Pfizer is being schooled in the challenges of sterile drug manufacturing that come with its $15 billion buyout of Hospira. The New York drug giant has temporarily suspended production at a plant in India that the FDA cited three years ago with a warning letter after a new visit found ongoing problems.
Pfizer ($PFE) in an email today confirmed that production was put on hold while the observations were being evaluated. It said the company has formally responded to the FDA observations.
“At the time of the inspection Pfizer temporarily paused production at the site to allow an assessment of observations by appropriate experts. A holistic plan is being developed to address specific inspection observations and to implement enhancements to site operations,” the statement said. “Patient safety is of utmost importance to Pfizer, and Pfizer is committed to ensuring the safety and quality of our medicines.
The company confirmed a report in The Economic Times that the inspection was a collaborative effort that included inspectors not only from the FDA but also from Europe’s Medicines and Healthcare products Regulatory Agency (MHRA), Health Canada and the Australian drug regulator.
In 2013, the FDA cited the plant in Irungattukottai in Chennai, India, with a warning letter that raised doubts about the company’s ability to ensure sterile drugs. It cited unsanitized surfaces, airflow questions and even the sterility of gloves worn by workers. The agency ordered Hospira to create a “global corrective action plan” for both its foreign and U.S. plants, including how it intends to train employees involved in aseptic processes.
Pfizer bought the biosims- and generics-focused Hospira for $15 billion last year to round out its generics manufacturing offerings. Just last week, it cited the unit for helping drive an analyst-beating 11% revenue jump to $13.15 billion in Q2. In fact, without the bump from Hospira, sales at its Essential Health unit would have been off 3% without currency setbacks, all but offsetting 7% growth in Pfizer’s branded side of the business.
When it struck its deal for Hospira, Pfizer execs assured investors they were well aware of the Hospira’s long and deep record of FDA concerns but believed most of the problems were behind it and everything else was manageable.
