FDA officials said Thursday they won't expedite the review of manufacturing changes Boston Scientific needs to make to help it resume selling its implantable heart defibrillators.
Boston Scientific recalled its ICDs this month after discovering it hadn't received FDA approval for manufacturing changes, the Wall Street Journal reports. Although sales representatives are saying the review will take fewer than the typical 30 days, FDA officials said in an interview that they have given Boston Scientific's applications a preliminary look and the submissions appear to be in order. But the officials said the agency hasn't begun an in-depth review of the material and the company will have to wait its turn.
Healthcare analysts at Leerink Swann--citing a doctor who had spoken with Boston Scientific sales reps--said only minor manufacturing process changes led to the company pulling its inventory, MedCity News reports. First, the company failed to tell the FDA that it had added a supplier for one of its ICD components; and second, it had changed a process to make it identical to a process for its pacemaker devices, according to the unnamed physician.
Other companies could benefit from Boston Scientific's woes. Earlier this week, Credit Suisse analyst Kristen Stewart wrote a note describing how a majority of 63 electrophysicologists surveyed by the firm expressed "A fair amount of skepticism [...] as to whether all details were disclosed about the shipping hold and product retrieval," and that "many expressed concerns that it could be a deeper issue," Barron's notes.
- check out WSJ's coverage
- see Barron's take
- read MedCity News' report