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# Special Counsel ‘Troubled’ by FDA Response to Whistleblower
- URL: https://www.fdaweb.com/special-counsel-troubled-by-fda-response-to-whistleblower/
- Published: 2021-04-01T12:00:00.000Z
- Updated: 2026-09-14T16:53:11.000Z
- Author: David McFarland
- Tags: Biologics, Drugs, #legacy-id-D5149019

Special Counsel **Henry Kerner** says he agrees with an assertion by former FDA consumer safety officer **Arie Menachem** that the agency narrowly focused on procedural issues in its response downplaying Menachem’s whistleblower complaints and “disregards the fact that inspection reports detailing serious concerns were downgraded in a manner that may compromise compliance and safety efforts.” Kerner’s concerns are expressed in a four-page 3/31 [letter](https://osc.gov/Documents/Public%20Files/FY21/DI-19-0931/DI-19-0931%20Letter%20to%20the%20President%5FRedacted.pdf?ref=fdaweb.com) to President **Joe Biden** transmitting the report received from FDA in response to Menachem’s allegations of improprieties in agency compliance inspections of pharmaceutical manufacturing facilities. Menachem, who resigned from FDA and is now vice president of regulatory compliance for Novo Nordisk, identified himself as the unnamed whistleblower on social media 3/31.

In a 10-page 1/3 [letter](https://osc.gov/Documents/Public%20Files/FY21/DI-19-0931/DI-19-0931%20WB%20Comments%20Redacted.pdf?ref=fdaweb.com) to Kerner, Menachem says the Office of Special Counsel (OSC) formulated questions for FDA based on his whistleblower complaint that focused on procedural issues and “unintentionally subverted the investigation from one of substance into one of procedure.” Menachem’s response addressed both the OSC questions about FDA procedure and what he calls “the agency’s gross mismanagement and implementation of policies that present a substantial and specific danger to public health and safety. The agency’s response is egregiously silent with regards to these allegations.”

Menachem’s original whistleblower complaint raised concerns about: 

- reclassification of an Official Action Indicated (OAI) report to a Voluntary Action Indicated (VAI) report from a 2017 inspection at the National Genetics Institute that determined that test results were unreliable due to the multiple systems employed that did not have provisions for data integrity;
- reclassification from OAI to VAI of a report from a 2018 inspection at Baxalta that included 12 significant inspection observations, including failure of a batch that had already been released to patients to maintain its potency throughout the product’s shelf life;
- reclassification from OAI to VAI of a report from a CSL Behring 2018 inspection that included a finding of systematic contamination of water for injection manufactured at the site with silicone oil because, according to CBER’s reclassification letter, “the observations were less than what would normally result in an OAI inspection classification”; and
- lack of sufficient inspection resources and lack of training on dealing with a confidential informant for a 2018 inspection at a Merck facility in Raleigh, NC, that resulted in inspection observations including a significant departure from data integrity and failure to perform personnel monitoring that was documented as having been performed.

In the conclusion to his response, Menachem says he was told by HHS that he could resign with no effect on his permanent record if he withdrew his OSC complaint. He says that in his letter of resignation he indicated that his conscience did not allow him to waive the complaint.

“Through gross mismanagement, FDA has broken their promise to American consumers and has allowed firms that produce biologic medical products that do not meet the requirements of the Good Manufacturing Practice to continue unfettered,’ he wrote. “It has been my hope from the beginning of filing this complaint that FDA examines its recent practices and the supervisory personnel assigned to Team Biologics to assure that the agency as a whole is capable of delivering upon its promise to the American consumer of protecting and promoting the public health. It is my sincere hope that the agency elects to do this before patients are injured (or worse) by substandard biologic medical products.”