Sterile injectable drug maker Hospira last year ramped up production of the sedative and analgesic propofol, a drug CEO F. Michael Ball said he knew the market was anxious to see a bigger supply of. But the drugmaker is now recalling 7 lots of the drug because glass and metal particles have been found in some vial samples.
Hospira is one step closer to selling a Herceptin biosimilar in Britain. The U.S.-based drugmaker persuaded a U.K. court to overturn two Roche patents on the drug. And that means, as of now, Herceptin (trastuzumab) could be open to biosim competition when its main patent expires July 28.
Costs mount quickly when manufacturing issues are bad enough to attract the FDA's attention. There can be a substantial hit to value if investors get freaked out, and sometimes that can lead to litigation that makes the proposition even more expensive. That is what happened to Hospira, which has agreed to pay $60 million to settle an investor lawsuit.
Hospira is getting past quality issues that for several years dominated its attention and undermined its revenues. Now it has unburdened itself of litigation that came along with it.
Hospira CEO F. Michael Ball last year came out $1.1 million ahead, with $9.89 million in total compensation, compared with $8.78 million in 2012.
Hospira's board has stuck with F. Michael Ball as he has steered the company through a tough regulatory patch in which it had to invest hundreds of millions of dollars to upgrade its plants. For his efforts, Ball last year came out further ahead than in 2012, although not nearly as well as the year he was hired.
The FDA is slamming Hospira again over more problems at its Rocky Mount, NC, manufacturing facility. The maker of infusion pumps, injectors and other related medical devices disclosed it faces yet another warning letter from regulators based on more quality system violations.
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.