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March 3rd, 2023:

Democratic AGs file lawsuit to ease access to mifepristone

Good, albeit a bit confusing at this point in time.

A dozen Democratic state attorneys general have opened a new front in the legal war over mifepristone, the “gold standard” medication used in the majority of all US abortions. In a federal lawsuit filed Thursday, the AGs—from states including Arizona, Illinois, and Washington—accuse the Food and Drug Administration of imposing unnecessarily “onerous” restrictions on mifepristone, which is used in combination with the anti-ulcer drug misoprostol to end pregnancies in the first 10 weeks.

The drug has a sterling safety record and has been used by an estimated 5.6 million people since it was approved by the FDA more than 22 years ago. Nevertheless, the FDA has long subjected mifepristone to a set of unusual restrictions known as a “Risk Evaluation and Mitigation Strategy” (REMS). The agency only applies these extra rules, such as a requirement that prescribers receive a special certification, to a few dozen drugs—typically high-risk medications like opioids, or injectable anti-psychotic sedatives. The inclusion of mifepristone on this list has long been controversial. “Many people believe that the strict restrictions on mifepristone reflect political concerns more so than concerns around the safety of the drug itself,” Temple University law dean Rachel Rebouché told me in June, the day the Supreme Court overturned Roe v. Wade.

Since then, a dozen states have outlawed abortion almost entirely. Medication abortion has only grown in importance as people who want to end their pregnancies in abortion-hostile states source the pills through telehealth, mail-forwarding services, and overseas pharmacies.

Yet while the FDA has recently loosened some of its rules on mifepristone—for instance, by allowing certified pharmacies to dispense it—the REMS remains in place. “FDA’s decision to continue these burdensome restrictions in January 2023 on a drug that has been on the market for more than two decades with only ‘exceedingly rare’ adverse events has no basis in science,” argues the complaint from the attorneys general. “It only serves to make mifepristone harder for doctors to prescribe, harder for pharmacies to fill, harder for patients to access, and more burdensome for the Plaintiff States and their health care providers to dispense.”

This isn’t the only legal battle over mifepristone. For the few weeks, abortion rights advocates have been waiting and watching as an anti-abortion, Trump-appointed judge in Texas considers issuing a nationwide ban on the drug. That case—brought by the religious-right legal group Alliance Defending Freedom—claims that the FDA “exceeded its regulatory authority” when it approved mifepristone in 2000; that the agency had overlooked potentially harmful side effects; and that a 19th-century anti-obscenity law forbids the mailing of abortion drugs. If the judge agrees and issues a temporary injunction, which he could do any day, mifepristone could be taken off the market everywhere from New York to California.

That case, about which I’m sure you’ve already read at least two alarmist articles, is the reason I’m a little confused by this. Who even knows what happens if that whackjob judge in Texas decides to make medication abortion illegal across the country? That said, I do appreciate an effort to go on the offensive. Daily Kos adds on.

The suit is spearheaded by Oregon Attorney General Ellen Rosenblum and Washington Attorney General Bob Ferguson. In January, the FDA updated the risk evaluation and mitigation strategy (REMS) for mifepristone to life the requirement that patients pick the medicine up in person from a pharmacy, making it simpler for pharmacies to fill the prescriptions online and through the mail. But the FDA kept a requirement under REMS that forces prescribers to obtain specific certifications, and requires extensive documentation that the AGs say could endanger both providers and patients.

The paper trail “puts both patients and providers in danger of violence, harassment, and threats of liability amid the growing criminalization and outlawing of abortion in other states,” the complaint states. That paperwork puts an unnecessary burden on healthcare providers and on patients, the AGs say in the suit.

Under the REMS, both doctor and patient are required to sign an agreement saying that the drug is being prescribed and the patient intends to take it to end a pregnancy. It doesn’t distinguish between an abortion or treatment for a miscarriage, and that agreement stays in a patient’s medical record.

The lawsuit also points out that there are just 60 drugs among more than 20,000 regulated by the FDA that it has imposed REMS on, that “cover dangerous drugs such as fentanyl and other opioids, certain risky cancer drugs, and highdose sedatives used for patients with psychosis.” It is “improper and discriminatory for FDA to relegate mifepristone … to the very limited class of dangerous drugs that are subject to a REMS.”

“FDA’s decision to continue these burdensome restrictions in January 2023 on a drug that has been on the market for more than two decades with only ‘exceedingly rare’ adverse events has no basis in science,” the AGs lawsuit says. “It only serves to make mifepristone harder for doctors to prescribe, harder for pharmacies to fill, harder for patients to access, and more burdensome for the Plaintiff States and their health care providers to dispense.”

“In this time when reproductive healthcare is under attack, our coalition of 12 states seeks to ensure that access to mifepristone—the predominant method of safe and effective abortion in the U.S.—is not unduly restricted,” Rosenblum said in a statement. “Our coalition stands by our belief that abortion is healthcare, and healthcare is a human right.” The other states joining the suit, filed in the Eastern District of Washington state, are Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Rhode Island, and Vermont.

The suit was filed in the Eastern District of Washington. I’d like to think that if the plaintiffs gets a favorable ruling, the FDA will not appeal. We’ll see where we even are when that happens.

Former Land Commissioners oppose anti-Open Beaches bill

From the inbox:

Among coastal states Texas is unique. The 1959 Texas Open Beaches Act (TOBA), as well as time-honored common law and tradition in existence since long before 1959, provides that Texas beaches are open to the public. In 2009, Texans voted by a 77% to 23% margin to enshrine TOBA into the Texas Constitution.

Unfortunately, public access to Texas beaches may soon end if legislation filed in Austin passes into law.

Senate Bill 434, by Senator Mayes Middleton of Galveston, would strip the authority of the Texas General Land Office (GLO) to define the boundaries of the public beach and would allow the upland beachfront property owner to make that determination. The property owner could then deny access to the public beach easement that existed between the line of vegetation (LOV) and the mean high tide mark. That would then limit Texas beachgoer’s access to only what is known as the “wet beach” – the area between the low tide and the high tide lines. When that area is washed by waves during periods of high tide, SB 434 would result in there being no beach at all for Texans to use.

If SB 434 passes, don’t be surprised if you show up at your favorite beach spot and you’re confronted with a fenced off beach or no trespassing signs. The only remedy available to you then would be a suit against the adjacent upland landowner. Yes, on your next trip to the beach you should consider bringing along your lawyer. You should also be prepared to drag your kids, your cooler, and your beach gear through the shallow tidal waters in order to enjoy the beach.

Beachfront property owners can’t claim ignorance of the public beach easement. Since 1986 they have received notice of the public beach easement in the documents they signed at closing.

Ironically, SB 434 doesn’t just hurt Texas beachgoers, it hurts beachfront property owners as well. Public money must be spent for a public purpose. The GLO and local governments will be unable to spend money on improving property with no public access. There will be no beach renourishment projects, no beach cleanup, and no beach maintenance in areas where property owners claim the beach has no public access easement. There is currently an expansive beach renourishment project ready to go at Jamaica Beach on Galveston Island that will be cancelled. In addition, developers of coastal property will be handicapped if the GLO is no longer able to determine survey data needed to designate set back lines for coastal construction.

Please join us in opposing SB 434. Contact your State Senators and State Representatives. You can find their contact information at Texas Legislature Online at www.capitol.texas.gov.

God Bless Texas,
David Dewhurst, Garry Mauro and Jerry Patterson, Former Texas Land Commissioners

I get a lot of unsolicited requests to run op-eds here, the vast majority of which come from bots and SEO-addled PR flaks who wouldn’t know me from a Buzzfeed listicle. This one came from someone I do know, former Land Commissioner Jerry Patterson, who I spoke to several times during his tenure. We absolutely disagree on a lot of policy matters, but I always respected him as Land Commissioner, and he ran an open and transparent office. On the matter of the Texas Open Beaches Act, we are in firm agreement. I’ve blogged about it before, most recently after a couple of lousy SCOTx opinions that weakened the Open Beaches Act. I’m happy to cosign this.

Here’s SB434. I have not seen any public statements from the current Commissioner, Dawn Buckingham, about this bill, but all indications are that she opposes it and supports public beach access along with these three and unlike her immediate predecessor, George P. Bush. Hopefully that will carry some weight. In the meantime, it can’t hurt to tell your legislators that you also oppose this bill and hope that they will stand for keeping Texas’ beaches open, as they should be.

UPDATE: The op-ed is in the Chron as well. But you saw it here first.

HCC will hire a new Chancellor

Interesting.

The Houston Community College System Board of Trustees voted on Wednesday not to extend the contract of Chancellor Cesar Maldonado.

The trustees’ decision was close: Four voted in a special meeting to consider a new contract and five opposed. Board Chairwoman Cynthia Lenton-Gary was against the contract, as were District IV Trustee Reagan Flowers, District V Trustee Robert Glaser, District VI Trustee Dave Wilson and District IX Trustee Pretta VanDible Stallworth.

It was not immediately clear why the majority declined to continue their relationship with Maldonado. The trustees’ vote occurred after more than one-and-a-half hours in executive session, and neither Maldonado nor the trustees made public comments before the decision.

Maldonado’s contract expires Aug. 31.

“Chancellor Maldonado has had a notable nine-year run, in part, expanding student achievement, ensuring a high credit rating for our institution, forging value-added partnerships with the community, and expanding the mission, vision and strategic priorities of HCC,” Lenton-Gary, also the District VII trustee, said in a statement. “On behalf of the HCC governing board, we celebrate the successes of HCC under the leadership of Dr. Cesar Maldonado and extend our gratitude for his leadership and longstanding service as HCC’s Chancellor.”

While Maldonado oversaw several physical expansions at HCC, his time at the system will also be marked by multiple shakeups in the board and controversies in the administration.

[…]

At least one lawsuit rose to public attention in 2021, after a former instructor accused Maldonado and the system of retaliating against her for reporting that she was being sexually harassed by board member Robert Glaser. Most recently, the system has struggled to maintain steady enrollment, having lost more than 12,000 students between fall 2019 and fall 2020.

The contract vote on Wednesday passed without many visible reactions from the trustees. Only District III Trustee Adriana Tamez spoke afterward, saying she was upset enough to not participate in a subsequent vote to engage the Association of Community College Trustees for a new chancellor search. The item passed 7-0, with District VIII Trustee Eva Loredo also making herself absent for the vote.

“Chancellor, I sincerely apologize that you were brought out here like this,” said Tamez, who voted in favor of a new contract. “I’m just in disbelief and in shock right now in terms of conversations that we’ve had and your willingness to work with us in a transition. But to have you here and for the result to be this, I think you deserve more respect than that.”

Loredo, Vice Chair Monica Flores Richart, of District 1, and District II Trustee Charlene Ward Johnson cast the three other votes in favor of Maldonado’s contract.

Campos is pissed about this. I can understand that, and I will say that any time Dave Wilson is your fifth vote for something, you should maybe question what you’re doing. On the other hand, there’s that sexual harassment lawsuit, for which Maldonado is one of the defendants (as is Trustee Robert Glaser, who was also a vote for not extending Maldonado’s contract) and for which a settlement agreement was not approved by the Board. The matter is headed for trial, which raises the possibility of a significant judgment against HCC as well as who knows what potentially embarrassing evidence coming to light. Given that, it’s easy to see why the Board may have been reluctant to extend Chancellor Maldonado’s contract. We’ll see who they bring on as the successor. In the meantime, I thank Chancellor Maldonado for his service and wish him well with whatever comes next.

Dispatches from Dallas, March 3 edition

This is a weekly feature produced by my friend Ginger. Let us know what you think.

This week in DFW, our most interesting story is a brouhaha in Frisco ISD, but we also have an interview with Sarah Weddington’s co-counsel in Roe v. Wade, trouble with the Dallas SPCA, local elections news, including speculation about who’ll go for Colin Allred’s seat if he takes on Ted Cruz, and more. Be sure to scroll down for a link to a picture of bald eaglets!

Marvin Lowe, a Frisco ISD trustee elected in the May 2022 cycle, had some kind of interaction with a trans student from Brownsville at a statewide educational conference in September of last year. The student reports that Lowe said a number of inappropriate things, he’s backed up by his mother and at least two other adults, and he and his family seem to have gone through official channels until last week, when they spoke to the Dallas Morning News [Archive link] because they weren’t getting any satisfaction. Lowe apparently talked about his “junk” and naked people in locker rooms and people getting aroused to the student; also, according to everybody but Lowe, an activist had to intervene to get Lowe to leave the then sixteen-year-old student alone.

Lowe didn’t want to talk to the DMN, but the subject came up at a Frisco ISD board meeting on February 26 (Frisco Star), exciting significant controversy from speakers. Lowe denied everything at the meeting but has since gone on a conservative talk radio show to defend himself (DMN archive link) but his story has already started to shift: now he says he talked to the student’s mother about locker rooms.

Lowe won his seat from incumbent Kathy Hebert by 51 votes after a recount. His candidate website is bare-bones but mentions his opposition to CRT in the schools. Here’s some coverage of the race and Lowe’s supporters in Texas Monthly from last May, which demonstrates how Lowe’s candidacy is part of the ongoing reactionary attack on public schools, teachers, and curriculums in north Texas.

I don’t expect Lowe will resign, or be forced to, but I don’t expect we’ve heard the last of this case, or Lowe.

In other news: