E&C Republicans Seek Watchdog Inquiry on FDA Laboratory Safety

Committee investigation finds FDA failing to meet safety requirements and implement GAO recommendations

Washington, D.C. - In a new letter to Department of Health and Human Services Inspector General Christi Grimm, Energy and Commerce Republicans requested an assessment of the adequacy of the U.S. Food and Drug Administration's (FDA) support for the Office of Laboratory Safety (OLS).

The letter, which comes after a long-standing investigation, is signed by 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).

KEY LETTER QUOTE:

"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."

BACKGROUND:

• In July of 2014, an incident related to the discovery of boxes containing vials of smallpox virus and other hazardous biological agents in an FDA laboratory on the National Institutes of Health (NIH) campus served to increase overall safety awareness and leadership engagement in safety programs at the FDA.
• This led to the launch of the Office of Laboratory Science and Safety (OLSS), now called the Office of Laboratory Safety (OLS), at the FDA.
• However, the FDA's course of conduct over the last few years calls into question the adequacy, appropriateness, and legality of the way FDA leadership has supported the OLS.

During the 118th Congress, the Committee conducted oversight of the FDA's laboratory safety program and identified the following concerns:

1. Regarding centralized and independent oversight of its laboratories, the FDA is not complying with Occupational Safety and Health Administration (OSHA) requirements for annual inspections nor with the spirit of OSHA regulations regarding unannounced inspections.
2. The FDA still has not fully implemented and closed out the recommendations issued four years ago from the Government Accountability Office (GAO) related to the OLS.
3. The FDA may not be sufficiently supporting its laboratory safety program with adequate funding and resources.
4. The FDA may not be providing the OLS with the authority and visibility to promote safety.

CLICK HERE to read the letter.

OUTLINE OF FDA'S SHORTCOMINGS AS STATED IN THE LETTER INCLUDE:

Frequency of Laboratory Inspections and Unannounced Inspections by OLS

OSHA has several requirements that apply to FDA oversight of laboratory safety. One of the OSHA regulations requires annual inspections of all laboratories, including sufficient unannounced inspections. The FDA's August 21, 2023, response indicates that the FDA is not meeting OSHA requirements and best practices.

In its August 21, 2023, response, the FDA stated that "[b]eginning in 2022, OLS began annual inspections of a third of the FDA laboratories on a rotating basis." In other words, the independent centralized oversight of the laboratories by OLS occurs every three years, not annually. The FDA centers conduct inspections of their own labs in the other two years. However, the FDA inspection surveys produced by the Department of Health and Human Services (HHS) show that OLS inspections make significantly more findings than the FDA center inspections. For example, the Center for Drug Evaluation and Research reported only one finding in 2020 and reported no findings in 2021. In contrast, OLS conducted an inspection in March of 2023 of a Center for Drug Evaluation and Research (CDER) facility and made 19 non-conforming findings.

However, OSHA requires annual inspections of all laboratories. According to OSHA regulation 29 CFR 1960.25(c), "[a]ll areas and operations of each workplace, including office operations, shall be inspected at least annually." The OLSS 2017-2018 Progress Report stated: "FDA is required to comply with Title 21 USC [U.S. Code] and 29 CFR 1960.25 and 1960.26 requirements for conducting annual inspections." The same report stated: "FDA committed to conducting annual audits to the House Energy and Commerce Committee and GAO to prevent incidents such as the Variola [smallpox] discovery."

The OSHA regulation further states, "Sufficient unannounced inspections and unannounced follow-up inspections should be conducted by the agency to ensure the identification and abatement of hazardous conditions."

To what extent is FDA addressing the GAO recommendations on laboratory safety?

In September of 2020, the GAO issued a report on the FDA's OLS and made five recommendations, including to resolve disagreements over roles and responsibilities, to provide OLS with the authority and access to facilities necessary to oversee laboratory safety, and to take steps to assess and mitigate any independence risks posed by how OLS is funded. HHS agreed with all five recommendations.

According to the GAO website, none of the five recommendations have been fully addressed. In a July 14, 2022, meeting with Chair Rodgers (at the time serving as Committee Republican Leader), FDA Commissioner Robert Califf committed to her that these recommendations would be closed. Our May 24, 2023, letter asked the FDA to respond specifically on the status of each of the five recommendations. The FDA's response did not directly answer our questions and failed to show that the agency has fully implemented the GAO recommendations.

Is FDA sufficiently supporting its laboratory safety program?

Information obtained through the Committee's oversight raises questions about the adequacy of FDA's funding and staffing for OLS, especially compared to those of Centers for Disease Control and Prevention (CDC) and NIH. In an August 21, 2023, letter to the Committee, the FDA reported the following about funding and staffing of OLS:

With respect to funding, the FDA has worked to reduce OLS' reliance on funding from the Centers, but receiving such funding has not hindered OLS' independence in implementing an effective safety program. OLS' total budget for the current fiscal year is $7.9 million, which includes $5.5 million in appropriations from Congress (compared to an appropriations request of $6.6 million) and additional funding from the FDA to help support preexisting staffing and programs. With respect to historical OLS funding requests and appropriations:

• In FY2019, the FDA requested $6 million for OLS. OLS received $1.5 million in appropriations from Congress. This was an increase of $1.5 million over FY2018 budget authority.

• In FY2020, the FDA requested $4 million for OLS, which is an additional $2.5 million from FY2019 appropriations. OLS received $2.5 million in FY2020 appropriations from Congress. This was an increase of $1.0 million over FY2019 budget authority.

• In FY2021, the FDA requested $2.5 million for OLS. OLS received $2.5 million in FY2021 appropriations from Congress. There was no increase from the FY2020 budget authority.

• In FY2022, the FDA requested $9.1 million for OLS, which is an additional $6.6 million from FY2021 appropriations. OLS received $4.0 million in FY2022 appropriations from Congress. This was an increase of $1.5 million over FY2021 budget authority.

OLS currently has 19 full-time equivalent employees (FTEs), as well as contract support and cross-cutting support within the Agency. These employees are dedicated to the OLS mission and work on a variety of matters, including, but not limited to occupational safety and health, environmental safety, industrial hygiene, radiation safety, and biosafety.

However, the CDC and the NIH provide more staffing and resources for more laboratory spaces, with all of them subject to annual inspection and unannounced inspections.

In a November 9, 2023, letter to the Committee, the CDC reported that the CDC Office of Laboratory Science and Safety had total funding of $23 million with 82 FTEs. CDC inspects about 2100 lab spaces annually.

In a June 2024 briefing to Committee staff, the NIH gave an estimate of $117 million supporting NIH laboratory safety activities. The breakdown includes the following service programs: Division of Occupational Health & Safety ($35.3 million), Division of Radiation Safety ($8.8 million), Division of Emergency Management ($5.7 million), the Fire Marshall ($2.9 million), Division of Fire and Rescue Services ($7.4 million), and Police ($56.7 million). The NIH reported 65 full-time equivalents (FTEs) and 100 contractors allocated for laboratory safety. All 5,000 lab spaces are inspected annually.

Is FDA providing the OLS with the authority and visibility to promote safety?

Currently, the FDA Designated Agency Safety and Health Official (DASHO) is the Director of OLS, a position at least two levels below the assistant secretary level since the Director reports to the Chief Scientist. Federal regulation 29 C.F.R. § 1960.6, published in 1980, requires that the DASHO be located at the assistant secretary or equivalent position, and have sufficient authority and responsibility to effectively represent the Commissioner in managing the FDA's laboratory safety program. Further, the regulation states that headquarters staff should report directly, or have appropriate access to the DASHO.

The current reporting structure contrasts with how the CDC prioritized this reporting relationship, and to past FDA actions and commitments. In July of 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.

In response to a question on whether the FDA would commit to having the Director of Lab Safety report directly to the Commissioner, the FDA wrote in a September 9, 2016, letter to the Committee: "To support FDA with this critical mission, FDA will realign OLSS such that the Director of OLSS will report directly to the Commissioner." The establishment of OLSS and its realignment as a direct report to the Commissioner was done through an extensive process over two administrations and formal notice in the Federal Register.

According to a June 29, 2017, memorandum from then-FDA Commissioner Scott Gottlieb to then HHS Secretary Thomas Price, in response to this recommendation and advice from an FDA work group, the FDA hired a director of laboratory science and safety in October of 2015. His memorandum stated the OLSS director initially reported to FDA's Chief Scientist, but after internal deliberation-prompted in part by an oversight letter from Congress-the FDA determined in 2016 that the OLSS director should report directly to the Commissioner. Dr. Gottlieb noted: "This realignment emphasizes [the OLSS Director's] role in centralizing laboratory science and safety activities, and better enables him to create a culture of responsibility, safety, and accountability across all FDA labs and centers. It is also consistent with sister agency organizational structures and the External Laboratory Safety Workgroup (ELSW) recommendation for direct reporting." At that time, the Director of OLSS directly reported to the FDA commissioner.

In 2018, the FDA again realigned OLSS. Without any formal notice in the Federal Register, the direct-report alignment was reversed 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 and placing it back in the Office of Chief Scientist (OCS).

In a December 10, 2018, letter from the FDA to the bipartisan committee leadership about OLS, FDA stated:

Prior to initiating this action, FDA contracted with a third-party consultant [McKinsey] to conduct a broad, high-level assessment of the Office of the Commissioner (OC). While this contract did not require submission of a final report, the consultants helped in gathering perspectives throughout the Agency. This effort resulted in a formal reorganization package subsequently submitted to HHS for approval. One of the outcomes of the assessment was to realign most of the OLSS functions under the Chief Scientist while moving certain non-laboratory related functions from OLSS to the Office of Operations.

In anticipation of the proposed changes, the Director of OLSS began conditionally reporting to the Chief Scientist in March 2018. The FDA further defended the reorganization stating:

Since then [July 2017], we have had a greater opportunity to observe and evaluate the functions of the office and have determined that laboratory safety would be best served by OCS providing day-to-day leadership [...] This decision was one of many strategic realignments proposed by FDA leadership, based in part on input from the third-party evaluator.

However, as the FDA later noted in a June 28, 2019, email to Committee staff, there was no documented justification for the realignment and renaming of OLS stating, "the requested documents [McKinsey report] pertain to the reorganization in general (and not specifically to OLS), the interview synthesis does not reference OLS at all, and there are very minimal references to OLS in the justification memos (i.e., stating that OLS will be realigned into OCS)." The FDA also did not provide any documentation to support its observation and evaluation that led the FDA to conclude in about eight months that OLSS needed to be downsized and sent back to the Office of Chief Scientist.

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