US FDA's Drug Shortage Effort Questioned By GAO

GAO's 'high risk' report lowers FDA grade for its drug shortage action plans, saying efforts have not been sustained.

The US FDA's effort to deal with the drug shortage problem may be waning, which has led the Government Accountability Office to downgrade the program’s action plans.

The agency had developed "meaningful action plans" to deal with and improve its monitoring of shortages in time for a 2015 assessment, but it has not retained the priority level that had been demonstrated in previous years, GAO said in a Feb. 15 report that urged a redoubling of FDA's efforts.

"FDA has not sustained this level of effort for drug availability activities in the intervening years, and we no longer consider the agency to meet the criteria for having an effective action plan," GAO said in the report updating various government agencies' progress dealing with 'high-risk' areas.

GAO also said FDA needs to "demonstrate that it has the capacity to address multiple challenges we have identified, along with effective monitoring strategies," related to shortages as well as industry globalization.

FDA saw its grade on its action plans for handling shortage problems lowered from meeting the criteria to partially meeting criteria in the report. The move stemmed from problems discovered with the agency's "readiness and plans to collect, track and analyze data related to drug shortages," as well as problems with post-market drug safety monitoring and broader strategic planning, according to the report.

FDA said it agrees with GAO's assertion that agency leadership was committed to and supportive of initiatives related to drug shortages and its ability to monitor product manufacturing. The agency said in a statement to the Pink Sheet that it "continues to implement new processes and procedures to correct data and address gaps in information."

"We agree that ongoing work is needed to meet our public health goals and the FDA is committed to continued work in these important areas," the agency added.

FDA has disagreed with GAO over shortage issues previously, including how shortages are defined. In 2014, GAO told a House committee that shortages were increasing, but FDA disputed the finding, saying that GAO was using a different definition of a shortage, and the agency's figures indicated shortages were flattening. (Also see "Drug Shortage Analysis Puts FDA At Loggerheads With GAO" - Pink Sheet, 10 Feb, 2014.)

Shortage Plans Need Development

GAO recommended in 2011 that FDA track shortage data and then in 2014 said it should routinely analyze its shortage data, but found that FDA's response has been "mixed" and that an action plan to implement the recommendations has not been fully developed.

Shortage data systems in particular have been difficult for FDA to develop and enhance. GAO said FDA launched a new system in 2016, called the Shortage Tracker, which was its fourth approach to shortage management in five years. While promising, it only had information dating back to January 2015, "precluding the agency from easily conducting extensive analyses of trends prior to that date," according to the report (see table).

FDA Drug Shortage Database Timeline
Year	Tracking Method
2011	Email status reports and electronic spreadsheet
2012	Drug shortage database launched
2013	Database use suspended for development of new "more robust" shortage system
2014	Shortages documented using manual logs during transition; Drug shortage data system launched late in the year
2016	Shortage Tracker launched
Source: GAO high risks report

"Moreover, the agency has not yet made plans to use these data to analyze trends or identify patterns to help it predict future shortages, nor has it developed standard reports to assist with managing its efforts," GAO said in the report.

GAO's tone was somewhat different in a July 2016 report that said new shortages generally have decreased between 2011 and 2015. It said FDA's median review time for applications related to shortages may have helped address some of them.

FDA said in its fiscal year 2017 budget request that the median approval time for abbreviated new drug applications was expected to be 36 months in FY 2016 and FY 2017, a six-month improvement from the median at the end of FY 2015. (Also see "FDA's Generic Drug Workload, Productivity Beating Budget Estimates" - Pink Sheet, 22 Feb, 2016.)

GAO also said in the 2016 report that ongoing shortages remained high, totaling more than 250 each year since 2012. (Also see "FDA’s Priority Reviews May Have Helped Reduce New Drug Shortages" - Pink Sheet, 8 Aug, 2016.)

Shortage Reports Need Improvement

Shortage monitoring at FDA also remains problematic with limited information in the available reports, GAO said.

And even though FDA's Office of Pharmaceutical Quality would like to use shortage data "to conduct rigorous analyses for predicting shortages and risk factors," reports from the drug shortage staff also are not distributed to "any FDA components, raising questions about the agency's commitment to conducting such analyses," GAO wrote.

FDA said it is "engaged in activities to increase and streamline the capture of specific information into its database and is facilitating additional analyses for oversight of post-market drug studies and safety issues."

Annual reports to Congress on drug shortages also contain no more than nine months' worth of data instead of a full year. FDA told GAO that because the report is due by the end of each calendar year, it is impossible to give an entire year's worth of data. But GAO also indicated that FDA has never met the Dec. 31 deadline to issue the report and has published the shortage report as late as April the following year.

"Given that the agency has never met the publication deadline, we believe it would be more helpful that policymakers receive a full year's worth of data, such as data covering the federal fiscal year … so they could more closely monitor shortage information themselves and obtain a more realistic view of this serious public health problem," GAO said in the report.

GAO also mentioned two other issues related to agency operations in the "high risk" report:

• FDA's information security, which could put health data at risk (Also see "FDA's Information Security Fixes Expected To Be Completed Within A Year" - Pink Sheet, 29 Sep, 2016.), and
• Vacancies at FDA's foreign posts, which could delay inspections. (Also see "US FDA’s Foreign Inspection Agenda: Visit The 1,000 Facilities It’s Never Seen" - Pink Sheet, 17 Jan, 2017.)