A former Food and Drug Administration safety officer has alleged the agency did not follow procedure when supervising a Merck factory being modified to help produce Johnson & Johnson’s coronavirus vaccine, Politico reported.
In a complaint filed by the Office of Special Counsel, Arie Menachem accused inspectors of not following established procedure in a 2017 inspection in which they downgraded the Merck facility in Durham, N.C., from a rating requiring immediate corrective action to a less-urgent category.
Menachem said inspectors did that despite serious hygiene and public health concerns he later discovered.
The publicly released version of the complaint did not name Menachem or the Merck location, but the former safety officer confirmed his identity and the site of the plant to Politico.
The FDA, Merck, and Johnson & Johnson had not responded to requests for comment.
During a 2018 inspection, Menachem allegedly found that Merck improperly disposed of biohazard bins used to collect employees’ waste, and said employees were “soiling their uniforms rather than taking bathroom breaks which would have required them to disrobe and leave manufacturing areas,” according to the complaint.
The complaint also said Menachem accused Merck of “intentionally destroying evidence” of those violations.
Menachem told Politico he had raised concerns about four different drugmakers’ facilities, but Merck’s Durham plant was “the straw that broke the camel’s back.”
The reclassification meant the facility “didn’t have to do anything” to address safety and hygiene concerns, Menachem said.
Due to the reclassification, the Durham plant was exempt from further scrutiny. The more serious category, “Official Action Indicated,” would have required Merck to prove it had addressed the FDA’s concerns or face warning letters and even restricted manufacturing.
The FDA instead shifted the plant to a lesser category, “Voluntary Action Indicated,” suggesting changes were not urgently needed.
The Durham factory might not have been high on inspectors’ lists for new evaluations after the agency downgraded it after the 2018 inspection.
Concerns about the safety of inspectors and the difficulty of travel during the pandemic have caused FDA inspections of manufacturing facilities to decrease. The agency recently began resuming critical inspections.
Menachem also suggested that FDA’s inspection team was understaffed. He described being ordered to inspect the 850,000-square-foot facility by himself in less than a week – a job usually spread out among four inspectors during a 21-day period.
“I am troubled by many aspects of this matter,” Special Counsel Henry Kerner wrote in a letter to President Joe Biden, adding that he concurs with Menachem that the agency “narrowly focuses on procedural issues, and in so doing, disregards the fact that inspection reports detailing serious concerns were downgraded in a manner that may compromise compliance and safety efforts.”
Kerner also sent copies of the letter to the chairs and ranking members of the Senate Health, Education, Labor and Pensions, and House Energy and Commerce committees, which could conduct their own investigations.
In early March, Merck announced it would help Johnson & Johnson bottle millions of vaccine doses starting as soon as May, and begin producing vaccine substance itself by the second half of the year.
Johnson & Johnson vaccine substance is slated to be produced at the Durham plant. A Merck facility in Pennsylvania will bottle J&J doses.
Report of the complaint came as Johnson & Johnson tried to ramp up vaccine production after barely meeting its goal of delivering 20 million doses by the end of March.
Source: Newmax
