OIG Says FDA Needs More Supply Chain Authority
The FDA should seek authority from Congress to require drug companies to disclose the “complete physical path” of products through the supply chain, HHS Office of Inspector General (OIG) recommended in a new report.
The OIG looked at 44 drug products, tracing them backwards through the supply chain from dispenser to manufacturer, and found that the ownership of seven could not be completely traced using the information currently required by the Drug Supply Chain Security Act (DSCSA).
For 21 of the drugs, the OIG could not identify the shipping locations of trading partners or their third-party logistics providers. That information is not currently required by DSCSA — and the inspector general’s office said this could cause problems during a drug safety emergency.