Abortion drugs — regulation is the responsibility of the FDA, for now

I am going to write about something that has never been an interest of mine, but abortion drugs moved into my line of sight since the US Supreme Court decided to set aside 50 years of precedent and overturn Roe v Wade. Some states, especially what we call red states (those that vote for the right-wing Republicans) are trying to ban the sale of abortion drugs that are legally obtained by women.

Since I am someone who is very aware of FDA regulatory responsibilities, I immediately thought to myself that there is no way that states can do such a thing. Now, I am not an attorney nor do I play one on the internet, but I think the law is on my side. On the other hand, I never thought Roe v Wade would be overturned, so what do I know about the law?

Let’s take a look at abortion drugs and FDA regulatory responsibilities. I want to warn you before you read this — I am not agnostic about abortion. I am 100% pro-abortion — I believe that there is an absolute right for a woman to choose what she wants to do with her body and her healthcare, and that includes abortion. From a scientific perspective, fetal cells are not “alive” until such time that they are viable outside of the woman’s womb, around 23-24 weeks of gestational age. Before that time, fetal cells are invasive, and as such a woman has an absolute right to do whatever she wants with those cells.

So, if you don’t like that, you’re not going to like what I’m writing here, but I’ll live without your support.

For those of you who live in civilized countries where women are not treated as chattel property, hopefully, this article will give you some indication of what is going on in the USA at this time. And it’s not good.

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What are abortion drugs?

In a procedure called medical abortion, medically-prescribed drugs are given to a pregnant woman to induce an abortion. Medical abortions account for over half of abortions in the US and many other countries.

The two drugs that are most often used in medical abortions are mifepristone followed by misoprostol. However, in some cases, misoprostol can be used alone.

Mifepristone blocks the hormone progesterone, which causes the lining of the uterus to thin and prevents the embryo from staying implanted and growing. Misoprostol, a synthetic prostaglandin, causes the uterus to contract and expel the embryo through the vagina.

Even though it is not a medical abortion drug, I’m going to include Plan B, or Levonorgestrel, which is used for emergency contraception. Many of the laws that are trying to block abortion drugs are also tossing in Plan B for good measure.

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What are some states doing?

Basically, the red states are going about this in a variety of ways:

  1. Blocking the sale of these drugs in their state.
  2. Blocking telehealth who can prescribe the drugs.
  3. Blocking shipment of these drugs into the state.
  4. All of the above.

Now, I have no clue how they can block the shipment of these drugs into their states, short of opening every US Postal Service, UPS, or FedEx package that arrives in the state, which would break all kinds of laws.

However, the US Attorney General, Merrick Garland, stated:

States may not ban mifepristone based on disagreement with the FDA’s expert judgment about its safety and efficacy.

Now Attorney General Garland is not only saying this because the Biden administration supports women’s right to choose their own reproductive health but also because it is the law. The FDA has the sole responsibility to regulate pharmaceuticals, like abortion drugs, in all 50 states. In fact, the FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed, and veterinary products.

The Federal Food, Drug, and Cosmetic Act (FD&C), passed by Congress in 1938, gave authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics. It did not give any of those powers to the state.

There have been dozens of laws and court rulings that have mostly strengthened the FDA as the only arbiter of the legality of drugs. There are several legal points that I must make (and remember, I am not an attorney):

  1. Federal law is the supreme law of the land according to the Supremacy Clause of the US Constitution. FDA regulations (and approval of drugs) take precedence over state laws regarding abortion drugs.
  2. This has been confirmed by the US Supreme Court in Riegel v. Medtronic, Inc., which describes FDA preemption, a legal theory that exempts manufacturers (like drugs) from tort claims regarding their products that were approved by the FDA.

Based on the Supremacy Clause and FDA preemption, FDA regulations, including approval of drugs, cannot be undone or superseded by state law. Well, unless the Supreme Court undoes more precedent and allows states to regulate abortion drugs.

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Telemedicine

I wanted to add more information about how states might control the access to medical abortions by restricting telemedicine, that is receiving health advice and prescriptions online or by phone.

According to the Guttmacher Institute, 32 states require that the provider who administers a medical abortion be a physician (although the FDA allows certified providers including nurse practitioners or physician assistants to administer mifepristone). Nineteen states require the person providing a medical abortion to be present when the patient takes mifepristone, prohibiting the use of telemedicine for the procedure.

The FDA has stated that a medical abortion can be provided by telemedicine and the medication be delivered by mail. I’m sure courts will have to decide if the FDA has preemption in these matters too, which probably will mean another Supreme Court ruling.

So what options for medical abortions do patients in states that have banned abortion still have? Plan C, an organization that connects patients to abortion pill services, is one example that helps people find international providers or other online pharmacies that will dispense the medications.

Plan C directs patients to organizations such as Aid Access, an abortion pill provider based in Europe that ships abortion pills to people in the U.S. Patients can choose to consult with a provider, and self-manage their abortion at home.

Because Aid Access is a non-US provider, they are technically not subject to US regulations. The FDA under President Trump sent a warning letter to Aid Access in an attempt to stop them from distributing a “misbranded and unapproved new drug.”

Aid Access, however, ignored the warning letter, and they subsequently filed a lawsuit against the FDA for violating patients’ rights and placing an “undue burden” on the right to abortion. I’m sure the current FDA will overlook this.

Summary

It is very clear to me, a mere amateur in the field of constitutional law and the FDA, that the FDA approvals and regulations mean more than state law.

If this isn’t true, we would have pure anarchy in the regulation of drugs. Just think about the COVID-19 pandemic — there could have been states that approved the use of ivermectin and hydroxychloroquine for treatment of COVID-19, even though there was no evidence that they worked. Or maybe some states, run by anti-science Republicans, may have not “approved” the COVID-19 vaccine.

It looks like the Attorney General, who actually is a professional in constitutional law, is going to defend the FDA preemption and supremacy for drug regulations. Let’s hope that it works so that women do retain the right to get rid of non-living fetal cells from their bodies.


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The Original Skeptical Raptor
Chief Executive Officer at SkepticalRaptor
Lifetime lover of science, especially biomedical research. Spent years in academics, business development, research, and traveling the world shilling for Big Pharma. I love sports, mostly college basketball and football, hockey, and baseball. I enjoy great food and intelligent conversation. And a delicious morning coffee!