GAO Critiques FDA Oversight of Vaccine Manufacturing

COVID-19 vaccine makers didn’t undergo pre-approval facility inspections before receiving Emergency Use Authorizations (EUAs) from the FDA for their jabs, the Government Accountability Office (GAO) says.

The GAO’s analysis, titled “COVID-19 — Additional Actions Needed to Improve Accountability and Program Effectiveness of Federal Response,” mainly focused on other HHS agencies and government departments and only dealt with the FDA’s role in two appendices.

It notes that the FDA was not required to conduct inspections prior to the emergency authorizations of the Pfizer/BioNTech, Moderna and Johnson & Johnson (J&J) vaccines, all of which occurred during the pandemic, when the agency drastically curtailed inspections.

The GAO’s assessment found that “14 of the 18 establishments that manufacture COVID-19 vaccines had been previously inspected at least once” within the past decade, comprising a total of 90 inspections. For all but one of the 14 facilities, the GAO said, the FDA’s most recent inspection occurred within the past four years.

Rather than conducting inspections, the FDA reviewed documents provided by the companies, assessed prior inspection reports, examined reports from foreign regulators and conducted on-site reviews as needed.

FDA inspections of biologics manufacturers all but stopped during the COVID-19 pandemic, GAO noted, adding that these types of inspections have been declining for several years.

The GAO noted that prepandemic, biologics facility inspections went from a “high of 1,922 in fiscal year 2013 to 1,668 in fiscal year 2019.” In the report, FDA officials attributed the lower fiscal 2019 number to lapses in agency appropriations and vacancies among the staff members conducting inspections.

And from April 2020 through March 2021, during the pause in most non- “mission-critical” inspections, the FDA conducted just 58 biologics inspections. The report explained that the agency gave higher priority to inspecting plants manufacturing COVID-19 products or drugs used to treat serious diseases during the pandemic.

None of the report’s 16 recommendations are directed at the FDA.

Read the GAO report here: www.fdanews.com/11-02-21-GAOreport.pdf. ― Jason Scott