Why did the FDA lift its ban on sending abortion pills by mail?
- The FDA lifted its ban on mailing the drug mifepristone last week, expanding access to reproductive health care.
- Mifepristone, along with the drug misoprostol, was first approved by the FDA to terminate pregnancies up to 70 days in 2000; it has few side effects, experts say.
- Previously, patients had to collect these pills in person; now patients can be prescribed and sent in for the drugs via a telehealth visit.
Last week, the Food and Drug Administration (FDA) announcement it will permanently allow abortion pills to be mailed, lifting its previous requirement that patients withdraw drugs in person.
The decision is already expanding access to reproductive health care: now the drug mifepristone can be prescribed and sent directly to patients via a telehealth appointment. When taken with another medicine, misoprostol, within 10 weeks of gestation, it blocks a hormone necessary for pregnancy, causing the pregnancy to terminate early.
“The FDA is finally following the science,” explains Emily Godfrey, MD, MPH, a registered family physician and associate professor in the departments of family medicine and obstetrics and gynecology at the University of Washington. âMifepristone is a very important medicine not only for people who want to terminate their pregnancy, but also for those who want to manage a miscarriage. “
Experts know that mifepristone is largely safe and effective, and has over 20 years of data supporting its use, so why did the FDA only lift restrictions on the drug this month -this ? And does that mean everyone in the US can now access abortion pills by mail? Here’s what you need to know about the FDA’s new drug rules.
What is mifepristone and why has it been restricted?
Mifepristone, often sold under the brand name Mifeprex, is a drug that blocks the hormone progesterone, which is needed to maintain pregnancy, according to the FDA. It is only available to terminate early pregnancies, those that have been pregnant for 70 days or less. (This method is different from the morning after pill and clinic abortions.) Common side effects include vaginal cramps and bleeding.
The drug is administered at the same time misoprostol, another drug that dilates the cervix, triggers uterine contractions and expels tissue, according to the International Women’s Health Coalition. Although it can be used on its own, it is combined with mifepristone to induce medical abortion more effectively.
Although mifepristone has been approved by the FDA since 2000 and has a very low risk of complications, it is regulated by the agency as part of a ârisk assessment and mitigation strategyâ. Until last week, that strategy forced patients to go to a clinic or specialist hospital approved as a supplier of mifepristone by the manufacturer of the drug, and then sign a form acknowledging the purpose of the drug before receiving the pills.
âWhat’s so deep about the strict FDA regulations is the fact that the pill is so safe. It is probably one of the safest pills people can take, âsays Dr Godfrey. Because it only inhibits progesterone, it is highly targeted unlike, for example, chemotherapy or antibiotics, which can cause side effects while they work to help patients. However, women who need to take steroids every day should exercise caution before taking mifepristone, she says.
The FDA’s relaxed rules still require women to sign the same form and be prescribed the drug by specially certified health care providers; the only change is that now they no longer have to physically go to a clinic. Abortion pills will still not be available in regular pharmacies, but they are now a little easier to access and pregnancies can be terminated safely from home.
Why has the FDA lifted its restrictions on abortion pills?
In April, the FDA announcement that it would allow mifepristone to be prescribed during telehealth visits and mailed throughout the duration of the COVID-19 pandemic; this month’s decision made that change permanent. Recently published Centers for Disease Control and Prevention The data found that 54% of abortions performed before 10 weeks (and 42% of all abortions) were with medication in 2019.
âPeople who live away from providers who have access to mifepristone, which has been severely limited due to these FDA rules, can get treatment sooner,â says Dr. Godfrey. âThis is important because when people have to travel long distances their care is often delayed and because of the delay in care they have more complications. “
A wealth of data collected over two decades has shown that mifepristone is both safe and effective, says Dr. Godfrey. 4.9 million people have safely terminated pregnancies using mifepristone since September 2000, when the drug was first approved by the FDA. (Note: The FDA reports that 26 drug-related deaths, but that these deaths âcannot be attributed with certainty to mifepristone. “)
“In this country, there are about 6 million pregnancies per year,” says Dr Godfrey. âAbout a third of these end in miscarriage and another quarter of these end in pregnancy termination. We are talking about millions of people who potentially have better access to care.
What is happening now?
Despite the FDA’s decision, 19 states, primarily in the South and Midwest, do not allow telehealth appointments for medical abortions. Patients in those states must travel without restrictions to benefit from the recently relaxed abortion pill regulations, says Dr Godfrey.
And the solution isn’t perfect: Providers still need to register with the drug’s manufacturer, which means healthcare systems can choose not to provide mifepristone to their patients, even if individual doctors prescribe it. ‘they could. For example, continues Dr. Godfrey, the VA does not cover abortion and providers affiliated with a religion will likely refuse to enroll. Patients who hope to have access to abortion pills will be forced to seek help elsewhere.
“It’s just a politically motivated restriction that really separates the haves from the have-nots in this country,” says Dr Godfrey. “The FDA needs to lift all of its restrictions, but it was a victory.”
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