Pfizer said several weeks ago that the FDA had updated the status of its troubled Kansas fill-finish plant, paving the way for drug approvals, and sure enough this week Novartis announced an FDA nod for its Copaxone generic being produced there. But a recently released document from the last inspection of the plant shows it continues to struggle, even repeating issues the FDA pointed out in a previous visit.
The eight-page Form 483 from the October 2017 inspection shows that of 10 observations the FDA noted, four were repeats from issues inspectors had seen in earlier visits. The FDA’s frustration over the fact that it has pointed out similar issues at a number of Pfizer's legacy Hospira plants for years is what led the agency to send Pfizer a scathing warning letter last year.
In an email today, the company said it continues to work diligently to resolve the issues: “We are pleased that the FDA has upgraded the status of our McPherson, Kansas manufacturing facility to Voluntary Action Indicated (VAI) based on an October 2017 inspection. We have a robust plan in place to bring the former Hospira sites in line with Pfizer manufacturing operations, and are diligently implementing commitments made to the FDA.”
The FDA concerns noted in the last plant visit run the gamut from insufficiently investigating customer complaints, which was a repeat, to sometimes taking weeks to report out-of-specification results for products instead of the required three days, also a repeat.
As for investigations, in one case, the FDA noted that despite receiving nearly 140 complaints about the ineffectiveness of bupivacaine HCI with dextrose, no investigation was conducted, beyond filing a trend report, to determine the cause.
The other repeated violations were for failing to visually check retained samples annually and not always documenting conclusions or investigations when reporting batch failures. The six other observations were for things like shortcomings in cleaning to prevent drug contamination and for not thoroughly training employees.
Pfizer’s inability to get on top of all the problems at the former Hospira plant has taken a heavy toll on customers and its own drug portfolio. For Sandoz and partner Momenta, it meant having their copy of Teva's long-acting Copaxone blockbuster delayed for a year by a complete response letter, allowing competitor Mylan to get its generic approved and established in the market first. Mylan’s product already has 10% of the market, which totaled $3 billion for Teva last year.
Pfizer has also lost potential sales of its own as a result of the ongoing issues. It received a complete response letter last year for its biosimilar of Amgen's blockbuster Epogen. If it hadn’t been for the manufacturing problems, Pfizer would most certainly have won approval for the biosimilar. A month before it received its complete response letter, an FDA advisory committee recommended approval in a 14-1 vote.