The US Food and Drug Administration is going after at least one website that sells abortion pills online, according to an agency statement.
AidAccess.org provides an online consultation to assess whether women qualify to receive mail order drugs to end a pregnancy.
Medical abortion was deemed a safe and effective way to end an unwanted pregnancy within its first 70 days by the FDA in 2000.
But access to the drugs is subject to state laws as well and is often more limited for certain groups, such as minors, the LGBTQ+ community and people who live in poor or rural areas.
Aid Access made waves last year when it began offering the most affordable way yet for US women to get abortion pill prescriptions via telemedicine and a foreign pharmacy.
But as many anticipated, the FDA has now warned Aid Access that its activities amount to the sale of ‘misbranded and unapproved new drugs’ in the US, meaning it will face legal consequences if it continues to prescribe in the US.
Mifipristone, previously known as RU486 is one of two drugs that, in combination, can terminate a pregnancy. Aidaccess.com is an online service that gives women a consultation, fills a prescription for the abortion pills in India and send them to the US. The FDA says it can’t
More than 45 years after the Supreme Court legalized abortion in the landmark Row v Wade decision, the subject is back in the spotlight – and surrounded by controversy on all sides.
An abortion is typically completed via a simple procedure, called a dilation and curettage (D&C), which involves the scraping of the uterine lining where a fertilized egg implants.
It’s low risk, but some women find it traumatic, others can’t afford it, and for others, getting into a clinic that could perform a D&C is next to impossible.
About one in four women has an abortion by the time they are 45, according to recent research.
Yet nearly as many (20 percent) have to travel 42 miles or more to get to a clinic.
A number of those women live in areas in the Midwest and South where there are tougher laws about the timing of abortions, how many doctors visits are needed and what a woman must go through before an abortion.
The advent of the so-called ‘Plan C’ set of abortion pills – containing Mifepristone and Misoprostol – was a source of hope and comfort to many who looked forward to being able to take the simple drug in the privacy and comfort of their own homes.
Some of those states, including Texas, North Dakota and Ohio also have laws that require women and their doctors to strictly adhere to the FDA’s instructions on the pills’ label, which is meant to further restrick its use.
But in 2016, the FDA actually relaxed the guidelines it put on those labels. It made the dosage lower, reduced the number of doctor’s visits a woman had to make from three to two approved the drug for use up to 10 weeks into a pregnancy (instead of seven).
The move was seen as a major victory by proponents of abortion rights, but now the FDA is once again acting against these groups’ hopes by going after organizations like Aid Access.
‘Aid Access supports women who cannot otherwise access an abortion and protects their human rights,’ Aid Access’s site explains.
‘Unfortunately some countries violate human rights and try to prosecute women who induced their own abortion.’
The European group came to see the US as one of those countries and began connecting women need with doctors that could prescribe the abortion cocktail from afar and mail them to women’s homes for just $95 (far less than the $350-$950 it costs to get an abortion in the first trimester).
A report also rated Aid Access highly for providing doctor consultations and the organization received over 3,000 requests from women in the US between April and November 2018, its founder Dr Rebecca Gomperts told CNN.
But as promised in October, the FDA is now after Aid Access.
Although mifiprsitone and misoprostol tablets are FDA-approved, the agency argued that the particular marketed by Aid Access are not.
Earlier this year, a Columbia University study found that there were 18 sites where abortion drugs could be purchased online.
All of the mifepristone pills were within eight percent of the active ingredient they claimed to be.
The misoprostol pills also contained the claimed ingredient, just somewhat smaller amounts.
But the researchers ultimately agreed that these online options were very viable and rational’ ones for women with poor access to care to consider.
The FDA disagrees.
‘FDA is taking this action against Aidaccess.org because of the risks posed by its conduct in causing the introduction of a misbranded and unapproved new drug into US commerce,’ the letter said.
The FDA has given Aid Access 15 days to respond to its cease and desist letter.