Now Is the Time to Change Label on Emergency Contraceptives
Research supports change
June 1, 2022 4 minutes read
EXECUTIVE SUMMARY
Plan B, the levonorgestrel-based emergency contraception, only prevents ovulation, but has no action after ovulation, meaning that it does not stop implantation or a pregnancy, research confirmed.
- Anti-abortion groups and individuals have treated Plan B as an abortifacient, with some declining to pay for the drug through health plans, such as in the Hobby Lobby case.
- This misinformation would stop if the Food and Drug Administration (FDA) changed the drug’s labeling to remove the wording that says it may inhibit implantation.
- The FDA’s inaction could lead to states banning Plan B in a post-Roe era.
The Food and Drug Administration (FDA) should change the labeling for levonorgestrel-based emergency contraception to reflect evidence-based knowledge that the drug does not act as an abortifacient, according to researchers.1,2
The label change is especially important now, as states are banning abortions and sometimes defining it in ways that would prohibit pharmacies from selling emergency contraception under its current FDA labeling.
“A lot of anti-abortionists consider abortion to be any interference with the fertilized embryo, anything that prevents implantation,” says Chris ChoGlueck, PhD, assistant professor of ethics in the department of communication, liberal arts, and social sciences and faculty advisor for responsible conduct of research at New Mexico Tech. ChoGlueck is the author of a recent commentary on the topic.1
Plan B Prevents Ovulation
Levonorgestrel-based emergency contraception inhibits ovulation to prevent fertilization. “The mainstream obstetrics/gynecologist’s definition is that abortion is not preventing implantation, but acting after implantation,” ChoGlueck adds. “Regardless of the definition that you choose in this case, there’s really no reason to think Plan B acts any other way than preventing ovulation. It’s not effective if you give it after ovulation or fertilization, and there are extensive studies on this.”
A new research review shows that taking the medication after ovulation does not affect implantation and results in similar conception rates when compared to placebo. It also does not interfere with fetal development, nor does it cause miscarriage, stillbirth, and subsequent menstruations.2
“The conflation of Plan B with abortion is a continued threat to access to emergency contraception,” ChoGlueck says.
For example, in the U.S. Supreme Court decision in Burwell v. Hobby Lobby Stores, the court sided with Hobby Lobby and co-plaintiffs, Conestoga Wood Specialties Corp. and Mardel stores, saying the for-profit corporation’s owners held sincere Christian beliefs that life begins at conception, and it would violate their religion to facilitate access to contraceptive drugs or devices that operate after that point. Hobby Lobby wanted to resist coverage for IUDs and emergency contraception, despite research showing that neither contraceptive operates after conception.3
“This is another reason I argue we should get rid of this label,” ChoGlueck says. “[The label is] not helping people make decisions, and it’s a way of empowering providers to refuse to provide the drug.”
For instance, several states permit pharmacists to refuse to provide medications to which they have explicit objections. The current Plan B labeling gives them an excuse to exclude emergency contraception from their shelves.
ChoGlueck notes that the FDA labeling was influenced by politics in the early 2000s. “In meetings in 2003 and 2004, the advisory committee for reproductive health argued it was important to get this label because you need to provide informed consent for patients, and some want to avoid abortion,” he says. “The label says it might have this effect, and we don’t believe it does have this effect.”
Also, the drug’s sponsors have not advocated for a label change — even as more studies show the labeling is inaccurate.
“In the review process, and in my conversations with some of the people who were formerly with the FDA, the drug sponsors who had patent rights [to levonorgestrel-based emergency contraception] didn’t do enough and continue to not do enough to combat misinformation about Plan B,” ChoGlueck explains. “What I’m arguing is the drug companies are unlikely to do this because there are other issues with Plan B’s label that they haven’t moved on, like how efficacy could be contingent on BMI [body mass index]. But that’s important information for users as well.”
Although research shows the drug does not affect implantation, the FDA-approved label says it may inhibit implantation. That is what should change, ChoGlueck says.
The label for levonorgestrel-based emergency contraception reads, “Mechanism of Action: Emergency contraceptive pills are not effective if a woman is already pregnant. Plan B One-Step is believed to act as an emergency contraceptive principally by preventing ovulation or fertilization (by altering tubal transport of sperm and/or ova). In addition, it may inhibit implantation (by altering the endometrium). It is not effective once the process of implantation has begun.”4
There could be a shift toward attacking contraceptives among conservative lawmakers, starting with Plan B. “They’re easy to go after,” ChoGlueck adds. “Also, a lot of states have these conscientious objector laws or religious freedom laws, which often are pretty vague, that say if you have a moral objection to this, you don’t have to provide it to anybody, and you get to decide what is wrong.”
It is critically important to maintain Plan B access in states that ban abortion. Emergency contraception can prevent pregnancy when couples have unprotected sex, or when condoms break.
“Plan B is an important part of the contraceptive toolkit, especially with the changes in abortion laws,” ChoGlueck says. “The really scary thing is that, in some ways, Plan B will be the last legal line of defense.”
REFERENCES
- ChoGlueck C. The FDA ought to change Plan B’s label. Contraception 2022;106:6-9.
- Endler M, Li R, Danielsson KG. Effect of levonorgestrel emergency contraception on implantation and fertility: A review. Contraception 2022;109:8-18.
- Supreme Court of the United States. Burwell, Secretary of Health and Human Services et. al. v. Hobby Lobby Stores, Inc., et. al. Decided June 30, 2014.
- Food and Drug Administration. Highlights of prescribing information (Plan B). Revised July 2009.
You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
- Award-winning Medical Content
- Latest Advances & Development in Medicine
- Unbiased Content