It seems that for approving vaccines there's a gap of weeks between the drug company finishing their trial and giving the data to the FDA and the FDA actually making the decision to approve the vaccine. What does the FDA do during that time? What takes weeks?
I think this post is really valuable because it pushes people to be in information-seeking mode, rather than hortatory mode. And I’m sorry to see that I’m the only one who’s tried to answer the question, because I’m sure my answer is incomplete.
I’d like to encourage other people to really try to think and learn about why the FDA is acting this way. What is happening and why? What procedures and incentives are they operating with? Don’t jump straight to criticizing them, don’t jump to what you would do if you built the system from scratch. (And no, “fire everybody and replace them with AI” is never going to fly in the federal government.)
If this is ever going to change, we need to know what’s happening first.
I’d love to hear from someone at FDA on this. I do not work for FDA, but here’s my guess.
they need to study the data they’ve been given. Although FDA will have been in communication with the drug company and seen their data all along, they probably have a rule that they can only consider data Officially Submitted as part of an Official Application. In a complex organization, most likely lots of people get involved in a big decision, including managers, lawyers, and political appointees who don’t necessarily have a lot of value to add on safety/efficacy questions but who do have enough organizational clout to ensure they don’t get bypassed even in an emergency. I’d guess for sufficiently big decisions, conversations happen with Congressional and White House staffers too.
Legal requirements for notice. FDA might have to give the public notice that they are considering the approval. And the FDA has an advisory committee on vaccines, and they are required to give notice of those meetings so that the public has a chance to attend. There are probably emergency bypasses to these notice requirements, but no one is particularly incentivized to take the risk of departing from normal process.
This comment intended as description, not justification, of the existing practices.
Whatever else is going on... the FDA has never been graded on speed, and plenty of ink has been spilled in non-covid times about how many people die, and how many QALYs are lost, because of delays that make little difference to the eventual outcome, but look to the general public like Serious People Making Decisions Carefully. They permit themselves the time, and with it buy a mantel of authority in the public eye.
Also... looking at the VRBPAC online meeting calendar, it looks like they plan out their meetings several months in advance. I assume normally this is to ensure that members can align their schedules. Does anyone know how far in advance the seemingly-weeks-delayed-meetings were scheduled? Before or after the data from trials gets officially submitted? I'm wondering if they just have recurring meetings on the topic and wait to talk at the next one, or if their standard practice is to always schedule meetings at least a few weeks out for their own convenience, or what.
This past year we removed many but hardly all of the more useless regulatory barriers to testing and approval the vaccines. Is there any reason the FDA couldn't have been auditing the data and the trial process all along (other than "they're not set up to do that or aren't allowed to")? "We need weeks to confirm the data are authentic and check your math" just isn't plausible during a pandemic when there's no scientific reason that has to wait until the very end.
A politician can choose between two messages that affirm their loyalty: Advocating a beneficial policy, or advocating a useless and wasteful policy. They choose useless, because the motive behind advocating a beneficial policy is ambiguous. Maybe they wanted people to benefit!