FY 2017 Annual Performance Plan and Report

GAO High Risk Items

The Government Accountability Office (GAO) has placed four HHS programs (listed below) on its “High Risk List,” which lists programs that may have greater vulnerabilities to fraud, waste, abuse, and mismanagement.  As a responsible steward to taxpayer resources, HHS is committed to making improvements related to these challenges and high risk areas.

The programs identified by GAO are:

CMS - Medicare Program

CMS - Medicaid Program

FDA - Improving Federal Oversight of Food Safety

FDA - Protecting Public Health through Enhanced Oversight of Medical Products

To read about HHS’s progress toward addressing these high-risk items, find the 2015 GAO High-Risk Series Update here: http://www.gao.gov/assets/670/668415.pdf.

CMS Plan for High Risk Items

A copy of the CMS plan for addressing risk within Medicare and Medicaid programs is available at: http://www.cms.gov/apps/files/2015_CMS_GAO_High_Risk_Program_Report.pdf

FDA Plan for High Risk Items

Issue – Transforming Federal Oversight of Food Safety

According to the recent CDC study, each year, about 48 million people contract a food borne illness in the United States, about 128,000 require hospitalization, and about 3,000 die.  GAO has stated that the fragmented U.S. system of oversight has caused inconsistent oversight, ineffective coordination, and inefficient use of resources.

Major GAO Concerns and FDA Actions

1. In December, 2014, GAO recommended that
   1. HHS and USDA build upon their efforts to implement GPRAMA requirements to fully address crosscutting food safety efforts.
      1. HHS agreed with the recommendation and will continue to build upon its efforts to implement GPRAMA requirements to address crosscutting food safety efforts, by expanding its strategic and performance planning documents along with working with other agencies to achieve food safety-related goals and objectives.  HHS will draft revised descriptions in its strategic plan to fully address crosscutting food safety efforts and inter-agency collaborations. 
      2. Moreover, the Food Safety Modernization Act (FSMA) envisions collaborations among federal and state agencies on food safety standard setting, technical assistance, and compliance.  Ongoing collaborations among the three primary Departments responsible for food safety and food defense – HHS, the United States Department of Agriculture, and the Department of Homeland Security – has strengthened the food safety system in areas of research, risk assessment, and food defense. 

1. In 2014, GAO also recommended that Congress should consider
   1. directing OMB to develop a government-wide food safety performance plan and
   2. formalizing the FSWG through statute to help ensure sustained leadership across food safety agencies over time.

Issue – Protecting Public Health through Enhanced Oversight of Medical Products

The FDA has the vital mission of protecting the public health by overseeing the safety and effectiveness of medical products—drugs, biologics, and medical devices—marketed in the United States.  The agency’s responsibilities begin long before a product is brought to market and continue after a product’s approval, regardless of whether it is manufactured here or abroad.  In recent years, FDA has been confronted with multiple challenges.  Rapid changes in science and technology, globalization, unpredictable public health crises, an increasing workload, and the continuing need to monitor the safety of thousands of marketed medical products have strained the agency’s resources.

Major GAO Concerns and FDA Actions

1. Strengthen the Drug Shortage Program

• FDA created an Intra-Agency drug shortages task force to enhance agency activities on drug shortages.
• FDA sponsored a public workshop on September 26, 2011, to provide information for, and to gain additional insight from, professional societies, patient advocates, industry, consumer groups, health care professionals, researchers and other interested persons about the causes and impact of drug shortages and possible strategies for preventing and mitigating drug shortages.  http://www.fda.gov/drugs/newsevents/ucm265968.htm
• FDA published a Strategic Plan for Preventing and Mitigating Drug Shortages on October 31, 2013, as required by the Food and Drug Administration Safety and Innovation Act (FDASIA) enacted July 9, 2012.  This plan contains the Agency’s short term and longer term plans for preventing and mitigating shortages.  http://www.fda.gov/downloads/drugs/drugsafety/drugshortages/ucm372566.pdf
• FDA published the first Annual report to congress as required by FDASIA.  http://www.fda.gov/drugs/drugsafety/drugshortages/ucm384891.htm
• The FDASIA requirement for manufacturers to notify FDA of potential supply disruptions has resulted in a sustained increased level of notifications, and allows FDA to prevent shortages in many cases.  Shortages decreased from 117 new shortages in 2012 to 44 new shortages in 2013.
• FDA has developed a new data system to enhance our ability to track drug shortages.  The new data system includes strengthened internal controls, and will allow FDA to better analyze trends in drug shortages, as well as to assess its performance in mitigating and preventing shortages, through the use of some potential metrics that were included in the FDA Annual Report to Congress.

1. Conduct more inspections of foreign establishments manufacturing medical products for the U.S. market and take a risk-based approach in selecting foreign drug establishments

• In November 2008, the agency began posting FDA employees in foreign posts in key locations overseas.  FDA has opened offices in several countries where FDA presence can improve product safety and quality, and leverage resources.  To date, FDA has offices in India (Mumbai and New Delhi), China (Shanghai, Guangzhou, and Beijing), Europe (Brussels, Belgium), and Latin America (San Jose, Costa Rica; Santiago, Chile; and Mexico City, Mexico), and plans for a Middle East office.  FDA has investigators posted in Mumbai, Shanghai, and Guangzhou.  The establishment of foreign offices has enabled FDA to enhance its relationships with foreign counterpart regulatory officials to obtain more accurate and robust information about foreign drug establishments and has facilitated FDA access to drug establishments for inspection.
• The agency also has established a specialized foreign cadre of investigators located in FDA district offices in the United States who are dedicated to foreign inspection assignments.  Now in its second year, the program has 15 investigators and has already significantly increased the number of foreign inspections.
• FDA has substantially increased its collaboration with foreign regulatory authorities.  For example, FDA participates in the API Pilot Program with the European Medicines Agency (EMA) and Australia’s Therapeutic Goods Administration (TGA), which calls for participants to share information, as permitted by law, about API inspections and to use this information to leverage the inspectional resources of each regulatory body.
• FDA has replaced the old drug registration and listing system, which relied on cumbersome manual entry , with the electronic drug registration and listing system (eDRLS).  With eDRLS, it is mandatory for all drug establishments shipping drugs to the United States to register with FDA electronically.  The implementation of eDRLS helps FDA quickly assemble information about drug establishments and since eDRLS is updated daily, FDA’s import entry reviewers have near real-time access to registration information and the ability to quickly flag unregistered foreign firms and unlisted drugs when offered for importation at ports and borders.
• FDA substantially has increased its inspection capacity, improved its databases and expanded its infrastructure to increase its global presence.