Pfizer has spent years on the receiving end of the FDA's wrath for continued manufacturing issues surrounding the drugmaker's 2015 buyout of Hospira. Now, after a year of trying to right the ship with that portfolio, Pfizer may have found its footing, with supply on the upswing.
Pfizer may have turned the page on long-standing issues with its sterile injectables supply after remediation and modernized manufacturing investments have allowed the company to stock 90% of its portfolio, CEO Albert Bourla told analysts on a first-quarter earnings call Tuesday.
In March, Pfizer distributed seven-and-a-half times the baseline demand of 30 of its sterile injectable products to cover back demand, including the shipping of 10 drugs at more than double the demand, Bourla said. In certain cases, Pfizer delivered sterile injectables at more than five times demand, showing the drugmaker's newfound ability to ship its portfolio at scale.
In all, Pfizer's sterile injectables portfolio grew 15% in the first quarter from the same time period the previous year.
If Pfizer's sterile injectables issues have finally eased, it would mark the success of a multiyear effort to bring the portfolio into compliance after a series of setbacks at the drugmaker's facility in McPherson, Kansas.
In January 2019, Bourla predicted that Pfizer would begin righting the ship with its sterile injectables in 2020 after years of manufacturing issues.
Pfizer acquired the McPherson facility after a $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 the FDA found the plant was far from meeting federal standards in an August 2018 inspection. A 10-page Form 483 at the time exposed an operation that couldn'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.
Those most recent mistakes came after Pfizer said it had invested $800 million in its injectables operations through 2018.
But the McPherson facility is only the most egregious example of Pfizer's sterile injectables flaws.
Earlier this month, the FDA posted a warning letter that thrashed the company’s Vizag, India, sterile injectables plant for three issues that questioned the plant’s methods for ensuring the sterility of the injectable drugs, including an issue that it had been noted in a 2018 inspection. The letter followed an inspection of the plant last fall.
Pfizer last year closed two India plants with a combined 1,700 workers picked up in the Hospira buyout. The U.S. pharma shut down the long-troubled injectables facility in Irungattukottai, India, as well as another site in Aurangabad, India. The closures were due to a fall in demand for the products the plants produced and unrelated to the FDA issues, Pfizer said at the time.