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👻 Desperately Shrieking Susan 👻

@susanrinkunas.com

Reporter: abortion & politics. Contributing writer, Jezebel. Seen in Slate, The New Republic, The Nation, The Guardian, and more. @wgaeast.bsky.social council. From PA, now in BK. ❤️‍🔥 linktr.ee/susanrinkunas 💌 susanrinkunaswrites @ gmail

7.8k followers1.1k following3.6k posts

DSsusanrinkunas.comOct 11, 2024 10:59pm

The word “shield” appears more than 40 times, though some in footnotes (haven’t read this all I’m picking up dinner bc I was trying to have a NICE NIGHT) storage.courtlistener.com/recap/gov.us...

Screenshot of amended complaint in Alliance for Hippocratic Medicine versus FDA filed on 10/11/24:

a previously approved label.
197 of 199
PRAYER FOR RELIEF
For these reasons, Plaintiff States respectfully request that the Court enter an order and judgment against Defendants, including their employees, agents, successors, and all persons in active concert or participation with them, in which it:
A.
B.
C.
Issues a preliminary injunction or a stay of the effective dates that
reinstates the REMS that were in place before 2016 insofar as they restore the Day 3 and Day 14 follow-up visits, restore the gestational age to 7 weeks from 10 weeks, restore the requirement that prescribers be physicians, and restore the requirement that prescribers must report all serious non-fatal adverse events to the
agency;
2. rescinds the 2019 generic approval; and
restores the in-person dispensing requirement.
Issues a permanent injunction ordering Defendants to withdraw
Defendants' actions to deregulate these abortion drugs.
Holds unlawful, sets aside, and vacates the challenged 2016 Major Changes.
197

Screenshot of amended complaint in Alliance for Hippocratic Medicine versus FDA filed on 10/11/24:

197
198 of 199
Case 2:22-cv-00223-Z Document 194-1 Filed 10/11/24 Page 198 of 199 PagelD 6704
D. Holds unlawful, sets aside, and vacates the 2019 ANDA Approval.
E.
Holds unlawful, sets aside, and vacates the 2021/2023 Removal of the
In-Person
Dispensing
Protection,
including
the Pharmacy
Authorization.
F.
Holds unlawful the provision of drugs to adolescent populations because
the FDA lacked authority under § 355c(a)(2)(B)(i) to extrapolate pediatric effectiveness.
G.
Declares that the Federal Food, Drug, and Cosmetic Act prohibits the FDA from relying exclusively on studies that fail to evaluate the safety
of interrelated changes in the proposed labeling thereof when reviewing and approving a supplemental new drug application without explaining why it was permissible to do so.
H. Declares that 18 U.S.C. § 1461 and 18 U.S.C. § 1462 prohibit the FDA from approving a supplemental new drug application that fails to limit distribution of abortion drugs in accordance with these laws.
I.
Retains jurisdiction of this matter for the purpose of enforcing this
Court's order.
J.
Awards Plaintiffs' costs, attorneys' fees, and other disbursements for this action.
K. Grants any other relief this Court deems equitable, just, and appropriate.

KBkenburnside.bsky.socialOct 11, 2024 11:00pm

Please ignore this until after you've had a nice night, and maybe have an extra glass of whatever beverage lifts your mood!

DSsusanrinkunas.comOct 11, 2024 11:03pm

The AGs from three states—Idaho, Kansas, and Missouri—are very mad about prescribers in so-called shield law states who are writing prescriptions to people in states with abortion bans and sending them in the mail. Yes Comstock is cited. They name drop Aid Access and other services

7:02 ₫
• LTE O
Case 2:22-cv-00223-Z Document 194-1 Filed 10/11/24 Page 76 of 199 PagelD 6582
304. These shield laws often explicitly name mifepristone and the proponents of those laws openly proclaim that they seek to abrogate the sovereignty of Plaintiff
States. 254
1. Aid Access
305. Many abortion providers, like Aid Access, have explained to the press how Defendants' actions have enabled them to frustrate state abortion restrictions and mail FDA-approved abortion drugs "to people in all 50 states, even those (like Missouri] that have banned it. "2
306. Mailing FDA-approved abortion drugs is new for Aid Access. In the past,
Aid Access did not mail FDA-approved abortion drugs.
307. When Aid Access was started in 2018, it operated as a black-market provider of abortion drugs from India. "FDA regulations prevented licensed US providers from mailing mifepristone, one of the two drugs in the medication abortion regimen, so Aid Access was structured like. telemedicine service." 230
308. But then in 2021 the "in-person dispensing requirement for mifepristone" was removed, 257 Aid Access responded to the FDA's 2021 change by entering the U.S. market as a provider of FDA-approved abortion drugs by mail in certain states. "For the first time, legally prescribed medication abortion could be put in the mail. Aid Access used this opportunity to implement a hybrid model: in states
254 Id.
235 Ex. 62, Rebecca Grant, Group Using 'Shield Laws' to Provide Abortion Care in States
That
Ban
It,
The
Guardian
(July
23,
2023),
https://www.theguardian.com/world/2023/jul/23/shield-laws-provide-abortion-care
aid-access.
256 Id.
237 Id.
76
Case 2:22-cv-00223-Z Document 194-1 Filed 10/11/24 Page 77 of 199 PagelD 6583
where telemedicine abortion was legal, US clinicians handled the prescriptions, while in states where it wasn't, the pills continued to be mailed from India."238
309. Later, after the FDA's 2023 permanent removal of in-person dispensing safeguards, Aid Access expanded its scope a…

👻 Desperately Shrieking Susan 👻

@susanrinkunas.com

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