This is completely hypothetical so let’s keep it in GQ territory. Mods you may want to move this to The Quarantine Zone.
In the US, which federal department has responsibility for approving a human vaccine? I think it’s the FDA, and if it is, would the head of the FDA have the final say on a vaccine’s approval?
What role would the CDC have in that decision, if any? Would they be advisory?
Can a president override a decision/rule made by the FDA through an executive order?
Since the head of the FDA serves at the pleasure of the president, if the president disagrees with him or her, and can’t persuade them to change their mind, the president can fire that person and appoint an acting head of the FDA to do his bidding until the Senate approves a replacement. But wouldn’t an EO be easier?
Help fight my ignorance. I slept through most of my 8th-grade first-period government class that started at 7:30 AM.
I would be both surprised and dismayed if any individual has the authority to approve or disapprove a vaccine or any other medicine. I would expect that there’s an objective list of criteria that a medicine must meet in order to be approved, and any given medicine either meets those criteria or it doesn’t. The administration of the CDC or FDA might alter those criteria, but not on a case-by-case basis.
Does the FDA’s Expanded Access regime figure in to any of this? (I really do not know.)
(Expanded access allow "…a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. ")
Look up the history of Frances Kelsey, who was the one individual at the FDA who blocked the approval of Thalidomide in the USA. This despite its approval in Canada & most of Europe, and despite a lot of political pressure brought against her by the manufacturer & their lobbyists. A real heroine.
If one strong-willed person like that can block a drug, presumably there is also one person who could approve it.
I don’t think that follows. It’s far more likely that one person can stop something than that one person can push something through over the objections of others.
Even though they are part of the Executive branch and the president is their ultimate boss congress can and does pass laws that tell these agencies how they can run and make certain rules.
The president can not override those with an executive order.
That said, I have no idea what laws exist, if any, as regards this. Just something to consider.
Expanded access wouldn’t be relevant for a vaccine. EA is for people with a life-threatening disease. Vaccines are for people who don’t yet have a disease.
My reading of the Public Health Service Act is that the Director of the FDA is the one who approves a vaccine. Since the director of the FDA serves at the discretion of the president, a Director could be fired for not approving a vaccine and replaced by a more pliant official.
The FDA approves vaccines, based on a process similar but not identical to that for drugs. I am unaware of the FDA commissioner having the responsibility of signing off on every drug or vaccine approval.
The CDC establishes which vaccines get on the recommended pediatric schedule based on decisions by the Advisory Committee on Immunization Practices, which is an independent group of scientists, vaccine experts, public health consultants and other physicians.