In a bold and dangerous move, Attorneys General in 21 states are trying to get the Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) to remove protections from women who are seeking the abortion pill. Needless to say, this puts women across the country at risk and could be an unnecessary burden on the already stressed hospital system.
Every drug that is approved by the FDA must go through a screening process. If the drug is at risk for certain serious complications, then a Risk Evaluation and Mitigation Strategy (REMS) must be created and enforced for the public’s protection. According to the FDA’s website, “REMS is a drug safety program that the U.S. FDA can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risk. … While all medications have labeling that informs health care stakeholders about medication risks, only a few medications require a REMS.”
Just to put this into context, there are “20,000 different prescription drug products that the FDA has approved for marketing,” but only 58 have a REMS. Some of the drugs that have REMS include sodium oxybate, which is used to treat narcolepsy but is also known as GHB or the date-rape drug. It’s not even available at retail pharmacies. There’s also Dsuvia, a pain medication that was the subject of immense criticism upon its approval, with Raeford Brown, MD, chair of the FDA’s Anesthetic and Analgesic Drug Products Committee, arguing that the opioid would quickly “encounter diversion, abuse, and death within the early months of its availability on the market.”
Drugs get REMS for a reason, and there is a reason that there is a REMS for the abortion pill Mifepristone. The medical/chemical abortion process, also known as the abortion pill, is complicated. It begins with women taking Mifepristone to end the pregnancy, though it is not 100% effective. After the Mifepristone is given, usually in the abortionists’ office, the women go home and take misoprostol, a drug that is only FDA approved to reduce the risk of stomach ulcers. This drug then causes the uterus to contract, which, in theory, produces an unnatural miscarriage.
It’s a complex process, which is fraught with potential complications. Most women experience immense pain, bleeding, nausea, vomiting, diarrhea, chills and fever, which at times can be extreme. Serious complications include hemorrhaging, infection/sepsis, undiagnosed ectopic pregnancy (a potentially fatal complication), incomplete abortion requiring a follow up surgical abortion, uterus rupture and, in rare instances, death.
The idea that attorneys general, who are not doctors, would argue to lessen these restrictions are doing a disservice to the women they are sworn to support.
As argued in the letter to the FDA and HHS, these attorney generals argue that “REMS create unnecessary barriers between women and abortion care, not only making it harder to find—for example, by prohibiting sale by retail or mail-order pharmacies—but also making it unappealing to prescribe.” They even have the audacity to say in the letter that “Mifepristone is fourteen times safer than carrying a pregnancy to term.”
If abortion is safer than a pregnancy, why should any woman have a child then?
This letter is both ridiculous and irresponsible, especially from the people that would do anything to protect abortion. The REMS is in place to protect women and families from potentially serious or even fatal complications. Due to the political nature surrounding abortion, few detailed and complex studies have ever been completed to try and really understand the effects of the drug. One study that is often cited about the supposed “safety” of the abortion drug was run by a combination of abortionists and the drug maker. It’s not difficult to imagine that the study found absolutely no fault with the abortion pill.
There’s also the question of whether women getting the abortion pill through telemedicine, as suggested by the attorney generals, know how far along they really are in their pregnancy, recognize the symptoms of an ectopic pregnancy or are in the right state of mind to have an abortion, all things that should be discovered in a proper medical office visit.
The FDA and HHS should remain firm. Once these organizations loosen the REMS on Mifepristone, it will be difficult if not impossible to get restrictions back into place. As a nation, we should focus on keeping people healthy, not releasing a dangerous drug without proper medical supervision to support a political agenda.