Opinion ID: 2777754
Heading Depth: 4
Heading Rank: 2

Heading: The June 2011 Warning Letter

Text: Over a year later, on June 10, 2011, the FDA issued an official Warning Letter to Abiomed stating that the company's marketing materials continued to improperly compare the Impella 2.5 to the IABP and promote the device for non-cleared uses. A Warning Letter is a step above an Untitled Letter in the FDA's enforcement hierarchy. It communicates that the FDA believes the regulated entity has committed a violation of regulatory significance but does not commit the FDA to taking enforcement action. Simon, 2014 WL 1413638, at  n.2 (citing U.S. Food & Drug -9- Admin., Regulatory Procedures Manual: Advisory Actions, 2004 WL 3363386, at -2 (2010)). The Warning Letter criticized an Abiomed magazine advertisement that pictured a hand puncturing a red balloon and suggested that the Impella 2.5 was superior to the IABP for circulatory support in the Cath lab. The FDA's letter also complained about the Abiomed slogan, Recovering Hearts, Saving Lives, which the FDA stated would require a study under an IDE to evaluate whether the device could salvage heart tissue and muscle.3 Finally, the agency took issue with a claim at a conference of cardiovascular physicians that the Impella could improve hemodynamics and cardiac output in AMI Shock patients, since those indications also needed to be supported with a study performed under an IDE. The Warning Letter was posted on the FDA's website. An Abiomed spokeswoman stated publicly that the letter addresses specific promotional items from 2010. . . . We are working with the FDA to ensure all of our promotional materials comply with the agency moving forward. According to CW1, however, Abiomed senior management did not take the warning letter seriously and trivialized the FDA concerns. CW2, a senior quality compliance 3 The FDA subsequently revised its position on the slogan, stat[ing] that [it] had decided to leave the tagline issue alone and asking only that the company not claim that the Impella 2.5 could Recover Heart Muscle. -10- and validation engineer at Abiomed from April 2008 through March 2011, likewise said that Abiomed 'didn't change anything' after being notified by the FDA. In July 2011, at Abiomed's request, the FDA held a clarification call with Abiomed to discuss the Warning Letter. The FDA reminded Abiomed of the Impella 2.5's very limited clearance and told them to refrain from comparing the device to the IABP. One agency member noted that Abiomed should have had some awareness of the issues given the January 2010 Untitled Letter. In August 2011, Abiomed sent a formal response letter to the FDA discussing the actions it had taken to address the FDA's concerns. The company stated that it would not run the balloon advertisement again and would ensure that the advertisement did not exist on Abiomed's website, and that it had removed materials related to the cardiovascular conference from the website. The letter also stated that Abiomed would put into place a plan to prevent future violations. Abiomed did not receive any follow-up correspondence from the FDA for several months.