- PharMEDium Healthcare, a subsidiary of AmerisourceBergen, will lay off more than half of the workforce at its Memphis, Tennessee compounding facility, the company said in a filing with Tennessee's Department of Labor.
- The cuts will affect 225 of the 440 employees, the parent company confirmed to BioPharma Dive in an emailed statement. The company said the manufacturing plant, which is currently suspended, will not be closing.
- In a notification to the state, AmerisourceBergen gave an effective date for the layoffs of March 12. Affected employees will be offered severance benefits and career support services, and can apply for other positions across the company.
The Food and Drug Administration has been scrutinizing drug compounders through its 2018 Compounding Policy Priorities Plan, which aims to improve quality and sterility standards and avoid a repeat of a 2012 fungal meningitis outbreak which caused 750 cases of illness and 60 deaths across 20 states.
AmerisourceBergen acquired the compounder PharMEDium in 2015 for $2.6 billion in cash. Since then, however, the facility has run into some roadblocks. The planned layoffs follow a string of Form 483s and product withdrawals by the subsidiary, resulting in regulators putting a hold on commercial operations in December 2017 with no specific date for resumption.
PharMEDium had been talking to the FDA and the Department of Justice about remediation efforts. The layoffs come as the company works to revamp the facility and sort out the concerns flagged by the FDA, many of which center around failing to have procedures that adequately protect against contamination or ensure quality control.
"PharMEDium is redeploying capital to invest in operational enhancements that will enable it to meet the sterile to sterile compounding needs of hospitals across the nation," Francesca Gunning, AmerisourceBergen's external communications manager, wrote in an email. "As these enhancements are made, PharMEDium’s Memphis facility will undergo a workforce reorganization."