US medical devices maker Boston Scientific Corporation suffered a serious setback as the US Food and Drug Administration (FDA) has refused to expedite the review of its implantable defibrillator manufacturing operations, the sales of which it had voluntarily suspended earlier this month. (See: Boston Scientific suspends sales of seven defibrillators)
The FDA has refused to hasten the review and is adhering to its 30-day schedule for reviewing the Natick, Massachusetts-based Boston Scientific's recall this month of its implantable defibrillators after failing to inform federal regulators about changes made in the manufacturing of its best-selling devices.
To make matters worse, the Department of Justice (DoJ) and the Securities and Exchange Commission (SEC) are investigating the recall, The Wall Street Journal reported today citing an internal company memorandum.
According to the memo, the paper said, the DoJ and the SEC investigators are seeking company documents regarding the company's discovery that it failed to obtain prior FDA approval, or communicate with regulators, physicians and stock analysts about the withdrawal.
Investigators are also seeking reports of injuries, the memorandum said, adding that an informal inquiry indicates an early-stage investigation by the SEC.
Boston Scientific had stopped shipment and had recalled unused units of all its implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy defibrillators (CRT-Ds) early this month.