Opinion ID: 2777754
Heading Depth: 4
Heading Rank: 1

Heading: The January 2010 Untitled Letter

Text: On January 28, 2010, the FDA sent Abiomed an Untitled Letter objecting to certain of Abiomed's activities promoting the Impella 2.5. Untitled Letters are intended to address alleged regulatory violations that do not meet the threshold for regulatory significance warranting a Warning Letter. They do[] not include a warning that a company's failure to take prompt corrective steps could lead to an enforcement action. Simon, 2014 WL 1413638, at  n.2 (citing U.S. Food & Drug Admin., Regulatory Procedures Manual: Advisory Actions, 2004 WL 3363386, at  (2010)). The FDA stated that Abiomed had improperly promot[ed] the Impella 2.5 for high risk PCI and AMI and represented that the Impella 2.5 was superior to the IABP in those uses. Essentially, in the FDA's view, Abiomed's promotional materials represented that the device was effective for uses for which it was being tested under the Protect II and Recover II IDEs, which constituted a violation of FDA regulations. -8- Abiomed responded to the FDA letter on March 4, 2010, stating that it now recognize[d] that the challenged promotions had made improper efficacy claims and that it would revise its marketing materials in order to remove the offending statements. Abiomed also represented that it had strengthened its review process for promotional materials. The FDA viewed this response as inadequate, however, and Abiomed made further changes to its advertisements and reviewed its marketing materials and website to ensure that there were no other materials beyond those identified by the FDA that made improper safety or efficacy claims. On April 20, 2010, the FDA wrote Abiomed stating that its response appear[ed] adequate and that no further action was necessary. Abiomed did not publicly disclose this correspondence with the FDA at that time.