FDA Shutdown Could Cause Major Delays to Approvals

The recent government shutdown will significantly impact upon FDA (American Food and Drug Association) services and operations, especially in the heart failure (HF) and arrhythmia markets, due to the agency’s limited proactive abilities for device approvals, according to an analyst with research and consulting firm GlobalData.

Robert Littlefield, MSc, GlobalData’s analyst covering Cardiovascular Medical Devices, expects the shutdown to significantly limit agency panel discussions, resulting in the indefinite postponement of meetings, which could in turn delay commercial launches and spook device company investors.

Nine separate FDA advisory committee meetings are already scheduled for this month, during which recommendations are expected to be made on devices indicated for use in patients with HF.

On Oct. 8, 2013, the committee will review information on the Premarket Approval (PMA) application for the expansion of sanctioned cardiac resynchronization therapy (CRT) indications for all approved Medtronic Cardiac Resynchronization Therapy-Pacemaker (CRT-P) and Medtronic Cardiac Resynchronization Therapy-Defibrillator (CRT-D) devices.

However, Littlefield states: “These review meetings require a significant amount of preparation, and we expect the government shutdown to hamper approval efforts or delay the meetings altogether, which would push back authorization of the expanded indications for Medtronic’s CRT devices.”

Medtronic currently controls approximately 42% of the international pacemaker / CRT-P market and 43% of the implantable cardioverter defibrillator (ICD) / CRT-D market.

Given the superiority of CRT over conventional treatment in many situations, especially in relation to the increasing prevalence of serious HF, Littlefield believes that the approval of expanded indications for the use of CRT could support significant revenue growth for Medtronic and help the company to maintain its cardiac rhythm management (CRM) market share in the US.

“Unfortunately, in contrast to the steady stream of regulations that the FDA normally churns out, it is doubtful that the agency will unveil any game-changing guidance documents or expanded-indication approvals with half of its staff on mandatory vacation,” Littlefield concludes.  

Source: GlobalData