Analysis | New FDA Rules On Abortion Pills Leave Too Many Hurdles

Analysis | New FDA Rules On Abortion Pills Leave Too Many Hurdles

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Recent decisions by the US Food and Drug Administration and the two biggest pharmacy chains are bringing the post-Roe v. Wade landscape more clearly into focus. America is becoming a country where abortion is a crime in some states but just a normal part of health care in others. 

This week, the FDA announced that retail pharmacies will be allowed to dispense mifepristone and misoprostol, drugs used to induce abortion in the first trimester of pregnancy. Until now, the pills could be obtained only directly from the prescriber or, under temporary pandemic-era rules, from mail-order pharmacies. The two biggest pharmacy chains — CVS Health Corp. and Walgreens Boots Alliance Inc. — quickly confirmed they would seek to become certified to sell the drugs, often known by the brand name Mifeprex.

The revised rules are a move in the right direction, at least for states where abortion is still legal. But the rule change amounts to a rather tentative step. The FDA should have gone further and dropped the needless hurdles that will complicate retail pharmacies’ efforts to dispense the medication.  

Because more than half of abortions in the US are induced by pills (as opposed to a surgical procedure) any change to how the medication is prescribed will be hugely influential for tens of thousands of people. And together, CVS and Walgreens control roughly 40% of the market for prescription drugs sales. But in the 13 or so states where abortion has either been criminalized or severely restricted, drugstores will be exceedingly unlikely to dispense these pills, even though they are also used to treat miscarriages.

Under the old guidelines, medical providers who prescribed the pills — whether the brand-name offering from Danco Laboratories or the generic from GenBioPro — had to stock the medication themselves and sell it directly to patients. That means access was mostly limited to abortion clinics.  That isn’t how most prescriptions work. When you need antibiotics or blood pressure medication, your doctor doesn’t sell it directly to you. He or she submits it to a pharmacy, where you pick it up. 

The old FDA rules meant that some women had to drive hundreds of miles to their nearest abortion clinic just to pick up a prescription. While telehealth and mail-order pharmacies improved access for some women, it wasn’t a viable solution for people with limited internet access or who worried about others in their household seeing their mail. 

The new guidelines do away with the requirement that prescribing doctors dispense the pills directly, which makes it more likely that more providers will start prescribing them. They make permanent some pandemic-era rules that allow pills to be dispensed following telehealth appointments. And the announcements by Walgreens and CVS mean it is much more likely that more people will be able to get these medications directly from a corner drugstore; Walgreens brags that 78% of the US population lives within five miles of one of its stores, and 85% of Americans live within 10 miles of a CVS.

But the FDA’s new rules compel pharmacies to jump through additional hoops to be “certified” to dispense Mifeprex. While CVS and Walgreens seem willing to go through the hassle, the certification requirement isn’t medically necessary. Pharmacies don’t need to go to these lengths to dispense, say, Viagra. The additional regulation might scare away smaller pharmacies from stocking the drugs, which aren’t terribly profitable.

The certification requirement also puts a stigma around use of these pills. It could foster doubt among the public about the drugs’ safety — after all, if the drugs were safe, why would they need additional regulation?

Abortion medication has been used in the US for more than 20 years and has been shown to be safer than Tylenol. (And, for that matter, safer than Viagra.) For birth control pills, antibiotics or blood pressure medication, a pharmaceutical license is enough. Special certification is typically only required for drugs known to have serious side effects, such as thalidomide, which is used to treat leprosy and cancer but causes severe birth defects. The FDA should have said that a pharmaceutical license was sufficient to dispense abortion pills. 

The FDA could also have taken this opportunity to extend the window of authorization for Mifeprex, which currently only extends to 10 weeks of pregnancy. The World Health Organization says the drugs are safe to use through 12 weeks. 

That two-week gap could be the difference between having access or not for some women; the Centers for Disease Control and Prevention estimates that 12.2% of abortions happen between nine and 13 weeks. Moreover, although abortions after 13 weeks make up less than 7% of abortions, one of the biggest reasons is a lack of access earlier; women seeking abortions after 13 weeks are more likely to have struggled to find a provider, come up with the money, or both. Making pills easier to get earlier is one of the best ways to reduce later abortion.

Although the FDA didn’t go as far as it could have — or even as far as the science would dictate — the rule changes will make it easier for women to access early abortion in the states where it is legal. 

But in an era of intense political polarization, the only way science-based agencies like the FDA can stay above the fray and continue to command public trust is to hew closely to the facts. That means not layering political red tape onto medically safe drugs. 

More From Bloomberg Opinion:

• Abortion Clinics Shouldn’t Have to Stand Alone: Sarah Green Carmichael

• Where Abortion Will Be on the Ballot in 2024: Julianna Goldman

• Supreme Court’s ‘Nostalgia Doctrine’ Is Trump’s Biggest Legacy: Noah Feldman

This column does not necessarily reflect the opinion of the editorial board or Bloomberg LP and its owners.

Sarah Green Carmichael is a Bloomberg Opinion editor. Previously, she was managing editor of ideas and commentary at Barron’s and an executive editor at Harvard Business Review, where she hosted “HBR IdeaCast.”

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