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The US Food and Drug Administration is attacking organizations that sell pills for medical abortion on the Internet.
In a warning letter issued Tuesday, the agency asked its provider of online abortion pills AidAccess.org to immediately stop selling unapproved versions of mifepristone and misoprostol and to Advance, and respond to FDA concerns within 15 working days, specifying the measures taken to remedy regulatory infractions.
"Failure to [do so] may result in regulatory action by the FDA, including a seizure or injunction, without further notice, "said a spokesman for the agency in Vox.
The FDA has also sent a warning letter to Rablon, an online pharmacy network of at least 87 websites, such as AbortionPillRx.com and AbortPregnancy.com, selling mifepristone and misoprostol directly to patients.
In the US, legal versions of mifepristone and misoprostol have been available since 2000, but patients can not get them from any pharmacy. Drugs are only distributed by licensed health care providers in a doctor's office, clinic or hospital. Providers must sign a waiver stating that they will ensure that patients have access to surgical abortion or emergency care in the event of a problem – as part of an FDA risk mitigation program called REMS, common to higher risk drugs.
When retailers sell unapproved versions of drugs outside the REMS program – which the FDA has declared as Aid Access and Rablon – "the FDA has full regulatory authority to take action," said Tim Mackey, an expert on Counterfeit San Diego School of Medicine drugs. (In the case of Access Help, the pills are imported from India.)
However, reproductive rights groups and physicians have long considered REMS as a "medically unnecessary" barrier to women seeking access to safe abortion. And Aid Access, which was launched by Dutch physician and activist Rebecca Gomperts, appeared in the US last year in a very special context.
With the gradual reduction of access to abortion in US states, Brett Kavanaugh's confirmation to the Supreme Court and the future of Roe v. Wade Appearing increasingly sinister, women who wish to end their pregnancy safely are faced with an increasing number of obstacles. For example, Aid Access offers what Gomperts' other Women on Web service has been doing for years in patients in other countries with limited health care systems: quick access to medication abortion pills.
But as the site sells unapproved versions of drugs outside of REMS, the FDA is tackling this – as part of a broader crackdown on illicit drug sales online. "We have been very active in combating illegal online sales of unapproved drugs," said an agency spokesman at Vox. "It's not about the particular product. This is as usual for the FDA. "
Reproductive rights advocates, however, see the repression in a slightly different way: this is another measure that will make it more difficult for patients to undergo a safe abortion. "As access to abortion services in clinics is becoming increasingly limited due to legal restrictions, more women may turn to these websites for solutions to end an unwanted pregnancy," she said. Daniel Grossman, Professor in the Department of Obstetrics, Gynecology, and Reproductive Sciences at UCSF.
Instead of sticking to these websites, continued Grossman, the FDA "could better use its resources to explore how unnecessarily medical restrictions" of drugs – through the risk mitigation program – " could be mitigated to improve access to non-abortion care. "
In the United States, women face arrests and jail sentences for self-managed abortions
Although abortion is still legal in the United States, self-managed abortions have been considered criminal in many states and people have rarely been subject to arrests, sentencing, or imprisonment. imprisonment or police investigations.
"Many think it's easy to have an abortion in the US, but that's not the case," Vox Jill Adams, strategy director of the SIA's legal team, told IRIN. lawyers specialized in self-managed abortions. "Resourceful people are looking for solutions to end pregnancy in a safe, affordable and appropriate way." (According to Gomperts, she reportedly filled 600 US prescriptions in six months last year.)
Obtaining an abortion by mail from Aid Access works as follows: the patients are examined during an online consultation about their pregnancy and their medical history. If they meet specific criteria – healthy, pregnant less than 10 weeks old, living less than an hour from a hospital – Gomperts performs a prescription and sends it to a hospital. pharmacy in India that she knows and trusts.
The pills are then sent from India to the woman's home for a fee of US $ 95 (although Aid Access says it will find a way to help patients who can not pay). And patients can access instructions and support in real time as needed.
The two drugs prescribed by Gomperts – again, mifepristone and misoprostol – work in combination to induce miscarriage early in pregnancy. The World Health Organization regards these drugs as essential drugs, that is, they are supposed to be available to the population in all functioning health systems at all times.
If taken before 10 weeks, mifepristone and misoprostol are 92-98% effective. Thus, unsuccessful abortion is rare when patients use these medications as directed by the physician, according to UpToDate, the physician's database on medicine.
The access approach has proven to be safe, but it is not without risk. And we know much less about Rablon.
The WHO has also studied the safety of mifepristone and misoprostol when they are self-administered at home compared to a clinic and given the go-ahead to the home-based approach. "There is no evidence that home medical abortion is less effective, safe or acceptable than medical abortion clinics," concluded the WHO report.
In the United States, the experts in reproductive medicine also consider that these drugs are reliable and systematic. "Medical abortion with mifepristone and misoprostol in the first trimester is very safe," said Grossman, "with serious complications occurring in less than 0.5% of patients."
But that does not mean that all pregnant women can take these medications – or that the pills are safe. According to UpToDate, a number of groups should avoid mifepristone and misoprostol, including those with ectopic pregnancy (or a pregnancy that develops outside the uterus, which can only be confirmed by the Medical imaging), those with an intrauterine device in place, and those who suffer from chronic adrenal insufficiency or who are undergoing prolonged treatment with corticosteroids.
As with all medications, there are potential side effects, most commonly abdominal pain, excessive bleeding and gastrointestinal discomfort. Although more serious complications are rare, they occur. These may include hemorrhage, infection or fatal sepsis. (This is why Gomperts will only administer drugs to patients who are near a hospital.)
With the Gomperts service, there are additional security issues. Again, the drugs that patients receive are not approved by the FDA: they go through a pharmacy based in India. This means that US health regulators do not monitor and there is a risk of adulteration or improper dosage. (Grossman noted that US researchers had ordered mifepristone and misoprostol online from India for a recent study and had discovered that mifepristone-based products contained the correct dose, but that some of the misoprostol tablets were "degraded and less powerful than they should have been".)
There is also the risk that a patient will have an ectopic pregnancy without knowing it. In these cases, the drugs will not work.
But so far, published data on Gomperts' approach suggest that it is very healthy. For a study published in the British Medical Journal, Gomperts and other researchers analyzed the health effects of 1,000 patients who used home-abortion services in Ireland and Northern Ireland between 2010 and 2012. The main findings are:
In total, 94.7% reported having successfully completed their pregnancy without surgery. Seven women reported receiving a blood transfusion and 26 received antibiotics (the route of administration (IV or oral) could not be determined). No family members, friends, authorities or media reported any deaths following the intervention. Ninety-three women reported having a symptom for which they were advised to see a doctor, and 87 of these sought attention. None of the five women who did not see a doctor had an adverse outcome.
However, the paper has some caveats: Data has been self-reported, which means that women may not always have accurately told their stories. And the study may not give a complete picture of patients using the service.
Here's why: During the period reviewed by the researchers, 1,636 patients received pills and Gomperts only had follow-up information for 1,158 (or 71%). Of these, 1,023 confirmed that they used the drugs, and follow-up information was available for 1,000 people. The data is therefore based on a subset that ordered pills for abortion through the Gomperts, and there is a chance that if they had a more complete dataset, the situation in security matter would change.
Even less is known about Rablon's approach. The network has at least 87 domain names, such as OnlineAbortionPillRx.com and AbortionPillsRx.com – and the pills they offer have not been studied in the same way as Aid Access. According to the FDA, their "Abortion Pill Pack", a combination of mifepristone and misoprostol tablets, is not approved by the agency and does not contain appropriate instructions either.
Some have been arrested for using these pills
However, as the US government tries to crack down on access to abortion, these websites will become increasingly important, even if they are not always legal.
Seven states have criminal laws directly banning self-induced abortion. Advocates of abortion rights said they were illegitimate and unconstitutional. Prosecutors in a few other states have interpreted their fetal harm and fetal homicide laws to also limit self-managed abortions.
"When a prosecutor decides to punish a person who ends his own pregnancy, the law says that the law is almost secondary," said Adams, of the SIA. And although the risk of police intervention is low, "anyone who buys pills from a foreign pharmacy can be stopped, the US law allowing the importation of prescription drugs only in very limited cases"
I asked Adams how many times people have been sued in this country as a result of self-administered abortions. She said at least 21 people were arrested – and some jailed – for terminating their own pregnancy or helping another person to do so. Each case was different, but most often, patients were treated by doctors after seeking medical attention as a result of a voluntary abortion, or by friends and family who were aware of their plans. Adams thinks that the total number of people arrested is probably much higher than the cases of which SIA is aware.
About the FDA crackdown, she told Vox, "We want the FDA to focus on improving people's access to affordable abortion pills, instead of getting them." Impose unnecessarily medical restrictions that push this essential drug out of reach, especially for communities already facing the most important health care hurdles.
"No one should be afraid to be arrested or investigated for self-sustaining an abortion or for supporting someone who has decided to end their own pregnancy. Instead of targeting people to be punished, we should make sure that people can access the abortion care they need, in a way that suits them. "
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