Special Counsel raises questions about FDA’s biologics inspections

Regulatory NewsRegulatory News | 31 March 2021 |  By 

In closing a whistleblower case concerning allegations of downgraded inspection findings raised by a former investigator on the US Food and Drug Administration’s (FDA) Team Biologics, US Special Counsel Henry Kerner wrote to President Joe Biden that he is “troubled” by many aspects of the case.
In the letter, Kerner says that FDA’s report on its investigation of the allegations “meets all the statutory requirements but that the findings do not appear reasonable” and urges the agency “to closely examine compliance matters like these where inspectors identified serious compliance concerns, but where the agency reclassified their findings after significant time had elapsed.”
The case involves a whistleblower who alleged in 2018 that FDA improperly downgraded inspection findings from official action indicated (OAI) to voluntary action indicated (VAI), a less serious finding, without filing associated reclassification memoranda for inspections of the National Genetics Institute, Baxalta and CSL Behring in 2017 and 2018. Details of the whistleblower case were first reported by Vanity Fair last December.
The whistleblower’s allegations involving Merck Sharpe and Dohme are the most serious and claim that the company “was intentionally destroying evidence of possible violations [and] the improper presence of a biohazard bin used to collect employee uniforms soiled with urine and feces” at its Durham, North Carolina vaccine facility. The whistleblower said that FDA did not follow proper procedures for investigating information provided by a confidential informant (CI) at the company, who sent a letter to FDA in September 2018, more than a month before the inspection, and complained that their higher-ups at FDA did not provide adequate support or time for the inspection. Merck recently received $105 million in funding through the Defense Production Act to upgrade the facility to produce bulk drug substance for Johnson & Johnson’s COVID-19 vaccine. While Kerner’s letter does not mention the location of the facility, other documents related to the case refer to the facility’s FDA establishment number.
Per Kerner’s letter:
“[The whistleblower] explained that despite multiple formal requests for additional inspection resources, he was instructed to inspect the 850,000 square foot facility by himself in under a week. He provided information indicating that the inspection of similar facilities typically involved four investigators and 21 inspectional days. Further, he explained that while the FDA was contacted by the CI via letter in September 2018, over a month before the inspection was conducted, he was not provided with the letter or aware of the CI until he had initiated his inspection in late October. He explained that once he was notified of the CI’s existence and assertions, FDA management increased the scope and complexity of the inspection without providing [redacted] with additional resources or time to complete it.”
In February 2019, Kerner wrote to then-Secretary of Health and Human Services Alex Azar, requesting an internal investigation of the allegations. In its June 2019 report on the investigation, FDA refuted the whistleblower’s allegations, asserting that it downgraded inspection findings for the National Genetics Institute, Baxalta and CSL Behring in line with its existing procedures. “During the time covered by the allegations, neither the Regulatory Procedures Manual (RPM), Chapter 4, nor other FDA policy required the issuance of an inspection reclassification memorandum when [the Office of Regulatory Affairs] ORA downgraded an inspection,” FDA wrote, adding that a memorandum was included in the administrative file for the Baxalta inspection and that the Office of Biological Products Operations (OBPO) issued a standard operating procedure requiring compliance officers to document the rationale for changing an inspection classification in December 2018. FDA also said that a reclassification memorandum was signed by the Center for Biologics Evaluation and Research (CBER) consumer safety officer in the case of CSL Behring.
In response to the allegations concerning Merck, FDA wrote that the whistleblower was unable to substantiate the information provided by the CI and said the whistleblower “was provided support from ORA management in the form of an inspection plan specifically designed by ORA management to direct Complainant on critical areas to review and evidence to collect to narrow the focus of his inspection and attempt to substantiate the CI’s complaint.”
Despite closing the case as “totally unsubstantiated,” Kerner agreed with the whistleblower’s assertion that FDA “narrowly focuses on procedural issues” in its report and “disregards the fact that the inspection reports detailing serious concerns were downgraded in a manner that may compromise compliance and safety efforts. While these downgrades appear within the authority of agency management, questions remain about their suitability.”
Kerner also disagreed with FDA’s finding that the whistleblower was unable to corroborate allegations made by the CI regarding Merck: “Most concerningly, [the whistleblower] provided information indicating that the FDA’s assertions regarding his inability to corroborate the CI’s allegations were not true. In fact, [the whistleblower] substantiated the presence of a biohazard bin where uniforms soiled with urine, feces, and blood were disposed of. He also determined that personnel were moving between cleanrooms and uncontrolled areas without properly ungowning. Further, there was an absence of required environmental monitoring documentation in firm records.”


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Tags: FDA, inspections, US

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