F. Michael Ball has spent many earnings calls talking almost entirely about the quality problems at the company's plants and its long-running efforts to get past them. Wednesday he spent very little, an indication, executives said, that four years of effort and more than $375 million in investments are paying off.
Medtronic generated more Class I recalls than any of its device company rivals in 2013. The FDA assigns that status--its most serious label--when problems behind a product can cause serious injury or death.
The FDA is warning healthcare providers that there is a shortage of saline solution, as well as other IV solutions. The agency says it is working with Baxter International--which recently had to recall four lots of saline--Hospira and Braun to boost production.
Hospira's Irungattukottai plant, which was tagged with an FDA warning letter in May, came up short of expectations during a recent follow-up inspection.
Hospira is getting on top of its manufacturing issues in the U.S. But the company continues to face issues at a plant in India that received a warning letter in the spring. The FDA recently came back for a follow-up which turned up nearly two dozen observations.
Generic drugmakers have been expanding production in low-cost countries to drive down costs in a highly competive market. Hospira has been slow to do that. Its focus in recent years has been plant remediation in the U.S. because key facilities were not meeting FDA standards. But CEO F. Michael Ball says that will change.
Robert Wessman, the Icelandic entrepreneur who built Actavis into a generics powerhouse and then sold out, has decided get into the biosimilars business. He has talked his home country into helping finance his plans.
Hospira and its biosimilar partner Celltrion won European approval for the first biosimilar of a monoclonal antibody therapy in September when t he EU signed off on their Inflectra, a biosimilar of Johnson & Johnson's Remicade. But despite the achievement, the partners still face a huge challenge: getting doctors to use the drug.
Hospira's long-troubled infusion pump business is dealing with another recall, earning the FDA's most severe warning over a device malfunction the agency said can lead to serious injury and death.
When Hospira CEO F. Michael Ball discussed efforts to fix manufacturing quality failings in 2012, he warned the remediation project was likely to uncover a few "gators." In the end, Hospira found itself with a whole new swamp--on the device side of the business--but now believes it is nearing the end of its pharma fixes.