August 20, 2013 — Cancer drug shortages continue to confound the best efforts of the Food & Drug Administration to head them off, in part because the agency has little authority to address what causes them to occur, according to a co-author of an attention-getting study about shortages.
Dr. Keerthi Gogenini, a medical oncologist with the Abramson Cancer Center at the University of Pennsylvania, helped present one of several studies that grabbed headlines at the June meeting of the American Society of Clinical Oncology. Evidence-Based Oncology, checked back with Gogenini and with the FDA on the current state of shortages for its August issue. EBO is an indexed news publication that is a supplement to The American Journal of Managed Care.
An FDA spokeswoman, Lisa Kubaska, PharmD, credited the 2012 Food and Drug Safety Innovation Act with allowing the agency to identify shortages and find temporary solutions, such as importations of drugs. But Gogenini said on the front lines, the picture is not that rosy, although she believes the FDA is doing what it can.
“There are factors that contribute to drug shortages that the agency has limited control over,” Gogenini said.
The FDA, Gogenini and multiple other experts attribute cancer drug shortages to quality control problems at large manufacturers. The trouble is, the FDA cannot force drug manufacturers to direct manufacturing resources to generics instead of branded drugs, which cost more. The 2012 legislation basically serves as an early warning system that gives the FDA time to come up with alternatives when a shortage looms.
The June surveys presented at ASCO, including the study conducted at the University of Pennsylvania, showed widespread effects of shortages. In the Penn study, 94 percent of oncologist and hematologists said patients’ treatment had been affected by shortages, and 13 percent reported that patient participation in clinical trials had been compromised.
Gogenini attributes shortages to the lack of redundancy across the manufacturing system, while others have blamed the low cost of generics, which give companies little incentive to invest in capacity for these drugs.
“There are few penalties for failing to supply critical drugs, and no incentive for companies to invest in ‘excess’ capacity,” Gogeini told EBO. “This is not something the FDA would have control over.”