Opinion ID: 2777754
Heading Depth: 4
Heading Rank: 5

Heading: The August 2012 Meeting with the FDA and

Text: Subsequent Compliance Audits On August 7, 2012, the FDA and Abiomed met again, again at Abiomed's request. [T]he primary objective of the meeting was to present Abiomed's actions to close-out the Warning Letter and maintain compliance and then have a discussion as to whether Abiomed was meeting FDA requirements. After Abiomed detailed the measures it was taking to ensure compliance with the regulations, an FDA representative suggested that Abiomed 'take a step back' because [h]e saw the corrective actions as too targeted, and not addressing the whole labeling program. Another representative commented that the FDA did not think of the clearances of the product in the same way Abiomed does. The FDA was frustrated because it felt that regulatory violations were happen[ing] repeatedly. Minogue responded that Abiomed had to comply, and will comply, but that, because Abiomed was such a small company, it was critical to market the device. An FDA representative opined that it would involve 'walking a fine line' to stay in compliance while marketing. The meeting closed with the FDA -14- admonishing Abiomed that it took the matter very seriously, that a Warning Letter is the last communication given, [and] that Abiomed needed to do a systemic review of its procedures in order to give the [agency] a systemic response for compliance. In the late summer of 2012, the FDA conducted a compliance audit of Abiomed, and Abiomed simultaneously conducted its own internal audit. After those audits, Abiomed pulled its marketing and training materials for compliance reasons and did not put up replacement materials for several months. The replacement materials, according to CW5, were extremely limited compared to what they had previously -- for example, they no longer included slides about the Protect II Study. Abiomed confirmed in a letter to the FDA dated August 20, 2012, that it understood its prior approach to compliance was too narrow in focus and so was adopting a broad, systemic approach to address the issues raised by FDA. This approach included destroy[ing] the Impella marketing brochures cited by FDA, stopp[ing] distribution of all marketing labeling, recall[ing] all marketing labeling held by Abiomed field personnel, and stopp[ing] any planned updates to all labeling and the [Abiomed] website.