by Ushma D. Upadhyay
On Jan. 3, the U.S. Food and Drug Administration took a first step toward making abortion pills available at retail pharmacies. It released new rules outlining how both bricks-and-mortar and mail-order pharmacies can get certified to dispense mifepristone, the first pill in a medication abortion. But the agency also left in place unnecessary restrictions, showing how far we have to go in offering access.
As a public health researcher and abortion safety expert, I welcome efforts to make abortion pills more easily available. Research shows that medication abortion has a safety rating of over 99%. A pregnant person should be able to simply message their primary care provider about their unintended pregnancy and get a prescription for abortion pills filled at their local pharmacy, the way we obtain many other time-sensitive prescriptions.
There’s been progress. At the end of 2021, the FDA updated its rules to allow patients to receive the medications by mail following a telehealth appointment, a method that our team of researchers at the University of California, San Francisco has found to be safe and effective. Last week’s announcement opens the door to all pharmacies to dispense mifepristone.
However, the FDA also introduced a new unnecessary regulation: that pharmacies must be certified to dispense mifepristone. This requirement has absolutely no basis in science. Pharmacies dispense thousands of other medications every day without needing a specific certification for each one. It is just another hurdle and hassle that will deter pharmacies from selling this essential medication.
The FDA also kept in place a preexisting requirement that the clinician who calls in the prescription be certified, unlike prescribers for most other medications. The certification process is fairly simple, requiring that clinicians who prescribe medication abortion be able to assess the gestation of the pregnancy (which research indicates can accurately be done based on the date of the patient’s last menstrual period and other medical history), diagnose ectopic pregnancies and provide treatment or referrals for complications.
However, certification additionally means that a clinician who wants to prescribe abortion pills using a pharmacy must submit a prescriber agreement form to the specific pharmacy location filling the prescription, which will vary based on patient choice. Having to complete this prescriber certification for every pharmacy each patient wants to go to could be too large a hurdle for some clinicians. Studies from other countries, including Canada, show that any licensed health care professional can prescribe mifepristone and any pharmacy can dispense the medication without compromising safety.
Another unjustified FDA requirement is that patients and prescribers must sign a patient agreement form. This extra step does not exist for most other prescription medications, including ones with greater risks. Similar to a medication drug label, the patient agreement form includes useful information on signs of a complication and the small likelihood of needing an additional procedure to complete the abortion. But it is unclear why in this case both clinicians and patients must sign this form acknowledging precautions already on the drug label.
Now that abortion care is virtually inaccessible in 13 states, it’s imperative to remove as many barriers as possible where it remains legal. #WeCount, a recent nationwide analysis that I co-led, looked at access in the first two months after last year’s Supreme Court decision in Dobbs v. Jackson that removed constitutional protections for abortion. We found that states where abortion care remained legal, such as Illinois, North Carolina, New York and Florida, saw thousands more patients than they did before Dobbs. Expanding access to medication abortion can help meet these dramatic surges in demand and reduce appointment waiting times at clinics.
With Roe v. Wade overturned, anti-abortion activists are now coming after abortion pills. They know these are increasingly popular — more than half of all U.S. abortions are done with medications. In November, an anti-abortion group sued the FDA to try to remove mifepristone from the market, questioning its safety using bunk science. The public should be aware of mifepristone’s strong record: It has been used by nearly 5 million people in the U.S. since its approval in 2000 and is safer than Tylenol or Viagra.
Since the Dobbs decision, health care advocates have been looking to the federal government to take stronger action to protect people’s rights to bodily autonomy. President Joe Biden directed Health and Human Services “to identify all ways to ensure that mifepristone is as widely accessible as possible.”
That promise is still far from being fulfilled. The Biden administration can assert the FDA’s authority to preempt state law on FDA-approved medications in efforts to prevent states from banning medication abortion, and explore other avenues to make the pills more available.
Last week’s announcement at least shows an intent to expand access through retail pharmacies. But the FDA is maintaining other restrictions on this essential medicine without medical justification. Instead of yielding to anti-abortion pressures, the FDA needs to follow the science on mifepristone.
