Pfizer ‘disappointed’ with US FDA outcome at ex-Hospira plant
When Pfizer acquired Hospira for $17bn (€15.5bn) in 2015, the firm said it was “comfortable” addressing problems at a number of manufacturing facilities which had seen a long string of product recalls, Form 483s, and warning letters (see related news stories below).
And while reporting its first quarter 2017 results this week, management reflected on the latest regulatory slap to the former Hospira network, a US Food and Drug Administration (FDA) warning letter sent in February to the McPherson, Kansas facility now part of Pfizer’s contracting manufacturing business CentreOne.
“We're obviously disappointed with the outcome of recent regulatory inspections at some of our manufacturing facilities, including McPherson,” said John Young, president of Pfizer Essential Health during the call (transcript here).
He added since the letter, Pfizer has implemented corrective and preventive actions to address issues identified by the FDA and the firm is “making all the investments necessary to satisfy the items identified during the recent inspections, and our goal is to have these issues remediated in a timely fashion.”
This includes both capital investments and “exchanging experiences and capabilities across the whole of the Pfizer network,” he added.
CEO Ian Read pointed out the inspection at McPherson occurred within the first nine months of the Hospira acquisition (May 16 to June 8, 2016), and Pfizer has made some progress since.
“The data in the 483s are based on a view of the plan as a year and a half ago or year ago. So we have made progress. We continue to make progress. And we believe that our plans to rectify those observations are well underway.”
The site does the fill/finish of Momenta Pharmaceuticals Glatopa, a generic version of Teva’s multiple sclerosis bestseller Copaxone (glatiramer acetate injection), and the warning letter delayed an FDA decision to approve a 40mg version submitted by Momenta partner Sandoz.
For the first quarter 2017, Pfizer reported total revenues of $12.8bn, down 2% year-on-year.
