FDA Johnson & Johnson COVID Vaccine Pause: Congress, President Biden Should Be Outraged

Senator Brian Schatz of Hawaii disagrees with the Food and Drug Administration, which this morning recommended that distribution of the Johnson & Johnson coronavirus vaccine be paused pending “further review.” On Twitter today, Schatz confirmed that he respects “the independence of the FDA and their need to evaluate risk,” but proposed that “6 [cases of life-threatening blood clots] out of 6.8 million [vaccine recipients] is not a lot, and if they are going to land on ‘we reviewed the data and everything is fine,’ they need to be clear and quick and unequivocal.”

Schatz is correct to be displeased by what the FDA has done today, which in theory is to issue a recommendation but in practice is to set back the immunization effort beyond measure, but he is disastrously incorrect when he casts the FDA as an “independent” agency whose role it is to “evaluate risk.” The FDA is an executive agency that was created by Congress, that is bound by federal statute, and that operates under the superintendence of the president of the United States. It is not “independent” or “self-sufficient” or a de facto “fourth branch” of government; it is a creation of, and is controlled by, our elected officials. Those officials, of which Schatz is one, should involve themselves more readily in its supervision.

About the Author

Charles C. W. Cooke

Charles C. W. Cooke is a senior editor at National Review and the host of The Charles C. W. Cooke Podcast.

Featured Tags

Senator Brian Schatz of Hawaii disagrees with the Food and Drug Administration, which this morning recommended that distribution of the Johnson & Johnson coronavirus vaccine be paused pending “further review.” On Twitter today, Schatz confirmed that he respects “the independence of the FDA and their need to evaluate risk,” but proposed that “6 [cases of life-threatening blood clots] out of 6.8 million [vaccine recipients] is not a lot, and if they are going to land on ‘we reviewed the data and everything is fine,’ they need to be clear and quick and unequivocal.”

Schatz is correct to be displeased by what the FDA has done today, which in theory is to issue a recommendation but in practice is to set back the immunization effort beyond measure, but he is disastrously incorrect when he casts the FDA as an “independent” agency whose role it is to “evaluate risk.” The FDA is an executive agency that was created by Congress, that is bound by federal statute, and that operates under the superintendence of the president of the United States. It is not “independent” or “self-sufficient” or a de facto “fourth branch” of government; it is a creation of, and is controlled by, our elected officials. Those officials, of which Schatz is one, should involve themselves more readily in its supervision.