A former FDA inspector accused the agency of downplaying safety problems at a Merck plant tapped to manufacture Johnson & Johnson’s COVID-19 vaccine.
The whistleblower alleged that a 2018 inspection uncovered evidence that employees in the facility in Durham, N.C. engaged in a host of unsanitary practices. A letter to President Biden from the U.S. Office of Special Counsel regarding the Merck plant accuses the company of hiding evidence of employees urinating and defecating in their uniforms rather than taking restroom breaks, which would have required them to leave the manufacturing area and change uniforms.
A Dec. 2020 Vanity Fair article echoes the assertions, describing the 2018 discovery of a “biohazard nightmare” in the Durham facility. According to a confidential informant who contacted the FDA, “feces had been found smeared on the floor of the plant’s production area.” The confidential informant also reported that employees in the facility moved freely between cleanrooms and other areas of the facility without prescribed gowning changes.
Although the FDA whistleblower identified evidence to support the confidential informant’s claims, the agency did not follow prescribed procedures for addressing such accusations. FDA also determined that only voluntary action was required at the plant, according to the letter to President Biden from U.S. Special Counsel Henry Kerner.
“FDA is committed to upholding our mandate to protect and promote public health and ensure that the products we regulate are safe and of high quality for all Americans,” said FDA spokesperson Michael Felberbaum over email. “We take this responsibility seriously and will ensure any concerns raised are reviewed and resolved appropriately.”
Merck stressed in a statement that it prioritizes “the health and safety of patients and our employees and the quality of our medicines and vaccines.”
“We produce our medicines and vaccines to the highest standards, in full compliance with regulations and good manufacturing practices,” a Merck spokesperson said. “ All of our manufacturing facilities maintain strict, well-documented safety and quality protocols that adhere to, if not exceed, current Good Manufacturing Practices (cGMPs) based on U.S. and international standards.”
To ensure compliance with CGMP standards, Merck offers comprehensive training to employees and comprehensive internal auditing. “Our vaccines undergo extensive testing prior to release by Merck and also by health authorities and their designated laboratories, in accordance with regulations,” the spokesperson added.
The letter from Kerner also expresses concern that the FDA has lapsed in its mission to protect and promote the public health. Kerner stated that the whistleblower’s account was sent to former Secretary of Health and Human Services Alex Azar who forwarded it to FDA’s Office of Regulatory Affairs.