GAO Identifies Gaps in Office of International Programs
US Food and Drug Administration (FDA) Commissioner Ned Sharpless “should assessthe effectiveness of the foreign offices’ contributions,” a Government Accountability
Office (GAO) report recommended.
GAO’s report called attention Thursday to priority recommendations on FDA’s parent
agency, the US Department of Health and Human Services (HHS). As the agency
continues testing performance metrics and evaluating the strategic workplan of its
Office of International Programs (OIP), FDA’s acting commissioner was directed to
systematically track data and measure whether OIP’s activities are specifically
targeting drug safety-related issues, such as inspections, import alerts and warning
letters.
HHS agreed with this FDA-specific recommendation. “FDA plans to conduct internal
annual reviews of its foreign offices’ performances and track their contributions by
type of commodity.” GAO set forth actions aimed at addressing issues and concerns
it deemed priorities in the report.
FDA has since developed new performance measures for foreign offices along with a
monitoring and evaluation plan. To address GAO’s recommendation, FDA intends to
then assess the effectiveness of its foreign offices’ contributions. This assessment is
to be carried out by systematically tracking whether offices’ activities contribute to
drug safety-related outcomes, such as inspections, import alerts and warning
letters.
FDA will conduct the assessment in fiscal 2019. “We will assess these actions once
they have been completed. Protecting public health via enhanced oversight of
medical products” is a high-risk area.
Other FDA-specific recommendations laid out on the new GAO report relate to
improved food oversight.