Saturday 24 March 2018

Joint FDA-EMA Inspection Program Launches; Lessons for PIP Scandal

Beginning this month the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) will begin sharing facility inspection data in their respective territories  to make better use of resources and reduce drugmakers’ inspection burdens (click here to read the full news release).  The new collaboration comes on the heels of a pilot inspection program the agencies have been trialling the past few years.  According to the results released in August, the trial program has reduced the number of duplicate inspections and established a master list of active pharmaceutical ingredient supply facilities.  According to a document issued by the FDA and EMA earlier this month, the general approach will be to focus on information exchange for sites already known to each authority that have a history of satisfactory GMP compliance following previous inspections.

Sharing inspection data is part of a broader trend by the FDA to monitor foreign facilities. Under current programs the FDA will inspect foreign manufacturers who import into the US as well as evaluate imported products at the port of entry using its new PREDICT system.

As the Poly Impant Prothese (PIP) scandal involving breast implants continues to unfold expect greater information sharing and harmonization between US and EU authorities. This is in large part because the US FDA denied PIP’s request to distribute its breast implants in the US after its evaluation found insufficient evidence to determine they were safe. Reuters is reporting the FDA sent an inspector to PIP’s plant in France, who found multiple violations of accepted manufacturing practices and determined the products to be “adulterated.”

It be difficult for EU officials to explain why a US denial of the PIP device did not lead to a more stringent review. In future cases such findings will likely have ramifications for CE (European) certification and distribution of a device. In the end the FDA-EMA program and the PIP scandal will make it increasingly difficult for a FDA denial or report against a EU medical device to not have some consequences for the manufacturer.

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