Today's Article
The federal agency
that oversees public
health barely
monitors its own
investigative
activities, according
to the GAO.
that oversees public
health barely
monitors its own
investigative
activities, according
to the GAO.
The American Spark
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FDA Needs To Improve Oversight Of Investigations, Says Study
By Cliff Montgomery - Mar. 4th, 2010
The federal agency that oversees public health barely monitors its own investigative activities, according to a
recent report from the Government Accountability Office (GAO).
Below, The American Spark quotes from the study's highlights:
"The Food and Drug Administration (FDA) is responsible for protecting public health by regulating products
such as prescription drugs and vaccines and has the authority to investigate alleged criminal activity related to
FDA-regulated products, for example on the sale of counterfeit drugs.
"Within FDA, the Office of Criminal Investigations (OCI) investigates individuals and companies external to
FDA. FDA also has the authority to investigate allegations of FDA employee misconduct and these internal
investigations are conducted by the Office of Internal Affairs (OIA), a distinct office within OCI."
"Although OCI maintains policies to guide its investigations, FDA’s oversight of OCI’s investigations of
individuals and companies external to FDA is limited.
"As a key element of FDA’s oversight of OCI, FDA’s assessment of OCI’s six field offices is intended to ensure
compliance with investigative policies; however, the assessments are not being implemented in accordance
with prescribed time frames. Of the 24 total office assessments that should have been completed by August
2009, only 7, or about 30 percent, were completed-- and one office had not been assessed in over 10 years.
"In addition, FDA lacks performance measures that could enhance the agency’s oversight by allowing it to
assess OCI’s overall success.
"The OCI Director meets weekly with a senior official in the Office of Regulatory Affairs (ORA), the office in
which OCI is located; but OCI is not required to report specific information to ORA or other FDA senior-level
offices as part of its formal reporting relationship. As a result, FDA depends on OCI’s Director to determine
what aspects of OCI’s investigations should be communicated to FDA senior managers.
"According to a senior ORA official, OCI operates more autonomously than other offices within ORA, in part,
because of OCI’s unique role and expertise within FDA.
"Similar to OCI, OIA has policies in place to guide its internal investigations, but FDA’s oversight of OIA’s
investigations of FDA employees is limited. [...] FDA does not have a requirement for OIA to report specific
information to...FDA senior-level offices on its investigative activities, or a process in place to routinely monitor
OIA’s compliance with its investigative policies.
"The OIA manager told GAO that the number of investigations is such that he is generally involved in all of
them, and can therefore review investigative documents before closing cases to assess compliance with
investigative policies. The OIA manager told GAO that his review alleviates the need for a process to monitor
compliance with OIA’s investigative policies.
"[But] The potential effectiveness of this review is limited because it relies on the OIA manager, who is also
responsible for supervising investigations."
What GAO Recommends
"To improve oversight of its investigations, GAO recommends that FDA regularly monitor OCI, and [also]
establish a process to monitor OIA for compliance with its investigative policies.
"GAO [further] recommends that FDA establish performance measures for OCI, to assess whether OCI is
achieving its desired results.
"FDA agreed with GAO’s recommendations."
Like what you're reading so far? Then why not order a full year (52 issues) of The American Spark
e-newsletter for only $15? A major article covering an story not being told in the Corporate Press will be
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By Cliff Montgomery - Mar. 4th, 2010
The federal agency that oversees public health barely monitors its own investigative activities, according to a
recent report from the Government Accountability Office (GAO).
Below, The American Spark quotes from the study's highlights:
"The Food and Drug Administration (FDA) is responsible for protecting public health by regulating products
such as prescription drugs and vaccines and has the authority to investigate alleged criminal activity related to
FDA-regulated products, for example on the sale of counterfeit drugs.
"Within FDA, the Office of Criminal Investigations (OCI) investigates individuals and companies external to
FDA. FDA also has the authority to investigate allegations of FDA employee misconduct and these internal
investigations are conducted by the Office of Internal Affairs (OIA), a distinct office within OCI."
"Although OCI maintains policies to guide its investigations, FDA’s oversight of OCI’s investigations of
individuals and companies external to FDA is limited.
"As a key element of FDA’s oversight of OCI, FDA’s assessment of OCI’s six field offices is intended to ensure
compliance with investigative policies; however, the assessments are not being implemented in accordance
with prescribed time frames. Of the 24 total office assessments that should have been completed by August
2009, only 7, or about 30 percent, were completed-- and one office had not been assessed in over 10 years.
"In addition, FDA lacks performance measures that could enhance the agency’s oversight by allowing it to
assess OCI’s overall success.
"The OCI Director meets weekly with a senior official in the Office of Regulatory Affairs (ORA), the office in
which OCI is located; but OCI is not required to report specific information to ORA or other FDA senior-level
offices as part of its formal reporting relationship. As a result, FDA depends on OCI’s Director to determine
what aspects of OCI’s investigations should be communicated to FDA senior managers.
"According to a senior ORA official, OCI operates more autonomously than other offices within ORA, in part,
because of OCI’s unique role and expertise within FDA.
"Similar to OCI, OIA has policies in place to guide its internal investigations, but FDA’s oversight of OIA’s
investigations of FDA employees is limited. [...] FDA does not have a requirement for OIA to report specific
information to...FDA senior-level offices on its investigative activities, or a process in place to routinely monitor
OIA’s compliance with its investigative policies.
"The OIA manager told GAO that the number of investigations is such that he is generally involved in all of
them, and can therefore review investigative documents before closing cases to assess compliance with
investigative policies. The OIA manager told GAO that his review alleviates the need for a process to monitor
compliance with OIA’s investigative policies.
"[But] The potential effectiveness of this review is limited because it relies on the OIA manager, who is also
responsible for supervising investigations."
What GAO Recommends
"To improve oversight of its investigations, GAO recommends that FDA regularly monitor OCI, and [also]
establish a process to monitor OIA for compliance with its investigative policies.
"GAO [further] recommends that FDA establish performance measures for OCI, to assess whether OCI is
achieving its desired results.
"FDA agreed with GAO’s recommendations."
Like what you're reading so far? Then why not order a full year (52 issues) of The American Spark
e-newsletter for only $15? A major article covering an story not being told in the Corporate Press will be
delivered to your email every Monday morning for a full year, for less than 30 cents an issue. Order Now!
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