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Thursday, September 21, 2023

Experts Identify Safeguards to Help Health Agencies Protect Against Potential Political Interference

There were allegations that FDA was pressured to issue an emergency use authorization for hydroxychloroquine and chloroquine to treat COVID-19.

Recent reports have identified shortcomings in the Department of Health and Human Services’ (HHS) response to the COVID-19 pandemic, including allegations of political interference. 

Experts participating in a roundtable convened by the Government Accountability Office (GAO) have identified safeguards that could help HHS agencies protect against potential political interference. The safeguards cover documenting decisions, greater transparency, and establishing scientific integrity processes.

HHS agencies—including the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the National Institutes of Health, and the Administration for Strategic Preparedness and Response —have been at the forefront of the federal government’s response to the COVID-19 pandemic. Like most federal agencies, HHS leadership consists of both political appointees and career officials who work together to oversee agency operations and implement the administration’s policy priorities. Political involvement or undue external influence becomes interference when it seeks to undermine an agency’s impartiality, nonpartisanship, and professional judgment, according to the National Academies of Sciences, Engineering, and Medicine.

Since the beginning of the COVID-19 pandemic response, there have been allegations of political interference at the HHS agencies in GAO’s review. For example, there were allegations that FDA was pressured to issue an emergency use authorization (EUA) for hydroxychloroquine and chloroquine to treat COVID-19. In March 2020, the President stated that trials of these drugs to treat COVID-19 were producing encouraging results and would be available to Americans almost immediately. About a week later, the Biomedical Advanced Research and Development Authority sponsored an EUA request to use these drugs to treat COVID-19. FDA issued an EUA two days later. Some stakeholders—including several former FDA officials—expressed concern regarding FDA’s EUA, stating that data regarding the safety and effectiveness of these drugs for the treatment of COVID-19 were largely anecdotal at the time the EUA was issued. The EUA was later revoked after data from a large randomized controlled trial showed no evidence of benefit for mortality or other outcomes. In addition, other allegations stated that the White House pressured the CDC Director to adopt different recommendations than CDC’s advisory committee when the administration announced its plan to make COVID-19 vaccine booster shots available prior to FDA and CDC review. In September 2021, news articles discussed concerns of health experts and scientists over the role that politics may have played in the administration’s decisions regarding booster shots. Members of CDC’s advisory committee expressed concerns that the data did not necessarily support a booster for the general population. Other allegations include those related to mask guidance. A member of Congress wrote a letter to the Secretary of HHS expressing concerns about political interference related to its constantly changing mask guidance and asked for additional information on who was involved in the decisions.

GAO has found that selected HHS agencies have taken, or are in the process of taking, steps related to some of the safeguards identified during the roundtable. For example, HHS officials told GAO that the department is updating its existing scientific integrity policy, as required by a presidential memorandum issued in January 2021. According to officials, the updated HHS policy will include specific provisions prohibiting political interference and clear procedures for reporting and handling allegations of political interference, among other things. In another example, HHS has designated an interim scientific integrity official dedicated to ensuring scientific integrity at HHS.

The roundtable follows GAO’s April 2022 report which recommended that procedures for reporting and addressing potential political interference in scientific decision-making are developed and documented, including adding a definition of political interference.

While establishing safeguards against potential political interference is important, the roundtable experts noted that no agency is fully insulated from political influence and there is an appropriate role for political appointees and elected officials in agency processes. For example, experts told GAO it is appropriate for a political appointee or elected official to encourage an agency to expedite or prioritize a project. However, experts said it would be inappropriate to exert influence in a manner that interferes with the scientific integrity of the process or seeks to distort or misuse the science behind a decision.

Read the full report at GAO

Kylie Bielby
Kylie Bielby has more than 20 years' experience in reporting and editing a wide range of security topics, covering geopolitical and policy analysis to international and country-specific trends and events. Before joining GTSC's Homeland Security Today staff, she was an editor and contributor for Jane's, and a columnist and managing editor for security and counter-terror publications.

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