For the first time, the US Food and Drug Administration (FDA) will allow retail pharmacies to sell abortion pills in the country.
Pharmacy certification applications may now be sent to one of the firms producing the abortion drug Mifepristone.
According to pro-abortion activists, the pill has a long history of being reliable and secure, with no overdose or addiction risk.
Although more states want to outlaw medication abortion, the US Food and Drug Administration (FDA) has announced that it will allow retail pharmacies to sell abortion pills in the US for the first time.
On Tuesday, the organisation stated on its website that “Under the Mifepristone REMS Program, as modified, Mifeprex, as well as its approved generic, may be dispensed by Certified Pharmacies or through the supervision of a Certified Prescriber.”
The regulatory change may increase access to abortions as President Joe Biden’s administration struggles with how best to defend abortion rights following the landmark Roe v. Wade decision’s overturning by the Supreme Court and the state bans that followed it last year.
After considering supplemental apps from Danco Laboratories as well as GenBioPro, the two US manufacturers of the drug, the agency finally approved the changes.
Pharmacies can begin submitting certification applications to one of the two companies manufacturing the abortion drug Mifepristone. If approved, they can provide it directly to patients after receiving a prescription from a licenced physician.
When the FDA first declared it would loosen some risk evaluation as well as mitigation strategies, or REMS, on the pill that might be in place because the agency approved it in 2000 and that had been temporarily lifted in 2021 due to the COVID-19 pandemic, it did so in December 2021.
The modifications included the permanent removal of limitations on the prescription of the pills and their mail-order delivery via telehealth or remote healthcare.
Mifeprex, the brand name for mifepristone, induces abortions up to 10 weeks into pregnancy through the use of a second drug called Misoprostol, which also has several uses, including managing miscarriages.
The pill has a long history of being effective and safe, with no risk of overdose or addiction, according to pro-abortion activists. Women can purchase them over the counter in several nations, including Mexico and India, to induce abortions.
According to Planned Parenthood President Alexis McGill Johnson, “today’s news is a move in the right direction for health equity.”
For those attempting to obtain basic medical care, Johnson continued, being able to obtain their prescribed medication for abortion through the mail or to pick it up in person from such a pharmacy similar to any other prescription is a game changer.
However, not everyone will have equal access to the new regulations, according to a statement from GenBioPro, the company that manufactures the generic form of mifepristone.
Since the US Supreme Court invalidated the 1973 Roe v. Wade decision, which declared that women do not have a constitutional right to an abortion, abortion restrictions, some of which target the drug mifepristone, have been put into place in more than a dozen states.
Women from those states might cross state lines to obtain abortion-related medication.
Marjorie Dannenfelser, president of the pro-life organisation SBA Pro-Life America, claimed that the most recent FDA action puts women’s safety and unborn children’s lives in danger.
In a statement, she insisted that Congress and state legislators “must act as a bulwark against the Biden administration’s pro-abortion extremism.”
According to FDA records, there are a few deaths related to mifepristone. Out of the 4.9 million people believed to have taken it since it was first approved in September 2000, as of June 2021, there have been reports of 26 deaths associated with the pill.