FDA Expands Approval of Gene Therapy for Patients with Muscular Dystrophy | Hacker News Reader

FDA Expands Approval of Gene Therapy for Patients with Muscular Dystrophy

fda.gov

25 pointsjordanpg6 comments

I think we need to begin to use specific names when talking about approval processes, rather than just lumping everyone under the same "FDA" brand. E.g. Are certain people in the organizational structure have a history of fraud being detected, drugs being recalled vs. others who were involved perhaps at every step of oversight and 0% of the drugs approved with their involvement have never had recalls?

Not being specific with language appears to, whether purposefully done or due to a lack of discipline, add a prominence or add a label or brand on top of a pedestal - maybe deserved to be done so by some of an organization's people - but then others new to an organization with unknown track records, their work then will ride on the coattails of an institution with a certain reputation (whether accurate or not, whether deserved or not).

Edit to add: Have a contrary opinion worth anything? Prove it by sharing it in writing.

This is a press release. It's signed by the head of the specific FDA department, who's ultimately responsible for the decision.

The FDA documents its process with a bunch of memos. They name the committee, and their supervisors:

https://www.fda.gov/media/179486/download?attachment

The actual committee members are rank-and-file FDA employees. They're GS-scale civil servants. You can go look them up if you think they're somehow biased.

Pharma was eye-opening (and, personally, infuriating) regarding problems with the FDA, drug approvals, individual inspectors, the industry-to-regulator (or vice versa) revolving door, and so on. You're not wrong that there are problems within the system and the individuals that work within it.

However, considering things like the polarized political climate, or certain parties proposals to tear the administrative branches apart I don't believe it would be productive to highlight or put forward the names of specific individuals within agencies like the FDA. I do think more public scrutiny or just light shedding upon the process could be good, but I don't see how enabling a raft of death threats or public name dragging would help.

I think one thing that will change moving forward is there will no longer be unelected administrative positions in these bureaucracies like how Fauci was in his position for what, 50 years?

Seek help.

How insightful.

“Your boos mean nothing to me, I've seen what makes you cheer” - Rick, Rick & Morty

P.S. You realize that ad hominem is only used by those who are immature?

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