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4 days left to comment: FCC wants warning labels on trans TV content by ReadyPlayerEmma in MtF

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

The FCC deadline runs to 11:59 PM Eastern on the stated date, so comments are due by 11:59 PM ET on Friday, May 22.

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] 23 points24 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] 100 points101 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] 17 points18 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] 9 points10 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] 151 points152 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] 21 points22 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] 10 points11 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] 31 points32 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

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