NortheasternLaw

@sbagen @NUSL Says @sbagen.bsky.social in the panel on the FDA regulatory environment in #HLC2026 in @NUSL: pre Makary, if you saw how seriously people took their work, it increased confidence (and there were many things to improve).

Says @sbagen in the panel on the FDA regulatory environment in #HLC2026 in @NUSL: government action based on one-sided information rather than full review is concerning. Career people in FDA can be pain - because many people there work hard to go through and ask the questions.

Says @david__simon in the panel on the FDA regulatory environment in #HLC2026 in @NUSL: example: Dr. Makary saw study online, said we call the manufacturers. Concerning!

Says @drsinhaesq in the panel on the FDA regulatory environment in #HLC2026 in @NUSL: drugs approved close to deadline have more safety problems. Now we see this. And Dr. Makary giving bonuses to employees who skip steps in review - troubling.

@sbagen @NUSL Says @sbagen in the panel on the FDA regulatory environment in #HLC2026 in @NUSL: what's going on is pure ideology, and that's really dangerous to what FDA should be.

Says @sbagen in the panel on the FDA regulatory environment in #HLC2026 in @NUSL: also, inconsistency - some see things approving based on nothing, in record time, and then you have vaccines that are incredibly well supported either being delayed or denied.

Says @sbagen in the panel on the FDA regulatory environment in #HLC2026 in @NUSL: we see the voucher process, which allows companies to get around FDA's procedures - waives requirements. The idea of giving someone a pass because they did something for administration - tricky.

Says @david__simon in the panel on the FDA regulatory environment in #HLC2026 in @NUSL: are we seeing deals with FDA by companies, and where is the line between corruption and capture?

Says @rachelsachs.bsky.social in the panel on the FDA regulatory environment in #HLC2026 in @NUSL: if you want to be able to prevent and treat diseases, you want companies to invest.

Says @rachelsachs in the panel on the FDA regulatory environment in #HLC2026 in @NUSL: because drug development path is long, important that companies can trust that advice they get at point A will hold. High turnout - companies report advice from FDA changing, moving goal posts.

Says @DrSinhaEsq in the panel on the FDA regulatory environment in #HLC2026 in @NUSL: unclear Dr. Makary made good appointments. Also unclear if they answer to Makary or Kennedy.

Says @DrSinhaEsq in the panel on the FDA regulatory environment in #HLC2026 in @NUSL: over decades there were great scientists with institutional knowledge and expertise. When Makary appointed 3000 fired - position to make appointments, and they were political.

@rachel_sachs @NUSL @sbagen Says @sbagen in the panel on the FDA regulatory environment in #HLC2026 in @NUSL: if they think that there may be an oddball nominee that Xes their product just because, they won't make same investment decisions, and people will suffer and die.

@rachel_sachs @NUSL @sbagen Says @sbagen in the panel on the FDA regulatory environment in #HLC2026 in @NUSL: there are issues with pharma and big food, but they make products we need - without process/substantive decisions, they'll go out of business or be unable to plan.

@rachel_sachs @NUSL @sbagen Says @sbagen in the panel on the FDA regulatory environment in #HLC2026 in @NUSL: mattered: FDA exists so people can trust the drugs they take and food they eat, and if they can't trust the decisions are based on evidence and good process - bad for FDA legitimacy, and products.

@rachel_sachs @NUSL @sbagen Says @sbagen in the panel on the FDA regulatory environment in #HLC2026 in @NUSL: norm - FDA Commissioner does not intervene in product, those led by centers. Some notable exceptions.

@rachel_sachs @NUSL Says @sbagen, leading the panel on the FDA regulatory environment in #HLC2026 in @NUSL: norm strong, do not want to overstate it- or overstate line between policy and product approval - but norms were strong (in background, administration excepts political loyalty from everyone).

Says @rachel_sachs, leading the panel on the FDA regulatory environment in #HLC2026 in @NUSL: different from policy decisions, where administrations dictate. More comfort of political appointees in this administration to intervene in those.

Says @rachel_sachs, leading the panel on the FDA regulatory environment in #HLC2026 in @NUSL: we often think of FDA as independent of direct politics - norm that political appointees don't intervene in specific product decision. Usually respected across administrations.

Says @david__simon, leading the panel on the FDA regulatory environment in #HLC2026 in @NUSL: Kennedy wants to bring in peptides. Concerning politicization in FDA. Question: how unusual is it for politics to play a role in the FDA?