Pfizer plant slapped with FDA warning letter for not learning from earlier mistakes

When Pfizer bought Hospira in a $15 billion deal in 2015, execs said they were well aware of Hospira’s history of regulatory issues but believed the sterile injectables company had gotten on top of its problems. The FDA obviously does not agree and sent CEO Ian Read a warning letter on Valentine’s Day saying so.  

The problems laid out in the scathing warning letter, posted today by the FDA, also are responsible for derailing the expected approval this month of the long-lasting generic version of Teva’s Copaxone, developed jointly by Momenta and Sandoz. The companies received a complete response letter for Glatopa two weeks ago because the problems at the McPherson, Kansas, plant which is handling the fill-finish work for the drug.

Pfizer has said it is working hard to resolve the FDA's concerns but the agency said in the warning letter Pfizer should have recognized long ago there were issues that needed addressing because the agency had cited five other Hospira plants for similar problems in four warning letters issued in 2010, 2013, 2014 and 2015.  

“These repeated failures at multiple sites demonstrate that your company’s oversight and control over the manufacture of drugs is inadequate,” the warning letter said.

Among other problems, the plant was criticized in the Feb. 14 letter for not fully investigating complaints of particulate detected in vials of its products. It noted the plant released one lot of an injected drug which had “brown agglomerates” observed during production. It also was cited for not taking proper steps to prevent contamination of products and for failing to send the FDA field alerts about complaints.

This all added up to bad news, not only for Pfizer, but for Momenta and Sandoz, which had expected approval this quarter of the 40 mg dose of Glatopa. Now, they have told investors they are hopeful it can happen yet this year. The partners already have a 20 mg version of the drug on the market but the long-lasting version is considered much more valuable. Teva sold $3.6 billion worth of Copaxone last year. 

On the flip side, it means a big boost for Teva, which has repeatedly lost its efforts in the courts to stop generics on patent challenges and protect sales of its Copaxone. Some analysts are suggesting it could now be a year or more before the Momenta and Sandoz drug, or a generic from another company, is able to get to market giving Teva a windfall.