The Joe Biden administration will now allow the abortion pill mifepristone to be sold in US pharmacies. The development gains significance coming in the aftermath of the US Supreme Court overturning Roe vs Wade and with it a woman’s decades-held right to choose control of her own body. Let’s take a closer look: What is mifepristone? The US Food and Drug Administration (FDA) is allowing pharmacies to distribute the abortion pill mifepristone. Mifepristone is usually taken in combination with a second drug called misoprostol to induce a medication abortion, as per BBC. It is important to note that women will need a prescription to purchase mifepristone. Misoprostol, used to manage miscarriages, is not a restricted drug. It can be obtained at pharmacies across America through prescriptions. As per CNN, women could previously gain access to both mifepristone and misoprostol through a certified health-care provider.
The FDA during the COVID-19 pandemic began allowing the pills to be sent via mail.
It also added it would no longer require people to get the drugs in person. Why is it important? The move, which could potentially expand abortion access for some, comes as President Joe Biden’s administration is grappling with what it can and cannot do for abortion rights. Pharmacies can start applying for certification to distribute abortion pill mifepristone with one of the two companies that make it, and if successful they will be able to dispense it directly to patients upon receiving a prescription from a certified prescriber.
This is also meaningful as research shows that more than half of US abortions are done with pills and not surgery, as per BBC.
The FDA had first said it would be making those changes in December 2021 when it announced it would relax some risk evaluation and mitigation strategies, or REMS, on the pill, that had been in place since the agency approved it in 2000 and were lifted temporarily in 2021 due to the COVID-19 pandemic. The changes included permanently removing restrictions on mail order shipping of the pills and their prescription through telehealth. The agency finalised the changes on Tuesday after reviewing supplemental applications from Danco Laboratories and GenBioPro, the two companies that make the drug in the United States. “Under the Mifepristone REMS Program, as modified, Mifeprex and its approved generic can be dispensed by certified pharmacies or by or under the supervision of a certified prescriber,” the agency said on its website on Tuesday. Now, retailers will have to decide whether or not to offer the drug given the inflammatory rhetoric surrounding the issue of abortion. What about women in states with abortion bans? Unfortunately, women in states where abortion is banned will likely not be able to get mifepristone. Women in such states would likely have to travel to other states to obtain medication abortion. GenBioPro which makes the generic version of mifepristone, released a statement saying the change would not provide equal access to all people.
Some states, which have banned abortion, have also passed laws targeting mifepristone.
However, Attorney-General Merrick Garland, in the aftermath of the Supreme Court ruling had cautioned states against banning drugs like mifepristone. [caption id=“attachment_9177891” align=“alignnone” width=“640”] File image of Merrick Garland. AP[/caption] “States may not ban Mifepristone based on disagreement with the FDA’s expert judgment about its safety and efficacy,” Garland said in a statement, as per CNN. Right step, say abortion rights activists Abortion rights activists and doctors’ groups have hailed the move. “Today’s news is a step in the right direction for health equity,” Planned Parenthood president Alexis McGill Johnson said in a statement. They say the pill has a long track record of being safe and effective, with no risk of overdose or addiction. In several countries, including India and Mexico, women can buy them without a prescription. “Being able to access your prescribed medication abortion through the mail or to pick it up in person from a pharmacy like any other prescription is a game changer for people trying to access basic health care,” Johnson added. The BBC quoted the American College of Obstetricians and Gynaecologists as saying, “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” “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,” CNN quoted manufacturer Danco as saying in a statement.
But not everyone is pleased.
The president of anti-abortion group SBA Pro-Life America, Marjorie Dannenfelser, claimed the latest FDA move endangers women’s safety and the lives of unborn children. “State lawmakers and Congress must stand as a bulwark against the Biden administration’s pro-abortion extremism,” she said in a statement. FDA records show a small mortality case number associated with mifepristone. As of June 2021, there were reports of 26 deaths linked with the pill out of 4.9 million people estimated to have taken it since it was approved in September 2000. With inputs from agencies Read all the Latest News , Trending News , Cricket News , Bollywood News , India News and Entertainment News here. Follow us on Facebook, Twitter and Instagram.