The Chairs’ request comes amid ongoing investigation into

federal lab safety practices

Washington, D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Subcommittee on Health Chair Brett Guthrie (R-KY), and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA), on behalf of the Health and Oversight Subcommittee Republicans, today wrote to Food and Drug Administration Commissioner Robert Califf.

The letter follows up on the FDA’s responses to the Chairs' May 24, 2023, letter and outlines concerns with how the agency has treated laboratory safety through its: 

• Lack of support for lab safety demonstrated by weakening the Office of Lab Safety and removing science from its mission  
• Noncompliance with key Occupational Safety and Health Administration (OSHA) regulations 
• Failure to fully address five key recommendations from the Government Accountability Office (GAO)

CLICK HERE to read the full letter. 

KEY EXCERPT: 

“We are deeply concerned that the FDA is not meeting important federal safety requirements to protect its employees and the public while also failing to prioritize scientific data quality delivered from FDA laboratories. Finally, the response also did not address several critical questions raised in our letter. Accordingly, we are following up to outline our concerns and to submit targeted document requests that are responsive to the Committee’s oversight.”

BACKGROUND ON RENAMING AND RESTRUCTURING OF OLS:

• Currently, the Director of OLS does not directly report to the Commissioner.  
• This is contrary to how the CDC prioritized this reporting relationship and to past FDA actions and commitments. 
• In July 2015, the External Laboratory Safety Working Group (ELSW) for laboratory safety improvements at the FDA included a recommendation that the FDA make leadership changes, including hiring a Director of Laboratory Science and Safety with a direct reporting line to the Commissioner. 
• According to a June 29, 2017, memorandum from then-FDA Commissioner Scott Gottlieb the FDA hired a director of laboratory science and safety in October 2015. 
• The FDA determined in 2016 that the OLSS director should report directly to the Commissioner. 
• In 2018, the FDA again realigned OLSS without any formal notice in the Federal Register during a 2018 Office of Commissioner reorganization. 
• This reversal was purportedly based on a McKinsey consulting report, but the FDA would not produce to the Committee any documentation from the McKinsey report to support the realignment of the OLSS office. 
• The FDA in 2018 reorganized OLSS and removed laboratory science from its portfolio while putting the laboratory safety office without the science portfolio in the Office of Chief Scientist.  
• The OLSS was renamed the Office of Laboratory Safety (OLS). 
• The FDA’s scoping and alignment of its laboratory office diverges from the actions of its sister agency at the Department of Health and Human Services (HHS), the Centers for Disease Control and Prevention (CDC). 

BACKGROUND ON NONCOMPLIANCE WITH OSHA REGULATIONS:

• OSHA has several requirements that apply to FDA oversight of laboratory safety. 
• One regulation requires annual inspections of all laboratories, including a sufficient number of unannounced inspections. 
• The FDA’s responses to the Committee’s ongoing investigations indicate that the FDA is not meeting OSHA requirements and best practices. 

BACKGROUND ON FDA’S FAILURE TO ADDRESS GAO LAB SAFETY RECOMMENDATIONS:

• In September 2020, the GAO issued a report on the FDA’s OLS and made five recommendations to provide OLS with the authority and access to facilities necessary to oversee laboratory safety. 
• The Department of Health and Human Services agreed with all five recommendations. 
• According to the GAO website, none of the five recommendations have been fully addressed. 

ADDITIONAL BACKGROUND:

• The Committee began this Congress with an Oversight and Investigations Subcommittee hearing titled “Challenges and Opportunities to Investigating the Origins of Pandemics and Other Biological Events” that focused in part on federal biosafety practices. 
• The Subcommittee then held an April 27, 2023, hearing titled “Biosafety and Risky Research: Examining if Science is Outpacing Policy and Safety” 
• Committee Republicans sent a letter to the FDA on May 24, 2023, outlining concerns with the agency’s lab safety policies.