Women’s Healthcare: Will Changing Laws Inhibit Latest Innovations in Fertility and Birth Control Treatments?

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On June 17, 2022, the Supreme Court overturned Roe v. Wade in a 6-3 decision, effectively ending decades of guaranteed access to abortions in numerous states.¹ In the time since, there have been a growing number of legal battles aimed at restricting access to abortion and fertility treatments throughout the United States. Earlier this year, the Alabama Supreme Court declared that under state law, embryos were considered to be children, ending all fertility treatments being conducted in the state as a result. While Senate Republicans have introduced legislation aimed at protecting in vitro fertilization (IVF), Democrats disagreed, offering their own plan for IVF treatments.²

“The states have a series of legislation pending from limiting access to guaranteeing access to IVF, so it’s all over the place,” said Ron Lanton, partner, Lanton Law. “Where we are in the calendar right now, a lot of states have adjourned, but there are some states that are year-round, so we’ll see what they do in January. But I think this is something that is definitely going to come back in the next session.”

Last month, the Supreme Court struck down a challenge to the FDA’s regulation of mifepristone in a unanimous decision, citing that the plaintiffs were unregulated parties that neither prescribed nor have taken the treatment. The plaintiffs, which consisted of a group of physicians, alleged that the FDA stumbled on the regulation of mifepristone in 2016 and 2021.³

“The FDA recklessly leaves women and girls to take these high-risk drugs all alone in their homes or dorm rooms, without requiring the ongoing, in-person care of a doctor,” said Erin Hawley, attorney for the Alliance Defending Freedom (ADF), according to the Wisconsin Examiner. Additionally, Hawley stated that the ADF was grateful to attorneys general in Idaho, Kansas and Missouri who intervened in the case at the district court level, citing intentions to keep fighting litigation.⁴

Despite Danco Laboratories, the maker of mifepristone, considering the ruling a win for the pharmaceutical industry, challenges are still being brought by the states of Missouri, Kansas, and Idaho.³

“Depending on how judges interpret current law and legislation in their specific jurisdictions, anything can happen,” Lanton said. “What the Supreme Court did was dismiss the case for lack of standing, stating that the doctors were not the proper guys to bring the lawsuit. This means that any other parties in the future that do have standing may get a decision that bans the drug in the lower courts. Unfortunately, what will happen is this process will start all over again. That means that it could take years to get back to the Supreme Court and with everything that’s been happening recently, it’s just not clear on how they will rule.”

Since the overturning of Roe v. Wade, 21 states have either banned or restricted access to abortion, with temporary blocks currently being enforced in Montana and Wyoming, while Iowa is expecting to enforce a six-week ban despite a lawsuit proceeding against it. Twenty-seven other states allow abortion in one form or another, such as emergency access.⁵

“The Supreme Court didn’t answer the question of emergency access to abortion in Idaho vs. the United States,” continued Lanton. “Now the issue will continue in the lower courts, which is going to create different rulings regarding the interpretation of the Emergency Treatment and Active Labor Act, which requires hospitals to provide stabilizing care for those in an emergency medical condition. Most doctors and healthcare workers have determined that the Supreme Court hasn’t given any help in regard to whether they would face prosecution for an emergency abortion in these states that have banned that procedure.

“This means that some emergency rules may continue in the immediate future as they have been doing; waiting until the last possible moment and sending pregnant people back home to wait for their health to get worse, which is horrible to even think about. Because of the law being what it is, it’s created this situation and people are scared in an ambiguous situation where there really should be clarity.”

Last month, Senate Republicans blocked legislation that would guarantee access to contraception in the United States, citing it as a partisan stunt by the Democrats due to contraception already being legal.⁶

“This is a show vote. It’s not serious. It doesn’t mean anything. And, plus, it’s a huge overreach. It doesn’t make any exceptions for conscience, it creates mandates,” said Sen. John Cornyn (R-Texas) according to NBC News. “It’s a phony vote because contraception, to my knowledge, is not illegal.”

However, Democrats suggested that the bill was necessary, stating that the Supreme Court couldn’t be trusted to protect the use of contraceptives under the 1965 case Griswold v. Connecticut. Additionally, they cited the overturning of Roe v. Wade as well as Justice Clarence Thomas previously stating that the court should reconsider precedents such as Griswold.⁶

“We saw what the Supreme Court did on abortion, and now there’s a real risk they may do the same thing on contraception,” said Sen. Elizabeth Warren (D-Mass) in an interview with MSNBC.

The legislative impasse comes at a time in which a number of innovative treatments in women’s health are advancing. Last September, the FDA cleared Femaseed, a technology developed by Femasys to support infertility. According to the company, the treatment is less invasive and more affordable than assisted reproduction procedures, such as IVF.⁵ Earlier this month, PharmExec sat down with Kathy Lee-Sepsick, founder and CEO of Femysys, to discuss Femaseed, the importance of women’s health access, and the company’s FemBloc, a permanent birth control.⁷

“Femaseed was purposely designed to enhance the normal transport of sperm that's required in order for conception to occur. We place sperm directly into the fallopian tube that is the site of fertilization,” Lee-Sepsick told PharmExec. “Our technology purposely positions balloon technology at the opening of the tube, so it's a much safer way to deliver it to the tube. The goal is to enhance something that's naturally going to occur, so we eliminate the production of embryos or retrieval of eggs. None of that occurs with our technology. It's simply placement of the sperm directly in the fallopian tube. As far as enhancements, we've been developing this product for some time, and we have thoughtfully enhanced it along the development process.”⁸

With little certainty regarding the direction of Supreme Court rulings in the foreseeable future, clinical trials for Fembloc are currently in progress. Earlier this year, Femysys initiated enrollment in the pivotal trial (NCT05977751) at two new sites, resulting in a total of six active trial sites.⁹

“From a permanent birth control standpoint, there is only one option available to women around the world, and that's surgical tubal ligation,” said Lee-Sepsick. “When we come to that point in our lives, whether we're had enough children in our twenties or in our forties, or don't want to have any more children, the options are so limited.”¹⁰

According to the Institute for Women's Policy Research (IWPR), restrictions on women’s reproductive rights are directly linked to an annual cost of $173 billion in the United States. IWPR stated that these restrictions could lead to lower graduation rates, lower lifetime earnings, and poorer outcomes for children, which was highlighted in a Senate Budget Committee hearing this past February. IWPR also pointed out that in states where abortion is illegal, women tend to work more hours for lower wages and face earlier and more frequent childbirths. Further, the article argues that reproductive care is a fundamental part of healthcare.¹¹

Lee-Sepsick offered a positive outlook regarding the future of women’s reproductive rights.

“I've never seen this much discussion and spotlighting of women's health issues and concerns for wherever anyone stands on the issue,” she said. “I think most would agree that women deserve more options, and they need to be better. I don't think on either side there will be discordance around the fact that we need more options for women, and we need to support companies that are willing to undergo that task. It is a very difficult specialty to get funding. It's very difficult from a regulatory standpoint to advance technologies. The fact that it’s such a topic of conversation for a presidential election warms my heart from a feminist standpoint, because we've been for two decades trying to advance our technologies forward.”

References

1. In 6-to-3 Ruling, Supreme Court Ends Nearly 50 Years of Abortion Rights. NY Times. June 24, 2022. Accessed July 24, 2024. https://www.nytimes.com/2022/06/24/us/roe-wade-overturned-supreme-court.html

2. Americans want to protect IVF amid battles over abortion, but Senate at odds over path forward. CBS News. May 24, 2024. Accessed July 24, 2024. https://www.cbsnews.com/news/ivf-senate-at-odds-over-legislation/

3. Supreme Court unanimously strikes down legal challenge to abortion pill mifepristone. ABC News. June 13, 2024. Accessed July 24, 2024. https://abcnews.go.com/Politics/supreme-court-unanimously-strikes-legal-challenge-abortion-pill/story?id=110439079

4. Anti-abortion groups say Supreme Court’s mifepristone ruling won’t deter them. Wisconsin Examiner. June 17, 2024. Accessed July 26, 2024. https://wisconsinexaminer.com/2024/06/17/anti-abortion-groups-say-supreme-courts-mifepristone-ruling-wont-deter-them/

5. Tracking Abortion Bans Across the Country. NY Times. July 1, 2024. Accessed July 24, 2024. https://www.nytimes.com/interactive/2024/us/abortion-laws-roe-v-wade.html

6. Senate Republicans block bill to protect access to contraception. NBC News. June 5, 2024. Accessed July 24, 2024. https://www.nbcnews.com/politics/congress/senate-republicans-block-bill-protect-americans-access-contraception-rcna155448

7. Femasys Inc. Receives U.S. FDA Clearance to Market FemaSeed, an Innovative Infertility Treatment Solution. Yahoo!Finance. September 25, 2023. Accessed July 24, 2024. https://finance.yahoo.com/news/femasys-inc-receives-u-fda-212500126.html

8. Femasys Founder Discusses Femaseed Technology Designed to Support Infertility. Pharm Exec. July 5, 2024. Accessed July 24, 2024. https://www.pharmexec.com/view/femasys-founder-discusses-femaseed-technology-designed-support-infertility

9. Femasys Announces Financial Results for Quarter Ended March 31, 2024, and Provides Corporate Update. GlobeNewswire. May 9, 2024. Accessed July 24, 2024. https://www.globenewswire.com/news-release/2024/05/09/2878750/0/en/Femasys-Announces-Financial-Results-for-Quarter-Ended-March-31-2024-and-Provides-Corporate-Update.html

10. Femasys CEO Talks Results of the Femaseed Pivotal Trial and the History of Fembloc Birth Control. PharmExec. July 9, 2024. Accessed July 24, 2024. https://www.pharmexec.com/view/femasys-ceo-talks-results-femaseed-pivotal-trial-history-fembloc-birth-control

11. The Economic Fallout of Reproductive Rights Restrictions on Women’s Futures. IWPR. Accessed July 24, 2024. https://iwpr.org/the-economic-fallout-of-reproductive-rights-restrictions-on-womens-futures/