According to Forbes, the announcement confirmed rumors that had been circulating for at least two weeks, though in the press release the company said it had just been informed of the investigation on October 26. No details were disclosed about the investigation.
The company also said that it believed that the FDA would begin a review to possibly reclassify its Impella devices as Class III devices, which would require FDA clearance using the more stringent premarket approval (PMA) process instead of the current, less demanding 510(k) premarket notification process.
This is not the first time Abiomed has run into trouble with the FDA. In June 2011 Abiomed received a warning letter from the FDA about improper marketing of Impella for unapproved indications.
The letter cited various statements and advertisements that according to the letter represented “a major change or modification in the intended use of your firm’s device that requires a new premarket notification.”
In December 2010 the company issued a press release announcing– and spinning– the results of the PROTECT II trial comparing Impella to the intra-aortic balloon (IAB) in high risk PCI patients. Although the trial was stopped early for futility, the press release downplayed the negative findings and instead emphasized positive trends and encouraging subgroup analyses. Last month, when the trial was finally published in Circulation, the company issued a much more restrained press release, perhaps a reflection of the company’s efforts to avoid further problems with the FDA.
Abiomed’s press release stated, “On October 26, 2012, Abiomed was informed that the United States Attorney’s Office for the District of Columbia is conducting an investigation that is focused on the Company’s marketing and labeling of the Impella 2.5. On October, 31, 2012, Abiomed accepted service of a Health Insurance Portability and Accountability Act administrative subpoena related to this investigation. The subpoena seeks documents related to the Impella 2.5 and we understand the investigation focuses primarily on marketing and labeling issues. Abiomed is in the process of responding to the subpoena and intends to cooperate fully.”
The press release also stated that the company believes that the Food and Drug Administration (FDA) 515 Program Initiative will hold an Advisory Panel in early December 2012 to review the classification determination of “intra-aortic balloon and control systems,” and “nonroller-type cardiopulmonary bypass blood pumps,” which includes Impella products. Since this has not been formally announced by the FDA, this estimated timing is subject to change.
Abiomed is in the process of responding to the subpoena and intend to cooperate fully.
Whether because of the DOJ investigation or the FDA announcement, the stock price of Abiomed dropped 25% with the news.