FDA guidance issued on June 19 outlines steps that drug manufacturers should take to minimize the risk of COVID-19 infection among employees and contamination of the drug supply. The guidance says that employees who test positive for the SARS-CoV-2 virus, which causes COVID-19, should be excluded from drug manufacturing areas and not return to work until they’ve met the criteria of the Centers for Disease Control and Prevention (CDC) to discontinue home isolation, which includes a period of symptom-free days or consecutive negative test results.
If a worker has been exposed to the virus, the manufacturers should instruct the employee to work from home or elsewhere, according to the guidance. If an employee is infected, the facility should clean and sanitize the area and implement more frequent cleaning and sanitizing procedures as well as increased use of personal protective equipment.
Exposed employees deemed essential should follow the CDC’s guidance for essential workers, which says they may be permitted to continue to work “provided they remain asymptomatic and additional precautions are implemented to protect them and the community.”
The FDA’s guidance says that strict implementation of existing microbiological controls “may be sufficient to protect the drugs and materials.” But, for certain drug products more susceptible to contamination, the agency recommends that companies perform a risk assessment focused on SARS-CoV-2.
For example, manufacturers may want to consider whether the cell lines being produced or used could replicate SARS-CoV-2 or whether cell banks and harvest testing for viruses include SARS-CoV-2. The agency suggests that companies examine whether adequate controls are in place for procedures that occur in open systems, such as buffer and media preparation areas.
The FDA said that it is not aware of any drugs that have been contaminated with SARS-CoV-2, but that if a drug supply is suspected of contamination, it should not be released and must be quarantined for reevaluation.
The FDA’s guidance addresses some of the issues highlighted by PwC partners in March regarding maintaining employee and site safety as the pandemic hit the US. However, questions remain.
The agency has continued to postpone its domestic and foreign manufacturing inspections, making it unclear how it will be able to ensure that drugmakers are taking the necessary precautions.
Some manufacturers have posted updates online about their policies and procedures to keep employees and their facilities safe, including temperature checks, split work schedules and additional cleaning (see here and here). But cases in some regions of the US are increasing, which could put some facilities at greater risk.
HRI’s analysis of the top 16 states by number of manufacturing facilities found that six are experiencing an uptick in cases as tracked by the Johns Hopkins University of Medicine coronavirus dashboard. California, which has the most manufacturing facilities at over 140, has reported about 3,000 cases per day since early June, up from fewer than 2,000 per day in April and May.
Texas, which has the third-highest number of facilities, has had a steep increase in COVID-19 cases over the past few weeks. Meanwhile, cases are decreasing in states such as New Jersey, New York and Pennsylvania, which are among the top 10 states in terms of drug manufacturing sites.