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GAO High Risk List Items FY 2012 OPA


Table of Contents FY 2012 OPA

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. 


Five Major GAO Concerns

  1. Improving legislative authorities
  2. Streamlining regulatory jurisdiction with other agencies
  3. Improving recall implementation
  4. Expanding inspectional capacity
  5. Improving interagency coordination     

FDA Actions:

  1. Improving legislative authorities
    1. Food Safety Modernization Act of 2010 was signed into law on January 4, 2011.
  2. Streamlining Jurisdiction
    1. President’s Food Safety Working Group
    2. FDA & National Oceanic and Atmospheric Administration (NOAA)  have Memorandum of Understanding (MOU)
    3. Ongoing work with USDA

                                                              i.      Better coordination on eggs

  1. Improving recall implementation
    1. New legislation provides mandatory authority
    2. Reportable Food Registry in effect
    3. www.foodsafety.gov with national reach for consumers
    4. Petnet system for pet recalls under development; pet widget launched
    5. Transparency proposal
  2. Expanding Inspectional Capacity
    1. Funding increases permitted hiring more than 700 investigators between FY 2007 and FY 2009, and an additional 274 in FY 2010. Food inspections now increasing.
    2. Risk-based inspectional plan
    3. PREDICT for imports – deployed in Los Angeles, New York, Seattle and San Francisco – and now starting to deploy further after delays
    4. National egg inspection plan: 600 largest egg facilities by end of CY 2011
    5. Partnerships – significant work on integrated food safety system with states and localities
  3. Improving Interagency Coordination
    1. Food Safety Working Group
    2. Coordinated incident response team

                                                              i.      Example: egg recall

    1. Federal, state and local system planning


More information about specific milestones the agency will accomplish to achieve this goal can be found here:

Transforming Federal Oversight of Food Safety

Issue – Protecting Public Health through Enhanced Oversight of Medical Products 

The Food and Drug Administration (FDA) ensures the safety and effectiveness of medical productsdrugs, biologics, and medical devices marketed in the United States, whether they are manufactured in domestic or foreign establishments. The agency's responsibilities begin long before a product is brought to market and continue after a product's approval. In recent years FDA's responsibilities have grown with the passage of laws containing new requirements, the complexity of products submitted to FDA for approval, and the globalization of the medical products industry. Many, including FDA's own Science Board and the National Academy of Sciences' Institute of Medicine have questioned FDA's ability to continue to adequately fulfill its mission.


Six Major GAO Concerns

  1. Inspecting foreign manufacturers
  2. Monitoring postmarket safety
  3. Reviewing promotional materials for medical products
  4. Overseeing clinical trials
  5. Ensuring that high-risk types of medical devices are approved through the most stringent premarket review process
  6. Establishing basis for assessing resource needs


FDA Actions

  1. Inspecting foreign manufacturers

        Improving data systems:  electronic registration of device and drug manufacturers

        Increased coordination and data sharing with foreign regulatory authorities

        New dedicated foreign inspection staff (2/09)

        Voluntary audit submission

        Policy analysis on supply chain weaknesses

        2010 GAO report on foreign drug inspections acknowledges that FDA has increased its rate of foreign inspections and improved the data systems it uses to manage its  foreign inspection program

  1. Monitoring Postmarket Safety

        Transformed system of monitoring postmarket commitments

        Under Food and Drug Administration Amendments Act of 2007, FDA can now require postmarket studies

        Sentinel system expanding

        Major external review of FDA systems for adverse event reports and epidemiological analyses planned

        Institute of Medicine (IOM) report on using data for postmarket safety decision-making

  1. Reviewing promotional materials for medical products

        New tracking of responsiveness to advance submissions

        Outreach to help professionals report false or misleading promotions

          “Bad Ad Campaign”

        Cross-agency review of advertising and promotion activities

  1. Overseeing clinical trials

        Revamped debarment and disqualification procedures

        Number of debarment actions has risen considerably and times for resolving both disqualification and debarment actions have been reduced significantly

        Series of new guidances and regulations to strengthen FDA oversight

        Clinical Trials Transformation Initiative underway

        New Good Clinical Practice coordination effort with European agency (EMEA) 9/09

  1. High Risk Medical Devices

        This was a FY 2010 strategic priority for Center for Devices and Radiological Health

        August 25, 2010 proposed rule will require the filing of a Premarket Approval notice of completion of a product development protocol for four class III preamendments device types identified by GAO

        This proposed rule represents the most recent of FDA’s efforts to address the 25 device types identified in GAO’s 2009 report

  1. Assessing Resource Needs

        Booz Allen just completed resource estimation study that addresses GAO-identified gaps

        FDA reviewing results of study and will be able to brief GAO at a later time


FDA Assessment

          Major challenges still facing food and medical product safety

          Substantial initiatives underway to address gaps

          Progress in many areas


More information about specific milestones the agency will accomplish to achieve this goal can be found here:

Report to Committee on Appropriations: Report on FDA’s Approach to Medical Product Supply Chain Safety     

Safety First Mission: To put into place the policies, procedures, practices, and technology needed to fulfill CDER's enhanced mission of ensuring drug safety throughout the drug lifecycle by giving pre-marketing drug review and post-marketing safety an equal focus.

Running Clinical Trials

CDRH Plan of Action for 510(k) and Science   


Next page: Discontinued Goal Table FY 2012 OPA