Dive Brief:
- BD plans to submit an updated 510(k) filing to the FDA for its Alaris infusion pump in the late second fiscal quarter or possibly third fiscal quarter of 2021, representing a delay of around six months. The company, which is seeking clearance for the system taking into account a new version of software and recall remediation, had planned to make its submission to the FDA for the infusion pump in the fourth quarter of 2020.
- SVB Leerink analysts in a Friday note described BD's management as having "much better visibility into submission timing now" compared to in May when the company announced the initial delayed submission timeline due to the COVID-19 pandemic and issuance of an FDA Form 483, a signal of a potential violation observed during an inspection, at one of its facilities.
- CEO Tom Polen told investors during Thursday's fiscal third quarter earnings call that BD is "working diligently and with urgency" on the 510(k) filing as the company continues testing and ongoing discussions with the agency.
Dive Insight:
It's been a slower road than BD expected in fixing problems found with its Alaris infusion pumps. FDA in early March reported certain infusion pump systems recalled by BD on Feb. 4 had resulted in 55 injuries and one death. Additionally, last week the company issued an urgent field safety notice to customers, posted by the U.K. Medicines and Healthcare products Regulatory Agency, regarding six "potential situations" involving Alaris components that could pose risk.
BD has been working for months with the FDA to address features of the Alaris products and has recorded a charge of about $200 million for the estimated future costs of the remediation effort. However, that's a moving target and the company's costs could increase over time.
Nonetheless, Polen on Thursday's earnings call said that BD is "very confident in the safety of the Alaris product" and gave investors an update on system testing. He contends that the additional time spent on the test protocol will ultimately result in a quicker FDA review and clearance process.
BD has completed "quite a bit of the testing" and other requirements for the company's 510(k) submission, Polen said, including 100% of formative testing of 12 different human factor tests and software system verification.
Polen also called out the fact that BD has completed a "retrospective risk assessment" of every change that's been made to the Alaris system since its initial 510(k), which he said should result in the "retiring" of significant risk to the company's updated submission.
