To me, it’s a way more interesting conversation than the 105th debate on mask efficacy, but no one seems all that interested in having it. (And by no one, I’m talking about the media/society in general, not this message board).
This is arguably the most visible, widespread medical emergency of most of our lifetimes…if the FDA process is too slow and burdensome here, and if the agency’s only wins were the places where they suspended their usual operating procedures, it’s scary to think of its daily impact on people who are suffering from diseases not on the news 24/7.
Post COVID, we should be having a national debate about the costs and benefits of the agency and it’s standards. Yes, it’s (probably) protecting from horrible side effects from new drugs in some cases, but how about the cost side of the ledger? How many people are suffering because we’re not allowing them access to something that might help them? How many drugs are never developed because the torturous FDA process works as a disincentive to development?
Do we need a process that tests for safety, then efficacy, then safety + efficacy together? Can we skip right to stage 3? Should we test for efficacy at all, risk that people will be sold the occasional magic pill that does nothing, but benefit from those who get an effective medicine before it’s too late? Should we allow people to use interventions that were approved by other highly developed Western countries rather than wait for the FDA to sort through paperwork?
There are a lot of tough moral questions to answer, but ignoring them doesn’t make them go away…all we’ve done is saddle a government agency with the burden of answering them. It’s not surprising that they err on the side of risk aversion, but at some point I hope people will at least question whether this is the right thing to do.
