Past FDA whistleblower disclosures raise safety questions concerning COVID-19 vaccine trials and manufacturing

by Nick Younger, Communications Associate

Published on December 15, 2020

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Past FDA whistleblower disclosures raise safety questions concerning COVID-19 vaccine trials and manufacturing

Multiple Covid-19 vaccines are rapidly nearing market release in the United States following several pharmaceutical companies receiving public funds through Operation Warp Speed. However, the close public scrutiny of these vaccines have highlighted the opportunities for fraud and malfeasance. With oversight of the production of these vaccines falling to the federal Food and Drug Administration (FDA), the whistleblower complaints levied at the FDA and several vaccine-manufacturing companies in recent years have become more concerning.

Interviews with whistleblowers and other insiders in the FDA and vaccine plants from a December 2020 article written by Vanity Fair present troubling accounts of mismanagement, lax inspections, and attempts to conceal legitimate issues in vaccine production.

Arie Menachem, a former FDA consumer safety officer turned whistleblower, witnessed clear violations of FDA safety protocols at drug maker Merck’s Durham, North Carolina-based vaccine-manufacturing plant in 2018 wherein Merck denied any problems. Receiving additional documents from a whistleblower inside the plant that described unsanitary and unsterile work conditions, Menachem asked his supervisors for help in the investigation into the whistleblower’s allegations. However, the FDA denied his request for additional investigators to join him.

In November 2018, Menachem filed a whistleblower complaint with the U.S. Office of Special Counsel, claiming the FDA failed to properly regulate these manufacturing plants. After his inspections at the Merck plant, as well as three other manufacturing plants, Menachem alleged that his supervisor and other FDA compliance officers downgraded his findings, allowing the facilities to avoid regulatory enforcement. Six months later, Menachem resigned from the FDA after facing numerous retaliatory actions, including being put under investigation for living part-time in Israel, a pre-approved arrangement with his supervisor.

In looking deeper at the FDA, the team Menachem was a part of, Team Biologics, documented concerns and observations at 86% of inspections from 2015 to 2019, yet no warning letters were ever issued. According to July 2019 analysis by Science magazine, the FDA’s issuance of warning letters dropped by one third under President Trump. FDA warnings and observations typically are made public to help keep companies honest, says former FDA regulator Steven Lynn, that has not been the case as of late.

As Covid-19 vaccine candidates developed under Operation Warp Speed await approval, millions of doses have already been manufactured, Vanity Fair says. With funds pouring into companies manufacturing vaccines and pressure mounting on the FDA and the government to approve vaccines, the opportunity for fraud only increases. Menachem’s reports of the FDA downgrading inspection results for unsafe manufacturing facilities, superfluous investigations, and threats of termination paint a troubling picture as the FDA begins to oversee and clear COVID-19 vaccines for use.

Pairing this lack of transparency with accounts of retaliation at the FDA like that which Menachem experienced, it is clear that strong whistleblower protections and incentives will be greatly needed in order to ensure vaccine safety. Whistleblowers should be encouraged to come forward in order to root out fraud, waste and abuse. Transparency will be critical for the safe development of COVID-19 vaccines, and whistleblowers can help guarantee it.

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