The FDA’s Johnson & Johnson-Vaccine Pause Should Outrage Congress

S enator 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.

Because the FDA hasn’t officially rescinded its emergency-use authorization for the Johnson & Johnson vaccine, there is not much of practical consequence that Congress can do to mitigate the damage today’s announcement has done. The primary problem in this case is of perception: At precisely the moment that the federal government is trying to convince skeptics to get vaccinated, the FDA has provoked headlines that will have the opposite effect. But it would behoove Schatz and his 99 colleagues in the Senate to think more deeply about whether it is a good idea for our agencies to have so much power — and, indeed, to ask whether the American system of government anticipates that lawmakers will outsource as many intrinsically political decisions as they currently do. Little by little, year by year, we have allowed our representatives to create a constitutional order in which the primary function of federal legislators is to urge the president and the agencies that he runs to take action of which they approve. What happened this morning was the natural product of that system.

The most convincing argument in favor of the existence of agencies such as the FDA is that, unlike the laymen in Congress and the White House, their staff have the time, equipment, and expertise to study the sorts of intensely complex questions that our intensely complex world routinely throws up. But, even if one accepts this argument in toto, one is still obliged to draw a distinction between the collection and examination of useful information and the political and moral decisions that are made on its back. Today, the FDA conflated the two. It did not merely assemble an imperative set of facts — that out of the nearly 7 million people who have taken the Johnson & Johnson vaccine, six have developed blood clots — it made a judgment about the appropriate response to those facts that should by rights be reserved to our elected officials. Discovering the objective statistical risk of using the Johnson & Johnson vaccine is a scientific endeavor. Applying that data to the real world is not. By recommending that use of the Johnson & Johnson vaccine be paused, the FDA rendered a value judgment. Congress and President Biden should be outraged at this usurpation of their power.

Americans who make this case are often accused of being hostile toward experts or dismissive of science. Such accusations are false. There is, of course, an important place for specialists in our debates over medical strategy, just as there is an important place for the army in our debates over foreign policy. But if, in the middle of a campaign, the leader of a given branch of the military put out an independent statement recommending that hostilities be paused pending “further review,” we would rightly recognize that step as an overreach that undermined civilian control and spread doubt among those involved. The job of our military brass is to provide specialized information to the White House so that the commander-in-chief can make the tough decisions that result. The FDA must be obliged to play the same role: To be listened to, but not to dictate; to observe and collate, but not to pronounce; and to remember at all times that it exists at the sufferance of the people we hire to make the hard calls.