A number of AbbVie products coming out of its North Chicago, Illinois, manufacturing facility have been tied to death complaints, including its mammoth blockbuster Humira, and the FDA says the drugmaker has not done enough to investigate those complaints.
During an inspection at the plant late last year, FDA inspectors found that AbbVie had received five complaints tied to deaths after taking Humira and Venclexta. While the drugmaker reported those, it didn’t go back and compile historical data about death complaints tied to drugs coming from the same lots. It turns out those lots had been tied to another 8 to 11 complaints each, the FDA noted in a Form 483 seen by STAT.
In a statement shared with FiercePharma, an AbbVie spokeswoman countered the FDA observation, saying the company “investigates all complaints where a death has occurred during the use of our products,” and that “written complaint procedures are in place to investigate, analyze and resolve complaints.” As for the observations at hand, she said AbbVie has responded “satisfactorily.”
Humira, with worldwide sales of $18.4 billion in 2017, accounted for about 65% of AbbVie’s total revenues that year. As for Venclexta, the FDA just allowed it to be used in combination with Rituxan as a second-line therapy for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma, regardless of 17p deletion.
The FDA also found AbbVie’s procedures for handling death complaints for products made at the plant “inadequate.” For example, for Lupron, a product for prostate cancer and endometriosis, among others, no document showed that AbbVie evaluated complaints to see if there were other ones for nearby lot numbers or different strengths, or that it examined the reserve sample.
Moreover, the agency also warned AbbVie for not examining reserve samples at least once a year for evidence of deterioration, and for its failure to investigate drug batches manufactured close to a problematic one.
Last September, Pfizer’s Meridian Medical Technologies plant near St. Louis, Missouri, which makes EpiPen for Mylan, was dinged by an FDA warning letter for failing to thoroughly investigate hundreds of complaints about EpiPen failures during emergencies, some cases in which patients subsequently died. Around the time the agency was carrying out a reinspection of the plant that led to the warning letter, Mylan was recalling about 80,000 Pfizer-made epinephrine autoinjectors.
Another Pfizer fill-finish plant in Kansas was recently cited by a Form 483 with 10 observations, four of which were repeats of problems the FDA had previously observed, including insufficient examination of customer complaints to determine the cause.