[Goose]

I liked the old world, in which we could trust the FDA. Yeah, we had the occasional FDA mistake, and there was a whole industry of experts making money on how to influence the FDA. But we've never had serious reason to worry whether or not the FDA is operating with a political agenda. Sad to see this.

Me too. I would alter this to say that the FDA always did operate with a political agenda, but that agenda was mostly to do the best job possible and to not screw up. Sometimes there were behind the scenes back and forth on policy related questions but not political pressure on specific approvals. The problem we have today is that Trump wants to take credit for approvals, so he needs more of them, even if the treatment doesn't actually work. To what extent the FDA will be affected by this desire remains to be seen, but the idea that the president will weigh in on a decisions publicly is an abomination, IMHO.

I also believe it is singularly inappropriate for any employee of the FDA to ever, under any circumstances, tweet about their work. Given how formal the review process is, and how rigid the FDA is regarding document submission, the idea that somebody there would opine casually in public is just absurd. Getting the FDA to answer a direct question in your pre-IND meeting is hard enough, and then it might be OK for somebody to tweet about whatever they feel like? Yet we have this

[tweet]https://twitter.com/stevefda/status/1298071620414824452?s=21[/tweet]

I do however think the Convalescent Plasma EUA was appropriate. It is an emergency use measure, and that use will be monitored. It isn't an approval. The standards are lower and I think it met them (but in fairness I can't know that). I also think that the EUA will be rescinded as soon as an approved monoclonal antibody treatment is available, if not before.

[Goose]

I liked the old world, in which we could trust the FDA. Yeah, we had the occasional FDA mistake, and there was a whole industry of experts making money on how to influence the FDA. But we've never had serious reason to worry whether or not the FDA is operating with a political agenda. Sad to see this.

Me too. I would alter this to say that the FDA always did operate with a political agenda, but that agenda was mostly to do the best job possible and to not screw up. Sometimes there were behind the scenes back and forth on policy related questions but not political pressure on specific approvals. The problem we have today is that Trump wants to take credit for approvals, so he needs more of them, even if the treatment doesn't actually work. To what extent the FDA will be affected by this desire remains to be seen, but the idea that the president will weigh in on a decisions publicly is an abomination, IMHO.

I also believe it is singularly inappropriate for any employee of the FDA to ever, under any circumstances, tweet about their work. Given how formal the review process is, and how rigid the FDA is regarding document submission, the idea that somebody there would opine casually in public is just absurd. Getting the FDA to answer a direct question in your pre-IND meeting is hard enough, and then it might be OK for somebody to tweet about whatever they feel like? Yet we have this

[tweet]https://twitter.com/stevefda/status/1298071620414824452?s=21[/tweet]

I do however think the Convalescent Plasma EUA was appropriate. It is an emergency use measure, and that use will be monitored. It isn't an approval. The standards are lower and I think it met them (but in fairness I can't know that). I also think that the EUA will be rescinded as soon as an approved monoclonal antibody treatment is available, if not before.