An FDA inspector-turned-whistleblower claims the agency soft-pedaled violations at a range of pharma manufacturing plants, including a Merck & Co. vaccine facility in Durham, North Carolina, where staff allegedly destroyed evidence of unsanitary practices. Those allegations have now been passed along to the White House.
After investigating the allegations raised by a whistleblower, the Office of Special Counsel wrote President Joe Biden Wednesday to detail the claims.
While the FDA inspector raised flags about the agency's handling of violations at several plants, Special Counsel Henry Kerner told the White House he was "most concerned" about the Merck inspection and agency follow-up. The Merck plant is slated to help produce Johnson & Johnson's COVID-19 vaccine, though that work has not begun yet.
The whistleblower alleged that employees at Merck's plant were moving between cleanrooms and uncontrolled areas without properly ungowning, and that a biohazard bin contained employee uniforms soiled with blood, urine and feces. Employees were soiling their uniforms rather than taking restroom breaks, the whistleblower claimed, citing a confidential informant, because staffers would have otherwise needed to remove sterile gowning and leave manufacturing areas.
The FDA, for its part, said the investigator had failed to validate those claims. But OSC's Kerner told the White House that the whistleblower had "substantiated serious misconduct in the Merck Sharp and Dohme facility, which the agency seems to deny."
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When reached for comment, Merck didn't directly respond to the whistleblower's allegations. The company said it provides "employees with comprehensive training on all of our practices and procedures" and conducts "extensive internal auditing to ensure ongoing compliance with all requirements."
"Our vaccines undergo extensive testing prior to release by Merck and also by health authorities and their designated laboratories, in accordance with regulations," the company said.
The inspector said he was sent to inspect the 850,000-square-foot facility alone in less than a week despite multiple appeals to the FDA for more help. Inspections of similar facilities typically involve four investigators over a 21-day period, he said.
The FDA inspector "was not afforded sufficient resources to appropriately conduct this review, in a break with prior practice," Kerner wrote to Biden.
The FDA didn't follow its own procedures to follow up on the informant's allegations, either, the whistleblower claimed.
Merck's Durham plant was recently tapped in the production push for Johnson & Johnson's COVID-19 vaccine—though it's unclear when that work will start. Earlier this month, the Raleigh News & Observer reported that J&J would use Merck's Durham facility to manufacture bulk drug substance for the vaccine, with Merck's West Point, Pennsylvania, plant on deck to tackle fill-finish duties.
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It could take around two months to set up the fill-finish site, and a few months more to build out the drug substance facility, The Washington Post reported in early March, citing a person familiar with the process.
Merck told Fierce Pharma its "highest priorities are the health and safety of patients and our employees and the quality of our medicines and vaccines."
"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,” the company added.