Two weeks after hastily yanking its entire field inventory of implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators, Boston Scientific Corp. (NYSE:BSX) officials broke their silence in a series of conference calls with physicians.
BSX CEO Ramond Elliot said the company filed a 30-day notice with the Food & Drug Administration March 15 and 16 and confirmed reports that the FDA will not be expediting its review.
“As you have also probably heard, FDA indicated last week that it is not taking steps to expedite review of our applications,” Elliott said, according to the script for the March 29 calls.
“It appears we will have to wait our turn in the queue. We certainly respect the FDA and its internal review processes,” he said.
Elliot also detailed the reasons for the shipment hold, confirming that the problems were related to small changes in its manufacturing process and a new vendor.
“In the first case we were using the same cleaning process for our defibrillator and pacemaker manufacturing lines, but with different cycle times. When we decided to standardize to the same cycle time for both, we failed to file the defibrillator process change for approval with the FDA. In the second case we filed for approval of a secondary supply vendor, but we did not submit qualification data for a subcomponent provided by the vendor,” Elliott explained. “In both cases, the manufacturing changes were fully validated and met the stringent requirements of our own internal quality system. We simply failed to file the required documentation with the FDA.”
Elliot expressed regret over the pullback and apologized to physicians.
“The action that we initiated on March 15 has been difficult for everyone. No one wants to have to go through these actions or to be impacted by them. We understand this and apologize for the inconvenience we have caused. We understand the impact on all parties: Physicians, the patients they serve, and our employees. The decisions that Boston Scientific has made and will continue to make are rooted in our commitment to comply with all Legal and Regulatory requirements, as well as our guiding principles of doing the RIGHT THING every day.”
Hank Kucheman, executive vice president and group president of BSX’s newly formed Cardiology, Rhythm and Vascular business, expressed confidence that the company had the financial wherewithal to withstand any blow back from the shipment hold. The hold is costing Boston Scientific an estimated $5 million a day.
“You should feel confident that Boston Scientific is on solid ground financially. We will weather this storm and will be here to support you and your patients for the long term,” Kucheman said.
The executives re-iterated that the changes to the manufacturing process did not affect patient safety and that the hold applies to U.S. sales only. The devices are still available overseas, they said.