It appears it will be another hard year for U.S. hospitals to get their hands on sterile injectables as work continues at Pfizer’s troubled plant in Kansas, perhaps the largest U.S. producer of the drugs.
Pfizer last year indicated things should be looking up by the second quarter of 2019, but new CEO Albert Bourla told analysts Tuesday that it will be working on issues through this year and it’ll be even longer before Pfizer will reap the benefits.
“We expect these issues to be significantly improved by the end of 2019, and we continue to expect this business to be a solid growth contributor in the future,” he said.
Pfizer has been trying to solve the problems at the troubled sterile injectables plant for nearly three years now. It acquired the facility in McPherson, Kansas, with its $15 billion buyout of Hospira in 2015. A May 2016 inspection alerted the company to problems but a 2017 warning letter made it clear the FDA was not satisfied with Pfizer’s efforts to solve those issues at that point.
Pfizer has repeatedly said its remediation efforts are progressing but as last as August of last year, the FDA pointed out it was far from meeting its standards. A 10-page Form 483 suggests from a two-week followup inspection in August exposed an operation that can’t seem to learn from its past mistakes. Of the eight observations, seven of them were repeats, some noted at least twice before. It is a failing that a frustrated FDA lamented in the warning letter to the company two years ago.
When the latest 483 was made public by the FDA last month, Pfizer again insisted it is getting on top of the problems. And in its emailed statement today Pfizer reiterated that claim, pointing out that the company has invested $800 million in its injectables operations through 2018.
“While these investments are being made, manufacturing output is reduced, creating a shortage of some important products, but we are urgently working toward increasing output at McPherson and our other facilities,” it said.
In an emailed statement on Wednesday, a Pfizer spokesman said: “We are aware of the important medications supplied by the McPherson facility and have made progress at McPherson and across our injectables network in an effort to ensure consistent supply of our medicines, which include our injectable opioids and other critical hospital injectable products.”
That said, in a private discussion with the Credit Suisse analyst team, executives acknowledged there is still a lot of work to be done if Pfizer is to recapture its standing in the generic sterile injectables arena. According to a note Wednesday from Credit Suisse analyst Vamil Divan, the company said 2019 will be a “challenging year” in sterile injectables.
Pfizer acknowledged it has been “Losing business and paying some penalties as sometimes it has to buy from competitors to honor contracts,” Divan’s note says. Right now Pfizer is prioritizing efforts where there are shortages and for those drugs where it is the only source.
While Pfizer expects 2020 to be better for its established sterile injectables business, it will have a lot of work to “win back business,” Pfizer executives acknowledged to the analysts. In shorthand, Divan said, “Over time may turn into a benefit for them as these products are hard to make,” but that positive impact will be pushed out a few years.