restrictions, restrictions, restrictions
The most important news in healthcare: Thursday, January 14
The vaccine roll-out continues, with some states starting to move on to Phase 1b. This opens up vaccinations to people ages 65 and over and to many essential employees such as teachers, public transportation workers and police departments. In New York, that means that more than 7 million residents just became eligible for immunization. As of January 13, approximately 11 million doses have been administered in the U.S.
Today we’re covering an important story that could otherwise be lost in a wave of vaccine and Capitol related news: the Supreme Court’s decision to limit access to abortion medication amidst a pandemic. Read on to learn more about the first abortion case since Justice Amy Coney Barrett joined the Court.
Today’s Pulse is 800 words, or a 6 minute read.
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Healthcare PolicySupreme Court grants Trump administration request to restrict access to abortion drug
A package of mifepristone. Source: NPR
The pulse:
On Tuesday, the Supreme Court granted the Trump administration’s request to reinstate a federal regulation that women must pick up pills for medical abortions from a medical provider, rather than at a local pharmacy. We’re going to explain why that rule should have never existed and why it’s especially egregious during a pandemic.
Medical Abortions
“Medical abortions” are done using two drugs, mifepristone and misoprostol, and can be used up until 10 weeks of pregnancy. Importantly, both drugs need to be taken together for an effective abortion. While misoprostol can be obtained at a pharmacy like most other prescription drugs, mifepristone had to be dispensed at a clinic or hospital up until recently.
Wait a second, why can’t you get mifepristone at CVS?
Back in 2000 when the FDA approved mifepristone for medical abortions, it could not be sold at pharmacies because the agency wanted to monitor its safety profile. Mifepristone has been under a group of regulations called Risk Evaluation and Mitigation Strategy (REMS) set aside for the riskiest drugs with dangerous possible side effects that warrant monitoring. As part of REMS, mifepristone must be picked up at a doctor’s office or healthcare clinic, though it can be taken at home, unsupervised.
So is Mifepristone a dangerous drug?
In short, no. Despite being one of the FDA’s most heavily regulated drugs, mifepristone is incredibly safe and in fact has a better safety record than common antibiotics such as penicillin. Since 2000, approximately 24 women out of 3.7 million have died after taking mifepristone and misoprostol for medical abortions. Almost half of these deaths were unrelated to the medication (e.g. homicides, opioid overdose). There have been 13 deaths that were “probably or possibly related” to the medication since 2000, a death rate of 0.00035%. For reference, there were 522 reported deaths in men taking the erectile dysfunction drug Viagra (which can be easily picked up at virtually any pharmacy with a prescription) after just 13 months on the market. Even highly addictive opioids such as Oxycodone can be obtained at the pharmacy with a prescription, despite hundreds of thousands of deaths attributable to the opioid epidemic in recent years. Despite over 20 years of data proving mifepristone to be an incredibly safe drug, it continues to be under REMS.
Has the COVID-19 pandemic changed anything?
For a short while, yes. Back in July, a federal judge suspended the rule that mifepristone had to be picked up in person from a medical provider, largely in response to organizations such as the American College of Obstetricians and Gynecologists who argued that this created a significant barrier to abortion access during a pandemic. However, the Trump administration recently requested an appeal to the suspension, and the Supreme Court bit.
Why is this such a big deal?
Extra trips to the doctor’s office during a pandemic is a risk many would rather avoid. It’s particularly risky for patients who rely on public transport. As Justice Sonia Sotomayer explains “three-quarters of abortion patients have low incomes, making them more likely to rely on public transportation to get to a clinic to pick up their medication.” However, it is also important to consider that in many parts of the country, there are very few clinics that will offer mifepristone. Some women report traveling hours to find a clinic in their state where they can pick it up. Obtaining mifepristone can be a serious barrier to a safe and effective abortion, particularly in rural communities or medically underserved areas.
How did the Supremes come to this decision?
The Court voted 6-3 in favor of re-instating the strict regulations on mifepristone, with liberal justices Sonia Sotomayor, Elena Kagan, and Stephen Breyer dissenting. The Court did not release a majority opinion. This has been the first ruling on abortion law since justice Amy Coney Barrett has been sworn in and the court has shifted to a 6-3 conservative/liberal split. In a dissenting opinion, Justices Sonia Sotomayor and Elena Kagan said:
Government policy now permits patients to receive prescriptions for powerful opioids without leaving home, yet still requires women to travel to a doctor’s office to pick up mifepristone, only to turn around, go home, and ingest it without supervision…[The FDA rule] imposes an unnecessary, irrational, and unjustifiable undue burden on women seeking to exercise their right to choose.
Bottom line it for me:
There’s no medical evidence or sound logic as to why mifepristone continues to be one of the most highly regulated drugs in the US. During a pandemic, barriers to abortion access are downright irresponsible. Most concerningly, this decision may be foreshadowing serious upcoming challenges to historic abortion rulings such as Roe v. Wade by a heavily conservative Supreme Court.