GAO Criticizes FDA Foreign Office Staffing, Drug Shortages

The Government Accountability Office (GAO) continues to monitor FDA staff vacancies at foreign agency posts as part of its identification of high-risk areas needing improvement. A new GAO report notes that as of 7/2016, 46% of FDA foreign offices’ authorized positions, including those conducting medical product investigations, were vacant, and “FDA still faces challenges in recruiting staff to these positions... The Department of Health and Human Services (HHS) agreed with our December 2016 recommendation to establish staffing goals by position type at foreign offices, and FDA indicated that recruiting and hiring have long been challenges at these offices. We will monitor future developments in FDA’s foreign inspection staffing.”

Another area catching GAO’s eye is strengthening FDA’s security over industry and public health data. “In 8/2016, we reported that … [FDA] had a significant number of security control weaknesses jeopardizing the confidentiality, integrity, and availability of its information and systems.” the report says. “The agency did not fully or consistently implement access controls, which are intended to prevent, limit, and detect unauthorized access to computing resources. Specifically, FDA did not always (1) adequately protect the boundaries of its network, (2) consistently identify and authenticate system users, (3) limit users’ access to only what was required to perform their duties, (4) encrypt sensitive data, (5) consistently audit and monitor system activity, and (6) review the physical security of its facilities.” The 2016 report offered recommendations and GAO notes now that the agency has begun implementing many of them.

Additionally, drug shortages continue to be a GAO concern, according to the report. Specifically, it identifies the effect of globalization on FDA’s ability to monitor medical product manufacturing, and the availability of medically necessary drugs as continuing to be top concerns. “The effectiveness of FDA’s foreign offices, which began opening in 2008, has not yet been meaningfully assessed,” the report says. “With regard to ensuring drug availability, the way FDA monitors its drug shortage information remains a concern. Although it implemented a new tracking system — the Shortage Tracker — in March 2016, this is the fourth approach to monitoring shortages that the agency has taken in five years. According to FDA, it routinely enters data into the system, but the agency has not yet developed standard reports to help it manage its efforts, nor has it made plans to use these data to analyze trends or identify patterns to help it predict future shortages.”

GAO also says it remains concerned about the reliability and availability of information that is necessary to monitor postmarket drug safety. “For example,” it says, “FDA has not yet fully implemented a recommendation we made in 2013 to ensure its databases collect reliable and timely data on inspections of certain establishments that compound drugs. In our 2015 high-risk report, we acknowledged the agency’s development of an action plan to respond to drug shortages. However, the agency did not follow through on its agreement to implement a recommendation we made in 2014 to periodically analyze its drug shortage data, and its implementation of an earlier recommendation to develop an information system to systematically track data about drug shortages, including their causes, has been inconsistent. These inconsistencies may undermine FDA’s action plan and its effectiveness. In addition, in December 2015 and May 2016, we identified new concerns regarding the agency’s collection of reliable data regarding postmarket drug safety and shortcomings in its broader strategic planning efforts for drugs and other medical products. As a result, we no longer consider that FDA has met the criteria associated with having an effective action plan, and are therefore changing its rating in this area from met to partially met.”