceutical ingredient (API) or key starting materials. However, even when there is more than one manufacturer for a drug, most facilities are operating near capacity and are unable to rapidly fill the void if a manufacturer ceases production due to a manufacturing quality issue,” Pazdur said.

It really feels like there is a problem with generic drugs, the needed volume and their difficulties with manufacturing quality. Clearly, there's not much that the FDA can currently do, but I wonder if there is a place for Congress to provide some kind of incentive to generics manufacturers to keep their quality high for these essential high-volume drugs...