by Carla Murez
Health Day Reporter
WEDNESDAY, Jan. 4, 2023 (HealthDay News) — The U.S. Food and Drug Administration finalized a regulatory change on Tuesday that would allow retail pharmacies to offer abortion pills.
Until now, patients had only been able to get the two-drug drug through clinics, doctors and a handful of mail-order pharmacies.
The announcement came after Danco Laboratories and GenBioPro, the two companies that make the drug, received the FDA’s change notice.
“At a time when people across the country are struggling to access abortion care, this modification is critical to expanding access to medical abortion services and will provide healthcare providers an additional way to provide their patients with safe and effective end abortion options. Early pregnancy,” Danko said in a statement.
“Today’s FDA announcement expands the range of medications necessary to achieve reproductive autonomy and is a step in the right direction, which is especially important for increasing access to abortion care,” said Evan Masingill, CEO of GenBioPro. Company makes generic mifepristone, he tells New York Times.
Mifepristone is the first drug used in abortion protocols, followed by the less restrictive misoprostol. Although mifepristone blocks the hormones your body needs to conceive, misoprostol can cause contractions when taken about 24 to 48 hours later.
Misoprostol is also used to treat many other conditions. Mifepristone is only approved for miscarriages, but it can also be used to treat some miscarriages. Dozens of organizations, including medical groups, have petitioned the FDA to make the drug easier to use for abortion, Second-rate report.
Patients still need a doctor’s prescription to get their medicines, and pharmacies must follow certain rules for dispensing them.
A recent report showed that more than half of all pregnancies terminated in the United States were terminated using the abortion pill. They are now in higher demand as states imposed abortion restrictions after the U.S. Supreme Court overturned Roe v. Wade last June.
The American College of Obstetricians and Gynecologists applauded the move.
“Allowing brick-and-mortar pharmacies to join mail-order pharmacies in dispensing mifepristone for reproductive health indications would further improve patient access,” the group said in a statement. Fepristone, like other prescription drugs, allows more patients to access abortion care without clinically unnecessary barriers. This change will enable patients who choose medical abortion to choose to go if it is the right thing for them. Instead of waiting for mail order, go to the pharmacy and get immediate medical attention.”
“While today’s FDA announcement will not address access for everyone who seeks abortion care, it will allow more patients who need mifepristone for medical abortion to have more options to ensure the safety of this important medication,” the organization added.
Now it’s up to pharmacies to decide whether to offer them.
They need to designate an employee to ensure compliance, which can be a barrier, Second-rate report. Abortion bans or restrictions in some states can also make it illegal or difficult to provide birth control pills, Second-rate report. Even if the pills are legal, pharmacies may face customer demand and public pressure.
A Danco official said the company expects smaller independent pharmacies to offer the drug first. Larger chains will need to enforce the company’s requirement that the name of the prescriber, Second-rate report.
It could look like CVS or Walgreens can’t list doctors’ names in company-wide databases and instead limit the information to specific stores, a Danco official, speaking on condition of anonymity because the company fears threats from abortion opponents, told Second-rate.
Danco officials added that some prescribers may be more likely to prescribe the drug if they don’t have to store the drug themselves.
“For some people, this will greatly increase their ability to access medications and even consider them an option,” Danco officials said. “For others, not necessarily. Maybe they don’t want to go into their little mom-and-pop pharmacy. They’d rather receive it by mail order because then there’s no interaction.”
Since the Supreme Court ruling, the federal government has taken various steps to expand access to the abortion pill, including an initiative to enable telemedicine abortion services to conduct medical consultations with patients via video, phone or online questionnaires, Second-rate report.
Healthcare providers still need to be certified to demonstrate their knowledge and ability to treat miscarriage patients.
The FDA has more information on abortion pills.
resource: New York Times