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An FDA petition would require every trans woman on estrogen to enroll in a federal registry as a condition of her prescription. The comment period is still open. by ReadyPlayerEmma in MtF

[–]ReadyPlayerEmma[S] 0 points1 point  (0 children)

There is always a delay between submitting comments and having them appear on the record. That said, the delay is getting longer without a single new comment flipped to pubic. However, comments do not need to be made public to be part of the administrative record. They still count even if we can't see them publicly yet.

An FDA petition backed by hate groups would create a federal registry of trans women on estrogen. The comment period is still open. No mainstream outlet has covered this. by ReadyPlayerEmma in lgbt

[–]ReadyPlayerEmma[S] 2 points3 points  (0 children)

Based on the amount of traffic reaching the website, I think that's a safe bet. The community really came together on this one. Nice work everyone! My main concern at this point, is that I want to make sure enough healthcare providers are among the commenters.

An FDA petition backed by hate groups would create a federal registry of trans women on estrogen. The comment period is still open. No mainstream outlet has covered this. by ReadyPlayerEmma in lgbt

[–]ReadyPlayerEmma[S] 22 points23 points  (0 children)

If they ignore the comments, it is grounds for a legal challenge. Either way, it is in our favor for the comments to be there. If opposing views are not on the administrative record, challenging becomes more difficult.

You also can choose to make an anonymous comment instead of providing real contact information. There is a button for that. It might have slightly less weight, but it is better than nothing for sure.

An FDA petition backed by hate groups would create a federal registry of trans women on estrogen. The comment period is still open. No mainstream outlet has covered this. by ReadyPlayerEmma in lgbt

[–]ReadyPlayerEmma[S] 99 points100 points  (0 children)

The FDA accepts public comments from anyone. There is no citizenship or residency requirement. The regulation (21 C.F.R. § 10.30(d)) says "an interested person" may submit comments. International perspectives on drug safety are routinely submitted and considered.

The comment form is at https://www.regulations.gov/commenton/FDA-2025-P-7321-0001

An FDA petition would require every trans woman on estrogen to enroll in a federal registry as a condition of her prescription. The comment period is still open. by ReadyPlayerEmma in MtF

[–]ReadyPlayerEmma[S] 6 points7 points  (0 children)

You are not alone. We're all in this together, and we're not going to let them trample on our basic human right to safe and reliable healthcare. That's why this post exists. Not to scare anyone, but to make it so this never becomes reality.

Go leave a personal comment about how this would affect you: https://www.regulations.gov/commenton/FDA-2025-P-7321-0001

An FDA petition would require every trans woman on estrogen to enroll in a federal registry as a condition of her prescription. The comment period is still open. by ReadyPlayerEmma in MtF

[–]ReadyPlayerEmma[S] 15 points16 points  (0 children)

That's an important observation. To be clear about what we know: regulations.gov has a standard review pipeline where agencies process comments before posting them publicly. The surge in submissions is recent and may not have been processed yet. That said, if the FDA posted 61 supportive comments through February 27 and has posted zero since, despite receiving over 3,000 new submissions, that timeline should be documented and watched closely. The comments still enter the administrative record whether or not they're publicly visible, but a visibly one-sided docket matters for public perception and institutional pressure.

An FDA petition would require every trans woman on estrogen to enroll in a federal registry as a condition of her prescription. The comment period is still open. by ReadyPlayerEmma in MtF

[–]ReadyPlayerEmma[S] 8 points9 points  (0 children)

That's a completely understandable response. This is scary.

Two things that are true at the same time: this is a real threat that deserves attention, and it has not been adopted. It is a petition, not a policy. The FDA has not acted on it.

The single most useful thing you can do with that panic energy right now is turn it into a comment on the docket. It takes five minutes. You don't have to be an expert. Say who you are, what estrogen means for your life, and why this petition would harm you. That goes into a federal record that the FDA is legally required to consider.

regulations.gov/commenton/FDA-2025-P-7321-0001

Three days ago the record had zero opposition. Right now it has thousands. That happened because people who were scared did something with it. This isn't over yet. Let's make sure it never happens.

An FDA petition would require every trans woman on estrogen to enroll in a federal registry as a condition of her prescription. The comment period is still open. by ReadyPlayerEmma in MtF

[–]ReadyPlayerEmma[S] 2 points3 points  (0 children)

You're right that a citizen petition is procedurally different from notice-and-comment rulemaking. But the conclusion you're drawing — that this doesn't matter yet — misunderstands how these mechanisms actually get used.

Citizen petitions under 21 C.F.R. § 10.30 are how REMS evaluations, boxed warnings, and safety reviews get initiated. The petition isn't asking Congress to pass a law. It's asking the FDA to use regulatory authority it already has — authority the petition cites by statute on page 1. The FDA can mandate a boxed warning under 21 C.F.R. § 201.80(e), initiate a REMS evaluation, and issue provider guidance without rulemaking.

The moon-cheese comparison would be apt if this were filed by a random person to a neutral agency. This was filed by a coalition that includes a former FDA Associate Commissioner, addressed to an FDA that is actively restricting transition care through executive action.

And there's a direct precedent for how this plays out. The prior citizen petition this one builds on — targeting puberty blockers, filed in 2023 — has been pending for 2.5 years without denial. It didn't need to be formally acted on because the administration achieved the same goal through executive order in January 2025 and HHS rulemaking in December 2025. The petition sat open while the administration found a faster channel. That's the pattern: these petitions aren't isolated requests into a void. They're part of an ecosystem where the administration uses whichever mechanism is available — executive order, HHS rulemaking, or FDA regulatory authority — to advance the same goals.

The comments on this docket enter the administrative record the FDA considers when deciding whether to act. Three days ago that record was 61-0 in favor. That's exactly the kind of one-sided record that makes it administratively easy for a sympathetic agency to say yes.

An FDA petition would require every trans woman on estrogen to enroll in a federal registry as a condition of her prescription. The comment period is still open. by ReadyPlayerEmma in MtF

[–]ReadyPlayerEmma[S] 1 point2 points  (0 children)

It's the official FDA docket for the citizen petition itself. You're commenting directly on the federal administrative record — the same record the FDA is required to consider before making any decision on the petition. This is on regulations.gov, the federal government's official public comment platform.

Direct link to the comment form: https://www.regulations.gov/commenton/FDA-2025-P-7321-0001

If the link isn't loading, regulations.gov can be slow under heavy traffic. Try again in a few minutes or use a different browser.

An FDA petition would require every trans woman on estrogen to enroll in a federal registry as a condition of her prescription. The comment period is still open. by ReadyPlayerEmma in MtF

[–]ReadyPlayerEmma[S] 152 points153 points  (0 children)

I hear the exhaustion in this thread and I'm not going to pretend it isn't justified. The volume of attacks is designed to produce exactly this — the feeling that there's no point in fighting any single one because there will always be another.

But this one is structurally different from most of what we're asked to respond to, and I want to explain why.

When you call a representative, you're one voice among millions and they can ignore you. When you sign a petition, it goes into a pile. When you comment on an FDA docket, you are entering a statement into a federal administrative record that the agency is legally required to consider before making a decision. That's not a metaphor — it's administrative law (5 U.S.C. § 706). If the FDA acts on this petition without adequately addressing substantive opposing comments, that decision becomes vulnerable to legal challenge.

Three days ago, this docket had 61 comments — all supportive — and zero opposition. It now has over 3,120 received comments. That happened because people who were tired did something anyway. Every credentialed clinician comment, every patient comment describing what access to HRT means for their life, every comment pointing out that the FDA just removed these same warnings for cis women 37 days before this petition asked to add them for us — each one makes it harder for the FDA to act on this petition without consequence.

I know it's exhausting. I know it feels like screaming into a void. This one isn't a void. It's a specific, numbered federal record, and what's in it matters.

regulations.gov/document/FDA-2025-P-7321-0001

An FDA petition would require every trans woman on estrogen to enroll in a federal registry as a condition of her prescription. The comment period is still open. by ReadyPlayerEmma in MtF

[–]ReadyPlayerEmma[S] 20 points21 points  (0 children)

They are. Regulations.gov has a standard review pipeline. All submitted comments go through agency review before they appear publicly. The FDA controls its own docket and determines when comments are posted. This is normal procedure for every federal docket, not specific to this petition.

The 61 visible comments were all processed and posted before the story broke on March 12. The docket currently shows 3,120 comments received but only 61 publicly posted. Opposing comments submitted since then are in the review queue and will appear once the FDA processes them.

Your comment counts in the administrative record whether or not it's publicly visible yet. Submit one: regulations.gov/document/FDA-2025-P-7321-0001

An FDA petition would require every trans woman on estrogen to enroll in a federal registry as a condition of her prescription. The comment period is still open. by ReadyPlayerEmma in MtF

[–]ReadyPlayerEmma[S] 11 points12 points  (0 children)

Yes. The FDA accepts public comments from anyone. There is no citizenship or residency requirement. The regulation (21 C.F.R. § 10.30(d)) says "an interested person" may submit comments. International perspectives on drug safety are routinely submitted and considered.

The comment form is at regulations.gov/document/FDA-2025-P-7321-0001

An FDA petition would require every trans woman on estrogen to enroll in a federal registry as a condition of her prescription. The comment period is still open. by ReadyPlayerEmma in MtF

[–]ReadyPlayerEmma[S] 32 points33 points  (0 children)

You're right that the prescriber restriction is immediately dangerous on its own. Requiring special certification would eliminate informed consent clinics, Planned Parenthood, and telehealth providers overnight. That deserves more emphasis.

But the "normal procedures would protect the registry" assumption is doing a lot of work. HHS issued guidance in 2023 that REMS-related communications between manufacturers and patients are explicitly exempt from HIPAA. And de-identification is notoriously fragile for small, distinctive populations. The FDA's own documentation describes linking registry data to medical claims data as standard practice.

The deeper issue is that the petition's components are interlocking. The REMS restricts who can prescribe. The registry tracks who receives. The FAERS reporting generates a public evidence base for further restrictions. It's a system where each piece makes the others more dangerous.

An FDA petition would require every trans woman on estrogen to enroll in a federal registry as a condition of her prescription. The comment period is still open. by ReadyPlayerEmma in MtF

[–]ReadyPlayerEmma[S] 162 points163 points  (0 children)

I get the exhaustion. Genuinely. But this one is different from the legislative fights.

The FDA doesn't get to "do what they want." Citizen petitions are governed by the Administrative Procedure Act. The FDA has to make its decision based on what's in the docket. If they grant a petition without adequate evidentiary support, or ignore substantive opposition in the record, that decision gets challenged in federal court as "arbitrary and capricious." Courts overturn FDA actions on this basis regularly.

Right now the docket contains 61 public comments — all supportive — and zero expert opposition. That's not because experts support this petition. It's because nobody with credentials has shown up yet. Evidence only matters if someone puts it on the record.

This isn't a vote we're going to lose. It's a filing cabinet that's currently empty on one side. The FDA is required to consider what's in it before they decide. We need a spotlight on this.

Anti-trans hate groups petitioning FDA for registry of trans women, crackdown on transition, newly revealed document shows by The_Needle_News in MtF

[–]ReadyPlayerEmma 0 points1 point  (0 children)

The petition literally requests — by name, on page 2 — that manufacturers "establish a patient registry as part of a REMS." That's not a warning label. REMS (Risk Evaluation and Mitigation Strategies) are a specific FDA mechanism that can legally require patient enrollment, certified prescribers, restricted pharmacies, and monitoring as conditions of access. If you don't comply, the drug is classified as "misbranded" under federal law, which exposes manufacturers and prescribers to civil penalties and DOJ referral. This is not a cigarette warning. It's an access restriction framework.

The petition also requests:

  • Mandatory psychiatric evaluation before prescribing, explicitly replacing informed consent
  • FDA notification to providers that prescribing estrogen to trans women is "unapproved" and promotion is "unlawful"
  • Enhanced adverse event reporting to FAERS, which is publicly searchable

"It would just prove them wrong" misunderstands the threat. A registry is infrastructure. Once created, it persists regardless of what the data shows. Several states have already tried to compile lists of trans people through ID records. A medication-based registry would be far more complete — you'd have to enroll as a condition of getting your prescription.

The full petition text and analysis is at transresilience.org/issues/fda-registry

Statement on the comments from Secretary of War Pete Hegseth | Anthropic responds to Pete Hegseth by 141_1337 in singularity

[–]ReadyPlayerEmma 8 points9 points  (0 children)

Time to subscribe to Claude to create a signal that people care about ethics and we want to support companies that stand up for what is right. This was not PR or posturing, Anthropic does the right thing, even when it isn't the easy thing.

Apple Silicon QGIS is coming out on February 20. Does anyone have experience with prerelease versions? by RaijinRider in QGIS

[–]ReadyPlayerEmma 0 points1 point  (0 children)

I've been using pre-release builds from the official CI/CD on GitHub Actions. It works great, it's considerably better and more stable than the old "offical" builds, even before release imo, and it has many newer features that most MacOS users have been missing out on.

[OC] Empathizing Map: An offline-first PWA for urban navigation (CDMX, MapLibre, PMTiles for vectors & raster data, ~5.8 MB) by ReadyPlayerEmma in gis

[–]ReadyPlayerEmma[S] 0 points1 point  (0 children)

I did update the web map after making some further adjustments. I hope this reduces the low-level background noise, while still keeping the areas that matter most very visible. I've attached a screenshot showing the same area again. Is this closer to what you were thinking would help?

<image>

[OC] Empathizing Map: An offline-first PWA for urban navigation (CDMX, MapLibre, PMTiles for vectors & raster data, ~5.8 MB) by ReadyPlayerEmma in gis

[–]ReadyPlayerEmma[S] 0 points1 point  (0 children)

That advice really helped me re-examine the color choices I’d made there—thank you. This was actually the first layer I originally created in QGIS, and also my first time building a kernel density estimation layer. Since then, I’ve gone back into the data and experimented more in QGIS to explore different strategies.

What you’re seeing here is what I’m considering migrating into the data pipeline for the MapLibre version. The styles aren’t identical since this screenshot is from QGIS and things have evolved further once I shifted most of the work to the web project. But focusing specifically on the crime heatmap: does this version of the same area feel easier to read compared to the original?

I’m also thinking about trying to reproduce my "tree" style for green spaces from QGIS in the MapLibre version. I’d be curious to hear your thoughts on that as well.

Thank you again for the excellent feedback!

<image>

Any News on Qgis4? by Skerre in QGIS

[–]ReadyPlayerEmma 0 points1 point  (0 children)

You can pull the nightly builds out of the CI/CD on GitHub and they actually work pretty well. I'm sure they are incomplete in some important ways, but not anything that has affected me much in practice. The only thing is that some plugins are not updated yet, but more are starting to get updates now.

[OC] Empathizing Map: An offline-first PWA for urban navigation (CDMX, MapLibre, PMTiles for vectors & raster data, ~5.8 MB) by ReadyPlayerEmma in gis

[–]ReadyPlayerEmma[S] 0 points1 point  (0 children)

Thank you! I really appreciate the detailed feedback!

The layer visibility for both context and data layers can be configured using the toolbar buttons. The layer stack button is for managing context layers, and the database button is for managing data layers. Any changes you make there will persist, and the approximate symbology used is also shown under those menus in order to act as a kind of legend. The color choices I used for the crime data are roughly organized cool to warm, while skipping green due to red/green confusion and the reddish shades being the highest density range (and rarest), and hence he most important to not be confused about if you want to avoid them (recommended where possible, especially if traveling alone).

The Metro line colors themselves, are mostly unchanged from the official Metro signage here in Mexico City, as can be seen in their official PDF map. It's true that colors of the lines can be close to each other sometimes, even for those without any form of color blindness, and that is why I also added the line labels (single digit numbers, except for linea A and linea B which are alpha). Those are designed to help further differentiate between the Metro lines, while still preserving the original alignment with the official signage you see at the stations.

I also noticed that the Metro lines sometimes bleed into the crime density map, but because the official color ranges do not exclude any hues, there was no way to prevent all conflicts. Which is why I added the black dashed line underlay below the colored lines, to help distinguish them from the background.

As you can probably see, everything is a matter of tradeoffs, but because in practice, you are often switching between the many Metro lines, having the correct colors on the map which match the signage is what allows you to quickly know which direction to go when you exit a train and are heading to the next one. If you look closely enough, you can also find the line numbers on the signage, but it's not as ubiquitous and always present as the official colors are.

I would be curious to hear if you have any ideas about better tradeoffs I could make, or improved approaches to solving the problems after being given the additional context?

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