Press Release

FDA Port of Entry Investigation Stats Suggest More Emphasis Needed on the Importation of Opioids


11.01.18

WASHINGTON, D.C. – Earlier this Congress, the Energy and Commerce Committee received responses to questions posed to the Food and Drug Administration (FDA) regarding Port of Entry (POE) investigations, specifically the Office of Criminal Investigation’s (OCI) actions to combat the opioid crisis, and stop the importation of illegal opioids and other harmful products through international mail facilities. These important enforcement actions were recently strengthened and new tools provided to law enforcement in the landmark bill H.R. 6, the SUPPORT for Patients and Communities Act, written by Energy and Commerce Chairman Greg Walden (R-OR), which recently became law.

The committee requested information on POE cases, as well as Foreign Unapproved Medical Products (FUMP) cases, opened in FY 2017 and FY 2018 (as of July 2018) by OCI. The FDA provided a variety of information regarding the numbers of cases opened by the OCI, including noting that only about 10% of the 506 POE cases opened in Fiscal Years 2017 and 2018 related to opioids, including fentanyl and kratom, and none of those cases were reported by either the New York, or Los Angeles field offices. Additionally, of the 506 cases opened by OCI, 415 – or 82% of them, were investigations into FUMP importation.

The FDA also addressed the lack of a Director of the OCI, simply stating that a vacancy announcement had been posted on May 23, 2018, more than one year after the vacancy had been created in January of 2017. In response to the committee’s request for a proposed timeline for the position to be filled, the FDA responded that they are working through the review and selection process, and that recruiting a director is a top priority.

The FDA letter did not address any arrangements or memoranda of agreement it may have with Homeland Security Investigations (HSI) or any intentions they have of creating such arrangements, though that information had been requested by the committee.

In addition to the information provided by FDA in this letter, emails provided to the committee show that there was a decrease in the number of cases administratively closed by OCI management from 34% in FY 2017 to 8% in FY 2018, and a direct cause for that decrease could not be accounted for. We look forward to continuing to work with the FDA to provide additional resources and support – in addition to those recently provided in H.R. 6 – to ensure dangerous, illicit drugs are not entering the United States through ports of entry and the international mail system.

To read the responses by the FDA click HERE.

To read the letter sent to the FDA by the committee, click HERE.

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Press Release