FDA Limited in Managing Drug Shortages: Pazdur
FDA Oncology Center of Excellence director Richard Pazdur says the current shortage of most cancer drugs represents a market failure and FDA is limited in what it can do to manage shortages. Pazdur addressed the shortages in an extensive interview with The Cancer Letter.
He says the shortages of cisplatin and carboplatin are due to manufacturers failing to invest in enhancing production capacity.
“The current cisplatin shortage followed an inspection and subsequent identification of quality issues at a single company’s manufacturing facility,” Pazdur explained. “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.”
He says FDA has offered assistance to all five cisplatin manufacturers on anything they can do to increase supply. It also is exploring temporary importation to help meet patient needs during the shortage. And FDA has requested that manufacturers submit data to support additional expiration dating for lots already in distribution that are approaching their labeled expiration.
Pazdur emphasized that the agency’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. 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 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 says early notification is the key to prevention, and said FDA’s approaches to the prevention and mitigation of drug shortages include prioritization of medically necessary products; ensuring the availability of drugs while maintaining quality by communicating across the ecosystem to help find new sources; and working with companies to address problems by expediting submissions that can increase supply.