Plan B is Over the Counter, why not Plan A?

The work to move birth control over the counter must be done in parallel to the work advocating for legal abortion. Both are equally important, and neither negates the other.

On July 11, France-based HRA Pharma submitted their Prescription-to-Nonprescription (Rx to OTC) Switch Application to the FDA, hoping to be the first providers of an over-the-counter oral birth control in the United States. The drug is currently on the market as OpillTM and requires a prescription, whereas the company’s UK version, under the name Hana, is available without a doctor’s order. 

OpillTM is a progesterone only pill or “minipill”, rather than a combination of progesterone and estrogen. The active ingredient is a synthetic progesterone called norgestrel, which works to prevent pregnancy by preventing ovulation and thickening the cervical mucus. During the normal menstrual cycle, fluctuations in estrogen and progesterone signal to the body that it should either prepare for a pregnancy or reset the cycle. 

These hormones communicate through a negative feedback system with other parts of the body, including the brain. This system is called the Hypothalamic-Pituitary-Gonadal (HPG) Axis.. In this process, the hypothalamus signals to the pituitary, which in turn communicates to the gonads (in this case, the ovaries), which produce estrogen and progesterone. When the body senses these hormones, it signals back to the hypothalamus  to stop signaling the pituitary, hence the name negative feedback. 

By adding exogenous (“outside the body”) progesterone, the feedback loop that exists between the brain and the reproductive system senses the presence of progesterone and downregulates the actions of the hypothalamus. In doing so, it also downregulates another important hormone called luteinizing hormone (LH), which is responsible for ovulation and ovulation is blocked.

Oral birth control has been around for over sixty years, and progesterone only pills are safe for the majority of reproductive-aged patients, including those who should not take the combination, estrogen-containing pill. This may give HRA Pharma an advantage in the approval of their application, which is expected to be under review for the next ten months.

HRA Pharma’s application followed on the heels of the Supreme Court’s June 24th ruling in Dobbs v. Jackson that overturned federal protection of abortion. With abortion now restricted or banned in many states, the potential for over-the-counter birth control is certainly invigorating news in the push for reproductive justice. However, improving birth control access will not negate the need for comprehensive, safe, and informed sexual healthcare, including abortion. 

The pill’s 91% efficacy in real world use is great. But what about the  9% of people who have a birth control failure? The work to move birth control over the counter must be done in parallel to the work advocating for legal abortion. Both are equally important, and neither negates the other. As one of my previous professors said, “As long as people are having sex, we will need abortions.”

That being said, moving OpillTM and other pills over-the-counter is an important step in achieving accessible, equitable health care. Eliminating barriers to using the birth control pill will empower people to control their own fertility. Historically, contraception, and the pill specifically, has been used to suppress vulnerable populations. Shifting oral contraceptives over-the-counter can alleviate hesitation in seeking a prescription and having to juggle a provider’s prejudice. It also reduces barriers such as taking time off work or finding alternative family care arrangements that are necessary when making an appointment at a physician’s office.

There is so much to benefit from OpillTM potentially coming onto pharmacy shelves, and we hope that HRA Pharma’s data, collected with help from Ibis Reproductive Health and others in the Free the Pill Coalition, will be enough to prove the safety and efficacy to the FDA. 

How We Got Here: The 2021-22 Supreme Court Hearings in Texas and Mississippi Abortion Cases

Before we begin posting about the science and technology aspects of abortion, we thought we would go over the recent history.

On Monday night, Politico published a leaked draft of the majority opinion in the Supreme Court calling to overturn Roe v. Wade.1 If the opinion becomes finalized this summer, it will end the forty-nine-year precedent of federal abortion protection and an individual’s right to choose.  Before we begin posting about the science and technology aspects of abortion, we thought we would go over the recent history.

The year 2021 saw a historic peak in legislation surrounding abortion in the United States, with 108 restrictions passed by the end of the year.2 One such restriction that raised concern was Texas Senate Bill 8 (SB8), brought to the Supreme Court on November 1 as United States v. Texas. The Supreme Court heard a second major lawsuit against Mississippi’s 15-week abortion ban on December 1, Dobbs v. Jackson, culminating in this latest draft opinion, the authenticity of which was confirmed by the Supreme Court on Tuesday.3 In light of both lawsuits, I will summarize the differences between the Texas and Mississippi cases and the implications the leaked, unfinalized opinion holds for Roe v. Wade.

First, it is important to understand some of the terminology commonly used in these cases. Abortion laws target different developmental milestones during the gestational period, as a major point of contention between pro-choice and anti-choice advocates is, “When does life begin?”

In general, fetal viability refers to the period between 22 and 24 weeks of pregnancy. This was determined as the point at which a fetus can survive outside of the womb, as approximately 50% of premature babies can live past this stage in development.4,5 This occurs during the second trimester and is used in twenty states as the point until which elective abortion is legal.6,7

Last September, Texas enacted a type of legislation termed a “heartbeat bill,” restricting abortion to the first six weeks of pregnancy since this is when a fetal heartbeat can first be detected. However, this developmental marker is debated within the scientific community.

In 2018, Mississippi introduced a bill banning abortion after the first trimester (15 weeks), claiming that dilation and evacuation, a surgical abortion procedure, is more dangerous than giving birth after this point.8 However, UCSF Health cites surgical abortion risks during the second trimester as having fewer and less serious risks than birth,9 and many studies have proven that legal abortion is safer than live birth.10–12 Furthermore, the Turnaway Study showed that individuals who sought abortions but were denied care were more likely to face physical, mental, and economic challenges in the future, with ramifications for all children in the family as well.12–14

So, What Is Texas Senate Bill 8 (SB8)?

What does the bill state?

The bill bans abortion after approximately six weeks and incentivizes civilians to sue anyone involved in providing or aiding an abortion after that period. Plaintiffs will receive at least $10,000, paid by the defendant, if successful in the lawsuit. While patients themselves cannot be sued, anyone who drove them to the hospital, funded, or performed the procedure falls under the law. Additionally, doctors who are sued must report the lawsuit(s) when reapplying for their medical licenses.15

How does this contribute to other restrictions in Texas?

Even before SB8, Texas already had many other abortion restrictions. The addition of Senate Bill 8 will increase driving distances to access abortion clinics fourteen-fold, as calculated by the Guttmacher Institute.16 Additionally, Texas is one of thirteen states that have passed “trigger bans,” which will automatically go into effect banning all, or almost all, abortion if Roe v. Wade is overturned.17,18

What did the Supreme Court decide?

On December 10, the Supreme Court released their 8-1 decision, allowing the Center for Reproductive Rights, a pro-choice organization, to continue their case against SB8 in the lower courts. As the Supreme Court did not move to block the bill itself, it will remain in effect unless overturned by the U.S. District Court.19  In the wake of this decision, many other states, including Oklahoma, Arizona, and South Dakota, began to produce copycat bills of SB8, seeking to limit abortion access to six weeks of pregnancy or less in anticipation of Roe v. Wade being overturned this summer.

How Does this Relate to Mississippi’s House Bill 1510 (Gestational Age Act)?

Although many abortion restrictions have been said to contradict Roe v. Wade, the Gestational Age Act poses the biggest threat to overturning the 1973 landmark case. When the state petitioned to have Dobbs v. Jackson heard by the Supreme Court, they emphasized that the case was only about the legality of the 15-week ban, but during the hearing on December 1, the state centered their argument on the need to overturn Roe v. Wade. Chief Justice Roberts termed this tactic “bait and switch.”20

If the outcome of Dobbs v. Jackson is to overturn Roe v. Wade, Texas, Mississippi, and many other states will move to completely ban, or to severely limit, abortion services. Oklahoma, for example, has passed SB612, which criminalizes abortion as a felony except when the pregnant individual’s life is in jeopardy; the bill is set to go into effect on August 26.21 Not only will the removal of Roe v. Wade inhibit bodily autonomy, but it will likely have a disproportionate impact on those who do not have the financial resources to travel out of state. 

While those who seek abortion represent a range of reproductive ages, classes, races, gender identities, and family dynamics, most are living in poverty, in their twenties, and already have at least one child.22,23 Clearly, increasing abortion restrictions would make it more difficult, if not impossible, to get care for those already burdened by social determinants like inconsistent access to transportation, lack of childcare services, and inability to take time off work and lose pay.

Furthermore, the comparative risk of live childbirth is more severe in Black individuals, who have up to a 450% higher risk of death than white individuals.24–27 This will cause devastating consequences if states enact stricter abortion limitations or bans, forcing higher numbers of unwanted pregnancies to be carried to term despite the enormous risk of death in doing so.

The apparent end of Roe v. Wade is quickly approaching, and it is a catastrophic loss for reproductive rights in this country. However, with midterm elections occurring this year, it reemphasizes now, more than ever, why every vote matters, especially to support pro-choice candidates at the local, state, and congressional levels. Furthermore, Abortion Finder, Planned Parenthood, and other pro-choice organizations are continuing their fight to support individuals looking to end their pregnancies,28–30 and the National Network of Abortion Funds is managing donations that will support travel and associated expenses for those who must go out of state to seek care.31 Large businesses must also consider including abortion aid in employee benefits, as Yelp, Citigroup, Match Group, and others have done.32

References

1.        Supreme Court has voted to overturn abortion rights, draft opinion shows – POLITICO. https://www.politico.com/news/2022/05/02/supreme-court-abortion-draft-opinion-00029473.

2.        State Policy Trends 2021: The Worst Year for Abortion Rights in Almost Half a Century | Guttmacher Institute. https://www.guttmacher.org/article/2021/12/state-policy-trends-2021-worst-year-abortion-rights-almost-half-century.

3.        Supreme Court Live Updates: Roe v. Wade Draft Decision Leaked – The New York Times. https://www.nytimes.com/live/2022/05/03/us/roe-wade-abortion-supreme-court?emc=edit_na_20220503&ref=cta&nl=breaking-news.

4.        When Is It Safe to Deliver Your Baby? | University of Utah Health. https://healthcare.utah.edu/womenshealth/pregnancy-birth/preterm-birth/when-is-it-safe-to-deliver.php.

5.        Periviable Birth | ACOG. https://www.acog.org/clinical/clinical-guidance/obstetric-care-consensus/articles/2017/10/periviable-birth.

6.        States with Gestational Limits for Abortion | KFF. https://www.kff.org/womens-health-policy/state-indicator/gestational-limit-abortions/?currentTimeframe=0&sortModel=%7B%22colId%22:%22Location%22,%22sort%22:%22asc%22%7D.

7.        State Bans on Abortion Throughout Pregnancy | Guttmacher Institute. https://www.guttmacher.org/state-policy/explore/state-policies-later-abortions.

8.        Bill Text: MS HB1510 | 2018 | Regular Session | Enrolled | LegiScan. https://legiscan.com/MS/text/HB1510/id/1758892.

9.        Surgical Abortion (Second Trimester) | Conditions & Treatments | UCSF Health. https://www.ucsfhealth.org/treatments/surgical-abortion-second-trimester.

10.      Raymond, E. G. & Grimes, D. A. The comparative safety of legal induced abortion and childbirth in the united states. Obstetrics and Gynecology 119, 215–219 (2012).

11.      Darney, B. G. et al. Quality of care and abortion: beyond safety. BMJ Sexual & Reproductive Health 44, 159–160 (2018).

12.      Gerdts, C., Dobkin, L., Foster, D. G. & Schwarz, E. B. Side Effects, Physical Health Consequences, and Mortality Associated with Abortion and Birth after an Unwanted Pregnancy. Women’s Health Issues 26, 55–59 (2016).

13.      The Turnaway Study | ANSIRH. https://www.ansirh.org/research/ongoing/turnaway-study.

14.      The Harms of Denying a Woman a Wanted Abortion Findings from the Turnaway Study.

15.      Bill Text: TX SB8 | 2021-2022 | 87th Legislature | Enrolled | LegiScan. https://legiscan.com/TX/text/SB8/id/2395961.

16.      Impact of Texas’ Abortion Ban: A 14-Fold Increase in Driving Distance to Get an Abortion | Guttmacher Institute. https://www.guttmacher.org/article/2021/08/impact-texas-abortion-ban-14-fold-increase-driving-distance-get-abortion.

17.      Texas abortion access on the line as Supreme Court reconsiders Roe v. Wade | The Texas Tribune. https://www.texastribune.org/2021/11/30/texas-mississippi-abortion-supreme-court/.

18.      Abortion Policy in the Absence of Roe | Guttmacher Institute. https://www.guttmacher.org/state-policy/explore/abortion-policy-absence-roe.

19.      Supreme Court of the United States. Whole Woman’s Health Et Al. v. Jackson, Judge, District Court of Texas, 114th District, Et Al. (2021).

20.      What Happened at the Supreme Court Arguments Over the Mississippi Abortion Law – The New York Times. https://www.nytimes.com/live/2021/12/01/us/abortion-mississippi-supreme-court?auth=login-google&campaign_id=60&emc=edit_na_20211201&instance_id=0&nl=breaking-news&ref=cta&regi_id=131053017&segment_id=75757&user_id=ff175822554a8549ff416a9485e3de94.

21.      Oklahoma Lawmakers Approve Near-Total Ban on Abortion – The New York Times. https://www.nytimes.com/2022/04/06/us/oklahoma-abortion-ban.html.

22.      Demographics | Guttmacher Institute. https://www.guttmacher.org/united-states/abortion/demographics.

23.      Induced Abortion in the United States | Guttmacher Institute. https://www.guttmacher.org/fact-sheet/induced-abortion-united-states.

24.      Texas’s New Abortion Law Will Harm People of Color, Further Entrench Racist Policies | Commonwealth Fund. https://www.commonwealthfund.org/blog/2021/texass-new-abortion-law-will-harm-people-color-further-entrench-racist-policies.

25.      Racial and Ethnic Disparities Continue in Pregnancy-Related Deaths | CDC Online Newsroom | CDC. https://www.cdc.gov/media/releases/2019/p0905-racial-ethnic-disparities-pregnancy-deaths.html.

26.      Black Women Over Three Times More Likely to Die in Pregnancy, Postpartum Than White Women, New Research Finds | PRB. https://www.prb.org/resources/black-women-over-three-times-more-likely-to-die-in-pregnancy-postpartum-than-white-women-new-research-finds/.

27.      Hoyert, D. L. Maternal Mortality Rates in the United States, 2019. (2019) doi:10.15620/cdc:103855.

28.      I need an abortion. https://www.ineedana.com/.

29.      Where Can I Get an Abortion? | U.S. Abortion Clinic Locator. https://www.abortionfinder.org/abortion-guides-by-state.

30.      Planned Parenthood on Supreme Court Leak: Our Worst Fears Confirmed, Supreme Court Appears Poised to Overturn Roe . https://www.plannedparenthood.org/about-us/newsroom/press-releases/planned-parenthood-on-supreme-court-leak-our-worst-fears-confirmed-supreme-court-appears-poised-to-overturn-roe.

31.      Home – National Network of Abortion Funds. https://abortionfunds.org/.

32.      Yelp joins growing list of companies offering workers help with abortion care – CNN. https://www.cnn.com/2022/04/12/business/companies-abortion-care/index.html.