Former top FDA officials accuse Biden admin of ‘sidelining’ experts

President Biden touts his infrastructure bill
Associated Press

Two former Food and Drug Administration (FDA) officials criticized the Biden administration’s decision to not convene outside expert panels before authorizing COVID-19 booster shots for adults and older teens 

In a piece published in The Washington Post, Philip Krause, former FDA deputy director for vaccines research and review, and Luciana Borio, former chief scientist at the agency, wrote that authorizing vaccines without consulting with independent expert panels harmed the credibility of federal health agencies.

In the past month, the FDA has authorized booster shots for anyone over 16 years old. The Centers for Disease Control and Prevention (CDC) also revised its guidance to recommend booster shots for everyone over 18.

An FDA panel had previously raised concerns about the risk of myocarditis and pericarditis — inflammation of the heart muscle and surrounding tissue — associated with the Pfizer-BioNTech vaccine.

Last week, when the FDA announced the authorization of booster shots for 16- and 17-year-olds, the agency said the benefits offered by a single-dose booster shot outweighed the risks of myocarditis and pericarditis in older teens.

However, Krause and Borio argued that “much is lost when decisions like these are made without consulting outside experts — whatever one believes about the merits of the policies in question.”

“At this point in the pandemic, the world faces a host of new questions related to vaccines and boosting. The recommendations of experts on the outside advisory committees are needed more than ever — so the scientific community can understand the empirical bases for decisions, and so the public can be assured that science, not politics, is driving vaccine policy,” wrote the former officials.

In recent months, critics have accused the Biden administration and the Democratic Party of equating their policies directly with science, blurring the lines between policy decisions and scientifically backed recommendations.

GOP lawmakers have accused Biden’s chief medical advisor Anthony Fauci of distorting scientific information to benefit the president’s agenda, while Fauci has accused GOP figures of undermining science by attacking him. 

In their piece, the former FDA officials posited that if these policy decisions had been brought to an independent panel, some experts would have opposed the measures.

“Although some may find it convenient to make policy without their input, the long-term consequences will hurt public health,” they wrote.

Krause and Borio also pointed to the outrage that was expressed when former President Trump’s administration authorized treatments like hydroxychloroquine and convalescent plasma for the coronavirus without committee input and said the same standards should be applied to the Biden administration.

The Hill has reached out to the White House for comment.

Tags Anthony Fauci COVID-19 booster shots COVID-19 vaccination in the United States COVID-19 vaccine Donald Trump FDA Food and Drug Administration Luciana Borio The Washington Post Vaccination policy

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