In September 2000, the U.S. Food and Drug Administration (FDA) approved the abortion pill mifepristone for sale. This approval was contingent on the use of another drug, misoprostol, in accordance with a specified protocol. Mifepristone was administered on the first day to block the pregnancy hormone progesterone and to essentially starve the baby to death. Subsequently, a day or so later, women were to take the prostaglandin misoprostol to stimulate powerful contractions to expel the dying or dead child.
Approval for the use of misoprostol was granted by the FDA a decade prior to its use in the abortion process. Its initial approval was for the treatment of gastric ulcers in individuals taking non-steroidal anti-inflammatory drugs (NSAIDs). Due to its impact on the uterus, misoprostol has consistently been accompanied by the FDA’s “black box warning” on its official label, cautioning pregnant women that the use of the drug may pose a threat to their pregnancies.
The medication was inexpensive and widely available, which led physicians and other healthcare professionals who were aware of its abortifacient properties and had access to the drugs to prescribe or sell them to women seeking to terminate their pregnancies. This was particularly prevalent in countries where abortion was not legal or mifepristone was not available.
In light of the recent legal developments surrounding abortion in the United States, many within the abortion industry are considering alternative methods of abortion. This is due to the fact that abortion is currently illegal in some U.S. states, and a lawsuit is currently being heard in the federal court system, which could result in the withdrawal of approval for mifepristone as an abortifacient or otherwise limit the availability of the abortion pill. Consequently, many within the abortion industry are exploring the use of misoprostol as a potential solution.
Some have already taken this step. Carafem, a high-end abortion chain with four brick-and-mortar locations (Chicago, Washington, D.C., Atlanta, Nashville) and a thriving online abortion business, began offering misoprostol-only abortions as an option in 2020. Carafem reported that 80% of its patients opted for misoprostol alone when the Supreme Court temporarily reinstated the requirement that patients collect mifepristone in person at the clinic following the FDA’s suspension of this requirement during the pandemic. During this period, Carafem sent the misoprostol when it was not permitted to do so with mifepristone (Slate, 13 February 2023).
In recent days, governors in California and New York have both announced plans to stockpile misoprostol in the event of an interruption in the supply of mifepristone. New York Governor Kathy Hochul has indicated that her state is planning to purchase a five-year supply of the drug, while California Governor Gavin Newsom has stated that they intend to procure up to 2 million pills of the medication.
A brief overview of the available information on the use of misoprostol alone for abortion is provided below.
The efficacy of misoprostol as an abortifacient is a topic of ongoing debate. One must also consider the question of safety.
It is, of course, illogical and a misuse of language to describe any pill that kills human beings on a regular and intentional basis as “safe.” However, if the question is whether misoprostol is an effective method of inducing an abortion without causing maternal mortality or permanent physical injury, the answer is affirmative. According to Ngoc (2011) and E. Raymond (2019), the success rate of complete abortion with misoprostol is between 76 and 78 percent, with minimal maternal mortality and no cases of permanent physical injury.
This renders misoprostol considerably less efficacious than the 93-97% efficacy rate claimed for the mifepristone-misoprostol combination. Nevertheless, it remains efficacious enough for an abortion industry seeking a cost-effective alternative where mifepristone supply is limited.
It should be noted that these abortions are not without risk, discomfort, or ease. While the use of misoprostol may result in longer-lasting painful cramps and bleeding, these symptoms are still a common occurrence in women undergoing this procedure. Furthermore, patients who use misoprostol to induce abortion are also likely to experience more nausea, vomiting, and diarrhoea. There is a greater likelihood of failure or incomplete abortion.
It is well documented that these side effects have resulted in hospitalisation of some women. It is important to note that chemical abortions are never easy or comfortable, and the use of misoprostol alone may result in a less comfortable experience.
The question of the legality of misoprostol abortions is a pertinent one.
As previously stated, the FDA granted approval for misoprostol (under the trade name Cytotec) in 1988 as an anti-ulcer drug for patients who consume a substantial amount of non-steroidal anti-inflammatory drugs (NSAIDs). This is the sole indication for which this drug has been approved by the FDA.
Once a drug has received FDA approval, it is available for sale on the market. Any licensed physician is then permitted to prescribe the medication for any purpose or application that they deem appropriate. It is therefore possible, and indeed has been the case, that some abortionists have legally prescribed this medication for this lethal purpose.
However, this does not necessarily imply that the prescriber can evade legal or financial ramifications.
The prescription of a pharmaceutical agent outside the parameters for which it has been approved carries the risk of legal action should the patient experience adverse effects, including failure of the drug or the onset of serious complications. This is particularly pertinent in the case of abortion, where the abortionist does not have the backing of the FDA in terms of the drug’s safety or efficacy for that specific use.
Furthermore, state or federal laws that protect unborn children or otherwise prohibit chemical abortions would also make the prescription or mailing of misoprostol for this purpose illegal. In such a scenario, a physician would be unable to legally dispense misoprostol for the purpose of abortion, and a pharmacy receiving a prescription specifying its use for this purpose would be similarly prohibited from filling it.
It would be beneficial to ascertain whether misoprostol abortions are more affordable and accessible than other forms of abortion.
The cost of misoprostol, which is available at a price below one dollar per pill, is considerably less than that of mifepristone. According to GoodRx, the generic version of mifepristone can be purchased at an average retail price of just over $83 per pill.
Given its long-standing availability on the market and regular stocking in pharmacies, misoprostol is more familiar and more widely available than mifepristone, even in states or countries where the latter is not legally permitted or publicly sold.
Those who advocate for abortion are aware of this and have advised women and medical professionals on how to exploit potential weaknesses in the system. They propose that pregnant women seeking chemical abortions find doctors to prescribe them medication to treat their “ulcers.” They recommend that these women attempt to persuade pharmacists to provide them with a few pills for “a visiting aunt who forgot her prescription.” They instruct women on how to order these pills online or simply advise them to procure these misoprostol pills from the illicit market.
What measures could be taken to prevent the utilisation of misoprostol for the termination of pregnancy?
The official approval of misoprostol is limited to its use as an anti-ulcer drug, rather than as a standalone abortifacient. Consequently, there is no justification for the FDA to revoke this approval and remove the drug from the market.
Nevertheless, this does not imply that no action can be taken.
In states where abortion is legal, doctors may prescribe these drugs off-label for abortion, regardless of the availability of mifepristone (due to unresolved legal issues currently being considered by the courts). However, those who do so could be held legally liable if something goes wrong and the woman suffers injury, since the prescriber lacks the FDA’s authorisation for this use.
The prospect of litigation may act as a deterrent for those contemplating the prescription of misoprostol for abortion.
In addition, states that have enacted legislation providing comprehensive protection for unborn children or that have enacted general prohibitions on the prescription, sale, or use of chemical abortifacients would also be granted the authority to prosecute those who prescribe mifepristone, misoprostol, or any other drug with the intention of inducing an abortion. The NRLC does not support any legislation that would result in the prosecution of women who use these pills.
It should be noted that the use or prescription of any of these medications for legitimate (non-abortifacient) medical purposes would continue to be permitted. However, should evidence emerge that misoprostol or any other drugs were being prescribed with the intention of chemically inducing abortion, this would, at the very least, prompt an investigation and give pharmacies reason to deny filling these prescriptions.
In light of the aforementioned circumstances, it may be beneficial for states to enact legislation or regulations requiring that prescribers indicate the intended purpose for the drugs on their prescription forms. This would oblige physicians to officially declare their intentions, thereby either admitting the true abortifacient intent of their prescription or risking criminal liability for falsifying their orders.
It is unlikely that these measures would definitively prevent the misuse of these drugs for lethal purposes. However, they could potentially dissuade abortionists from issuing prescriptions for these drugs.
It should be noted that misoprostol was included in the FDA-approved protocol for mifepristone in 2000. However, the FDA did not make any changes to misoprostol’s own label reflecting this inclusion.
Daniel Miller is responsible for nearly all of National Right to Life News' political writing.
With the election of Donald Trump to the U.S. presidency, Daniel Miller developed a deep obsession with U.S. politics that has never let go of the political scientist. Whether it's the election of Joe Biden, the midterm elections in Congress, the abortion rights debate in the Supreme Court or the mudslinging in the primaries - Daniel Miller is happy to stay up late for you.
Daniel was born and raised in New York. After living in China, working for a news agency and another stint at a major news network, he now lives in Arizona with his two daughters.
