Wikipedia:Reference desk/Archives/Miscellaneous/2020 August 13

= August 13 =

Can the US-President order the FDA to approve a vaccine?
So the Gam-COVID-Vac vaccine got me thinking. In light of the current global emergency situation the russian gouvernment has essentially declared, that they are going to skip the entire third phase of human testing, and will start with mass vaccinations pretty much right away without this phase of testing. Could the US-President do the same, and basically order the FDA to aprove a not-fully-tested vaccine for general deployment? Or is there a rule that say that the gouvernment can't tell the FDA to aprove of something the FDA doesn't want to approve? --94.220.114.158 (talk) 12:14, 13 August 2020 (UTC)

Clearly, the President has no direct authority to order the CBER director to make such a determination. Presumably, the head of the FDA, the Commissioner of Food and Drugs, can direct the CBER director to a certain degree and tell them it would be unreasonable and a dereliction of duty to withhold the approval any longer – and then fire them if they do not comply. That would almost certainly be fought in court. I think the head of the FDA is pretty unlikely, though, to direct his underlings to bypass the established procedure at the behest of the President. The President can then fire him and appoint the CEO of Pfizer – or anyone willing to do his bidding. The appointment will have to be confirmed by the Senate, though. --Lambiam 17:38, 13 August 2020 (UTC)
 * The need for an FDA-issued license is anchored in Section 351 of the Public Health Service Act and the procedure for obtaining one is laid down in Section 601.4 of Title 21 of the Code of Federal Regulations. Basically, the latter says that the license shall be issued when the Director of the Center for Biologics Evaluation and Research determines that the vaccine is safe and effective. How the Director is supposed to reach that determination is not prescribed.
 * The Saturday Night Massacre comes to mind. While the president may need Senate approval for a full time appointment I assume in a similar fashion they can just got down the line of interim heads until they find one willing to do what they say. Nil Einne (talk) 21:53, 14 August 2020 (UTC)
 * Some position have restrictions on even who can become an "acting". Trump has had nominees ruled unqualified because of restrictions like not serving 90 days as a subordinate to the position, etc. See Appointments of Homeland Security leaders Wolf and Cuccinelli are 'invalid,' for instance. But the bigger problem would be that no one would take the vaccine if it were approved this way. Too many already say they will not take a properly tested and approved one. Except for perhaps the military, no one is required to take vaccines and losing public confidence would outweigh many of the benefits of simply having a vaccine. Rmhermen (talk) 00:57, 17 August 2020 (UTC)
 * For clarity, I was not intending to suggest the president would choose their preferred subordinate. The point is as with the Saturday Night Massacre. they may not have to if they just keep firing whoever comes next if this person doesn't do what they say. It is of course possible that Congress will eventually intervene by impeaching the president or at least stop them doing what they're trying to do. But this depends how quickly the president manages to cycle through the list which I guess depends how quickly said list is developed. I would assume, but don't know for sure, it could be developed ahead of time assuming you have a president who actually knows how to get advice and plan. So within a day a president could potentially cycle through 50-100 or maybe even more acting heads if necessary. If we put aside the unlikeliness of people accepting such a vaccine (which is secondary to the point of whether it could be done), the main question for such a plan is whether it's possible to run out of people eligible to serve as acting head and what happens when this is the case. Has this ever been tested in real life in some position? In any case, I assume at some stage even most experts will start scratching their heads at who should take over. Mind you, and this was one reason I raised the point, it also seems to me it would be unnecessary to go so far. I would expect within the first 10, probably within the first 5, you'd find someone who would do what the president says then turn around (resigning or not) and explain why they did what they did and how wrong it was for the president to give that order. I.E. somewhat similar to the Saturday night massacre, someone will feel it's better to give in and protect what they can rather than let the president cycle through 100 different heads reaching people less and less prepared for the role. Nil Einne (talk) 15:58, 18 August 2020 (UTC)
 * On the other hand, there are virtually no specific procedures in the Constitution for impeaching a president. If the House was so inclined, they could pass articles of impeachment in 30 minutes. The Senate would have the obstacle of getting the chief justice to preside. I know they can arrest senators and force them to come to the Senate chamber to do their duties. I wonder if they could arrest the chief justice and force him to preside. If so, it could all be over in a few hours. Jc3s5h (talk) 16:06, 18 August 2020 (UTC)
 * The Federal Vacancies Reform Act of 1998 is the applicable law. It seems to suggest that you would have trouble running out of eligible employees as FDA seems to have a larger number of GS-15 and above doctors and scientists. Rmhermen (talk) 16:36, 18 August 2020 (UTC)


 * As a general matter -- and I can't give legal advice in any PARTICULAR situation -- if a goverment agency approves something with no good reason, that decision will be overturned in court under the Administrative Procedure Act (United States). --M @ r ē ino 16:19, 18 August 2020 (UTC)