Injectable drugmaker Hospira ($HSP) has a lot to juggle just now. It has big problems facing its infusion pump business but that doesn't mean issues in drug manufacturing have been resolved. It continues to issue product recalls. And it is feeling the need to ramp up production in the face of shortages of some of its products even as it is trying to upgrade its key drug manufacturing plant in the face of FDA concerns.
CEO F. Michael Ball Wednesday told analysts in a broadcast call that part of the answer is for the drugmaker to maintain a cadre of consultants that for months has been crawling over its Rocky Mountain, NC, plant, the facility that has been the main focus of FDA frustration. A recent re-inspection of the plant resulted in 20 more Form 483 observations. The drugmaker has already spent more than $375 million on remediation of its various plants but expects to spend another $75 million this year. "As I said, we've kind of doubled down on the consultants to make sure I'm covered on the remediation side," Ball said. "As we get the end in sight here, I do not want to drop the ball as the goal line's coming here."
Hospira, the largest maker of generic sterile injectables in the U.S., has been wrestling with problems as inspections since 2010 have found a long list of problems at Rocky Mount, as well as at facilities in Clayton, NC, and Austin, TX. The company has repeatedly had to recall products and adjust expectations for investors. It had three recalls of 5 products while inspectors were in the plant for the re-inspection, and the FDA have issued a couple more in the last week.
Ball's remarks followed an earnings report in which the drugmaker reported a $76 million loss for the first quarter after taking one-time charges tied to problems in its device business. Ball said he has personally sat down with FDA officials to explain that he intends to ramp up production this year even as the company continues to make improvements. Given drug shortages throughout the industry, he said he feels a need to do more. "So I feel like we have a real responsibility to take this action and ensure our customers get the products that their patients need," Ball said.
- here's the earnings report
- here's a call transcript from Seeking Alpha