Dan Zuckerman, MD
The door isn’t fully closed on the acute oncology drug shortages of 4 years ago, observers say, though the FDA has established rules for greater disclosure by manufacturers and continues to tweak guidelines that would require far more information about manufacturing processes and production issues.
The FDA sought feedback on its draft quality metrics guidance through an open comment period that continued through the end of September. The changes would require manufacturers to provide more information about drug quality and aid the FDA in heading off potential drug shortages.1
Details such as the success and failure of attempts to produce quantities of particular drugs would be required information as well as details on product quality complaints. Also, the FDA has suggested in the draft guidance that it be notified of corrective actions taken and be informed about any involvement by senior management in product reviews. In response, members of the International Society for Pharmaceutical Engineering (ISPE) have advocated for a phased introduction, with just a few of the requirements applying to higher-risk facilities, and with voluntary reporting, initially, to limit the administrative burden on manufacturing companies.
The director of the Drug Information Service at University of Utah Health Care, Erin Fox, says a lack of transparency in manufacturing and product supply has been a key issue in drug shortages of recent years, and in efforts to understand the quality and origin of drugs on the United States market. For this reason, she says the FDA’s quality metrics effort is “a really good step,” though its value to the physician community is limited in that the data provided by manufacturers will not be made publicly available.
“You can go to the store and buy a pack of raspberries and see if they’re from California or from Mexico, but you can’t know that about the medicine, and that’s what’s really frustrating,” she says.
Fox praises a requirement that drug companies notify the FDA of pending shortages, a rule enacted through the FDA Safety and Innovation Act of 2012. “Overall, we have a picture of improvement—significant improvement—especially if you think back to where we were in 2010 and 2011, when patients were being turned away from chemotherapy,” she says.
Figure 1. New National Drug Shortagesa
aShortages for 2015 reflect first 6 months of year only.
Source: University of Utah Drug Information Service
Even so, now is not the time to ease the pressure on the FDA, says Dan Zuckerman, MD, executive medical director of St. Luke’s Mountain States Tumor Institute in Idaho, a group of 5 treatment centers grappling with ongoing shortages of key drugs.
“What I wouldn’t want to see is a sense that the issue is solved, that we can forget about it for now,” says Zuckerman. “I think that for the foreseeable future it may need to stay on both our radar and the FDA’s radar.”
Zuckerman participated in an ASCO lobbying effort in the early part of this decade to raise the profile of the drug shortage problem so that the FDA would take ownership and spearhead a meaningful reform effort. “We’re pleased to see that steps have been taken to address this through the FDA, through the lobbying efforts by ASCO, and by having more visibility on the congressional side.”
Although the drug shortages were acute, a key culprit was Teva’s Irvine, California, manufacturing plant, which was the source of up to 55 products and came to a lengthy standstill after it failed an FDA inspection.
Zuckerman recalls the crisis too vividly to believe that it couldn’t happen again without ongoing vigilance.
“We were really becoming concerned, on too routine a basis, that patients weren’t getting the care they needed, particularly for pediatric drugs,” he says. Obtaining supplies of needed drugs was not always possible, and the pharmacy at St. Luke’s often had to juggle priorities and call around to outside facilities in search of fresh supplies, finding in many cases that those facilities were going through exactly the same difficulty.