More than a year after spending roughly $17 billion to acquire Hospira, Pfizer is finding that curing the manufacturing woes at the company is not going to be easy. The big drug maker recently halted production at a plant near Chennai, India, after inspectors from several regulatory agencies, including the US Food and Drug Administration, found various quality control problems.
During an inspection last June, the agencies decided that the facility, which makes injectable drugs, deviated from good manufacturing practices, a standard benchmark for safe production. A Pfizer spokeswoman wrote that no safety issues were reported with any medicines distributed from the site and that a “holistic plan” is being developed. But she did not offer a timetable for resuming production.
“At the time of the inspection, Pfizer temporarily paused production at the site to allow an assessment of observations by appropriate experts,” she explained. “Pfizer has not identified any issue that has an impact on marketed products … The site is fully engaged and is working toward resuming production as soon as possible.” The infractions were first reported by The Economic Times.
The problems at the facility are only the latest to plague Pfizer’s Hospira unit, which sells a variety of injectable and infused drugs. Over the past several years, numerous Hospira plants — in the United States, Europe, Asia, and Australia — have experienced various production gaffes and, subsequently, issued dozens of product recalls. The same facility in Chennai received an FDA warning letter in 2013.
At times, the problems were embarrassing. In early 2014, Hospira executives were confident that the issues were starting to recede. So a Hospira executive told analysts in a conference call that after FDA officials upgraded the status of a key plant, “I think we’ve got the swamp drained” of alligators. A few months later, though, the gators appeared elsewhere as yet another plant ran afoul of regulators.
The long-running problems cast a pall over the company, although not enough to dissuade Pfizer. This is because Hospira has been one of the largest purveyors of generic injectable medicines, which can help further Pfizer’s ambitions to become a player not only in the expansive hospital market, but also in biosimilars, which Hospira had already been selling in Europe.
The latest infractions, however, should not suggest that the Hospira unit is rife with systemic quality-control problems. But the fact that regulators from four agencies — besides the FDA, the UK’s Medicines and Healthcare products Regulatory Agency, the Therapeutic Goods Administration of Australia, and Health Canada — took part in the inspection indicates a notable level of concern.
One expert said the extent of the problem is difficult to ascertain since inspection reports do not appear to be available on the agencies’ web sites. “It really depends on whether the same issues are raised during this inspection (as in 2013), or whether there are other material observations,” said Vince Suneja of the Suneja Law Group, an attorney who advises drug makers on international markets, particularly India.
“If they are the same observations, then they will have to look at additional training and seeing if further modifications need to be made to the facility,” he said.
Of course, if new problems were discovered, more than modifications may be required.