By Cara Murez and Robin Foster HealthDay Reporters>
WEDNESDAY, Jan. 4, 2023 – The U.S. Food and Drug Administration finalized a regulatory change on Tuesday that allows retail pharmacies to offer abortion pills.
Before now, patients could only get this two-drug medication through clinics, doctors and a handful of mail-order pharmacies.
Two companies that make the medication, Danco Laboratories and GenBioPro, announced the news after they were notified by the FDA of the change.
“At a time when people across the country are struggling to obtain abortion care services, this modification is critically important to expanding access to medication abortion services and will provide healthcare providers with an additional method for providing their patients with a safe and effective option for ending early pregnancy,” Danco said in a statement.
“Today’s FDA announcement expands access to medications that are essential for reproductive autonomy and is a step in the right direction that is especially needed to increase access to abortion care,” GenBioPro CEO Evan Masingill, which makes the generic version of mifepristone, told the New York Times.
Mifepristone is the first pill used in the abortion regimen, followed by misoprostol, which already had fewer restrictions. While mifepristone blocks a hormone the body needs for a pregnancy to develop, taking misoprostol about 24 to 48 hours later causes contractions.
Misoprostol is also used to treat many other medical conditions. Mifepristone is only approved for abortion, but it is also used to treat some miscarriages. Dozens of organizations, including medical groups, have petitioned the FDA to make the drug easier to access for miscarriages, the Times reported.
Patients will still need a doctor’s prescription to access the drugs, and pharmacies must follow certain rules to dispense the medication.
Abortion pills are used in more than half of U.S. pregnancy terminations, a recent report showed. They are now in even higher demand because of abortion restrictions enacted by states after the U.S. Supreme Court overturned Roe v. Wade last June.
The American College of Obstetricians and Gynecologists applauded the move.
“Allowing for brick-and-mortar pharmacies to join mail-order pharmacies in dispensing mifepristone for reproductive health indications will further improve access for patients,” the group said in a statement. “ACOG has long advocated that mifepristone be made available in retail pharmacies, just like other prescription drugs, to allow more patients access to abortion care without clinically unnecessary hurdles. This change will empower patients who choose medication abortion to have the option of going to a pharmacy for immediate care rather than waiting for a mail order, if that is right for them.”
“Although the FDA’s announcement today will not solve access issues for every person seeking abortion care, it will allow more patients who need mifepristone for medication abortion additional options to secure this vital drug,” the group added.
Now it’s up to pharmacies to decide whether to offer them.
They would need to designate an employee to ensure compliance, which could be a barrier, the Times reported. Abortion bans or restrictions in some states would also make it illegal or difficult to offer the pills, the Times reported. Even where the pills are legal, pharmacies may face customer demand and public pressure.
A Danco official said the company expected smaller, independent pharmacies to offer the drug first. Bigger chains would need to implement the companies’ requirements that keep confidential the names of providers who prescribe the drugs, the Times reported.
That might look like CVS or Walgreens not being able to list a doctor’s name in a companywide database but instead restricting that information to the specific store, the Danco official, who spoke on the condition of anonymity because of the company’s concerns about threats from abortion opponents, told the Times.
Some prescribers may be more likely to prescribe the drug if they didn’t have to stock it themselves, the Danco official added.
“For some people, this is going to be a huge improvement on their ability to access the drug and be able to even consider this as a choice for themselves,” the Danco official said. “For other people, not necessarily. Maybe they don’t want to go into their small mom-and-pop pharmacy. They’d rather receive it from a mail order where there’s just no interaction that way.”
The federal government has taken various steps to expand access to abortion pills since the Supreme Court decision, including a move that made it possible for telemedicine abortion services to conduct medical consultations with patients by video, phone or online questionnaires, the Times reported.
Health providers will still need to be certified to show they have the knowledge and ability to treat abortion patients.
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Posted January 2023
