Washington D.C., Sep 10, 2019 / 06:06 pm (CNA).- Pro-life groups are decrying an effort by a European doctor to sue the United States Food and Drug Administration in order to continue selling medical abortion pills online.
Dr. Rebecca Gomperts is a licensed physician in Austria and the founder of Aid Access, a European company that prescribes and mails misoprostol and mifepristone, the drugs required for a medical abortion, to women in the United States.
In March, the FDA issued a cease-and-desist to Aid Access, ordering the group to stop prescribing and mailing the drugs to patients in the United States because they were unregulated.
On Monday, Gomperts, through attorney Richard Hearn, filed a civil action lawsuit in federal court in Idaho against the FDA, seeking the protection of the women who have received the prescriptions, and the protection of her group to continue selling the abortion drugs online.
In the suit, Gomperts claims that the FDA has seized up to 10 doses of the abortion drugs sent through the mail by Aid Access, and blocked some payments from patients made to Aid Access, since March.
Dr. Tara Sander Lee, a senior fellow and the director of life sciences with pro-life research group Charlotte Lozier Institute, said in a statement that it was “ludicrous” of Gomperts to sue the FDA, “a government agency charged with protecting the public health of women by assuring the safety and efficacy of any drug.”
“Far from being safe and effective, abortion pills from Aid Access have been shown to be damaged and contaminated, and these tainted drugs have caused serious—and sometimes even fatal—bacterial infections and excessive bleeding in women,” Lee said.
“It is fully within the FDA’s jurisdiction to protect women from harm and prevent these dangerous abortion pills from getting into the hands of any more women. That Aid Access is attempting to stop the FDA from doing their job proves they have no intention of ensuring the health and safety of women in the U.S.,” Lee added.
FDA-approved versions of the medical abortion drugs have been available to US consumers since 2000, but may only be prescribed by a certified health care provider in a hospital, clinic, or medical office setting. They may not be sold online or in a retail pharmacy.
The health care provider must inform patients about the serious risks associated with use of the medications, and sign a waiver certifying the patient has access to emergency care or a surgical abortion in the case of complication.
These requirements are part of an FDA risk mitigation program called REMS, which is used for all higher-risk medications. The March letter to Aid Access stated that the FDA-approved version of mifepristone, called “Mifeprex,” is under the REMS program because “the drug carries a risk of serious or even life-threatening adverse effects, including serious and sometimes fatal infections and prolonged heavy bleeding, which may be a sign of incomplete abortion or other complications.”
“The sale of misbranded and unapproved new drugs poses an inherent risk to consumers who purchase those products,” the FDA stated in the letter. “Unapproved new drugs do not have the same assurance of safety and effectiveness as those drugs subject to FDA oversight. Drugs that have circumvented regulatory safeguards may be contaminated; counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether.”
Hearn told NPR that Gomperts is operating out of a desire to provide abortions to women in remote parts of the U.S. who may not have easy access to a clinical abortion.
“Some women in the United States can exercise that right just by going down the street if those women happen to live in New York or San Francisco or other major metropolitan areas on either one of the coasts,” Hearn told NPR. “But women in Idaho and other rural states, especially conservative states…cannot exercise that right.”
Women who request medical abortions through Aid Access are seen by Gomperts in an online consultation, and if they are approved for the drugs, they are instructed on how to request them from a pharmacy in India.
According to the suit, between March 30, 2018 and August 27, 2019, Aid Access received thousands of requests for chemical abortions from women in the U.S. Gomperts claims that of these women, 7,131 have been prescribed misoprostol and mifepristone through Aid Access.
In its March letter, the FDA said that “by facilitating the sale of unapproved mifepristone and misoprostol to consumers in the U.S., Aidaccess.org causes the introduction of unapproved new drugs into U.S. commerce in violation of the FD&C Act.”
Gomperts told NPR that Aid Access briefly stopped prescribing the drugs after the FDA letter, but resumed the practice in May.
“The FDA is a huge institution. It’s very powerful, and it’s a form of intimidation that is quite severe,” Gomperts told NPR. “I would say a form of bullying. And so I think it’s very important to stand up against it.”
Aid Access is the sister organization of Women on Web, which sends medical abortion drugs to women seeking abortion in countries in which the practice is illegal, and Women on Waves, a boat that performs abortions in international waters in order to circumvent legal issues women may face.
The lawsuit comes just after Planned Parenthood announced an expansion of its telemedical services through its app, through which users can request birth control delivery, UTI treatment prescriptions, and appointments at Planned Parenthood.
According to its website, Planned Parenthood has also used telemedicine to prescribe mifepristone and misoprostol, the two drugs used in medical abortions. According to the Guttmacher Institute, 18 states require that a licensed physician be physically present during medical abortions, effectively banning abortions prescribed via telemedicine in those states.
Kristan Hawkins, president of pro-life organization Students for Life of America, recently testified to the dangers of RU-486, or medical abortions, in California. In her testimony, she noted that the FDA had previously updated its notes on the dangers of medical abortions.
“As of December 31, 2018, there were reports of 24 deaths of women associated with RU-486 since the product was approved in September 2000, including two cases of ectopic pregnancy resulting in death; and several cases of severe systemic infection (sepsis), including some that were fatal,” the updated FDA note states.
“To date, the report documents nearly 4,200 reported adverse effects, including hospitalization and other serious complications,” Hawkins said at the time.
Hawkins said in a Sept. 9 statement that Aid Access appears to want to prioritize profits over the safety of women.
“Protecting women from the known dangers of abortion-inducing drugs is good and safe policy,” Hawkins said.
“Risking women’s lives so that an international sales team for abortion pills can more easily operate is not in the interests of American women. It’s easy to understand why a profit-driven industry for chemical abortion pills wants fewer health and safety standards but protecting women from the known dangers of the pills is the right public policy.”
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What stuns me is how deeply and swiftly into a loss of a common sense the world is falling. Shouldn’t it be self-evident that, if a child’s normal puberty (hormonal production) is being blocked his fertility (and not only fertility) will suffer long term?
It appears to me that many modern people see their bodies as some plastic dolls – inject into that plastic shape some meds, shake it well and later, if it does not work, we can just pour out, rinse and be fine and try something else. The same attitude pervades those who happily go for plastic surgeries, I think. There is no normal apprehension “what if it will go wrong” before doing something drastic with one’s own body or the body of one’s own child. This, by the way, is sharply at odds with “a nature = Gaya worshiping”.
Puberty blockers and hormonal meds affect not only physical but psychological health as well. They can cause a wide spectrum of reactions, from severe depression and anxiety to psychotic elation. However, those “doctors” who usher them on the trans-road somehow do make a connection between the meds they already prescribed and the worsened mental symptoms, up to suicidal ideation. “Look how depressed you are” they say to a child/teen, “do not worry, take those meds and you will feel far better after we get your breasts/penis cut off”.
Anyone who thinks you can ply a human being with all kinds of hormones (even those that are contraceptives) – especially during the developmental years – and not cause damage to the organism are either certifiably insane, irreversibly stupid or evil (some win the trifecta). I also place in the same category those lemmings who take experimental and untested vaccines because the government tells them they should (and also shields the pharmaceutical companies that makes them from product liability lawsuits.)
Were you vaccinated? Do you also deny the validity of all other vaccines against diseases? If bit by a rabid animal would you refuse treatment? Do you really believe that the multiple attempts to find a way of preventing COVID around the entire globe was an evil conspiracy concocted by a much corrupted medical profession. Perhaps COVID was created and intentionally released by evil people for unknown reasons; but to believe that the attempt to treat the disease and prevent multiple deaths is evil makes no sense at all. Yes, it’s highly likely that some people took advantage of this situation for selfish and or evil purposes ( this is to be expected of our fallen human state ); but that does not negate the good intentions or motivations of those who produced the vaccines. It may be true that the vaccines were ineffective or even harmful, but we do not really know that and surely did not know it at the time . The epidemic was so sudden and unexpected and the nature of the virus so unknown, that there was not time to subject create and test possible treatments the way we usually do. Time was of essence and risks had to be taken. It’s easy for an armchair Monday morning quarterback to make judgements on a play; but it’s much a different situation for the quarterback himself in pocket in the heat of the game with sore muscles and dirty sweat in his eyes. He throws his best ball in spite of it all. No one can really judge him, because they were not him in his shoes. The same can be said for the whole COVID scenario. Let’s give thanks for the many good people who tried their best to save lives. Let’s at least give them the benefit of doubt. My dear Deacon, we may disagree and still be brothers in Christ. May God bless your ministry , you are in my prayers.
Mr. Connor, I don’t see anything in Deacon Edward’s comments that suggest a rejection of all vaccines. Many people are concerned about the side effects of pharmaceuticals & especially those created in a hurry.
I really don’t think we’ll have all the answers about Covid for years. And considering it’s possible source, perhaps never.
I was a child myself once (I’m pretty certain all of us were). So was my brother. I remember that by the time we reached school age, both of us were very self-conscious about allowing even our parents to “see us” unclothed! I remember not using the school bathroom all day because there were no doors on the stall (what insanity prompted that policy?!). Both my brother and I were terrified of doctors and nurses who poked and prodded us during examinations–I remember screaming while a doctor examined me. What horrors must these children be experiencing while they are being “examined” and questioned? How does a child feel when a “professional” who has just poked and prodded their bodies announces, with a gentle smile, that the child “feels bad” because they are in the wrong body? Does that make them feel “better?!” Really?! Do they really think, “Thank goodness, this kind doctor has figured out how to help me feel happy again!” Do they even understand the differences between boys and girls at these young ages? How horrible for a child to wake up with sore/painful incision wounds on their private parts–these wounds will require daily wound care!–surely it is an awful experience for these children to have a parent or health care professional touching their body parts that they were always told by parents and teachers are “private!” The mental and psychological trauma caused by these surgeries surely causes any depression and/or anxiety to worsen! And in the meantime, is anyone trying to figure out alternative reasons why a child might feel “sad” all the time? Perhaps it’s because a pet died, or a cherished relative or friend, or perhaps they are anxious because they are watching a scary TV show that their parents are laughing at but that the child is afraid of? Or maybe they are being bullied, not because of their sex, but because bullies are MEAN and often, no teacher is allowed (or has the courage) to confront a bully and put a firm STOP to their violent taunts, threats, and physical attacks. Maybe the child has stomachaches or headaches because of a physical issue–e.g., food intolerance or over/under eating, or maybe the child needs glasses.
What medical professionals are violating their “do no harm” oath when it comes to treating supposedly “trans” children? They should be stripped of their licenses and forbidden to ever be around minor children or teenagers again.
The medical and legal establishment is now monetizing surgical experiments on human beings.
Eighty years ago we fought against fanatics who committed such human experiments, and we put them on trial for crimes against humanity, and hung them for committing these crimes.
I don’t foresee hanging but I do expect to see litigation.
Yes, it is the gist. But in the Nazi concentration camps the victims were unwilling. Now they are willing and it means that humanity hugely advance on its path to a total and “soft” mind control. Imagine some Gypsy woman willing coming to Ravensbrück (women concentration camp) and requesting that she and her daughter will be sterilized. This is exactly what is happening.
There are some cancers that are hormone based. To keep another tumor from happening the patient is given hormone blockers.
Catch 22. Depending on the hormone the patient must have a procedure to rebuild the bone; or else the patient will have osteoporosis.
The big difference is most people who develop a hormone cancer are adults. They are past childbearing years.
Teenagers are to become parents. What are these blockers and replacement procedures doing to all of the organs? When a 30 year old wants to marry and have children but discovers they are sterile. Will they figure out this is a delayed side effect from the trans drugs.
The advent of the contraceptive pill and its acceptance in medical practice represented a fundamental abandonment by the medical profession of the Hippocratic Oath. It was the first time that the profession allowed the deliberate prescription of a substance designed to interfere with normal physiology and function. Early varieties of oral contraceptives caused unexpected complications, most notably venous thrombosis complicated by pulmonary embolism and death. Rather than banning such prescribing, modifications to dosage were tried and tested for no reason other than to allow big pharma the ability to continue making obscene profits – not to care for the needs of women. The outrageous use of gender altering medication and risky surgery to alter the external appearances of normal gender development is in the same category, contrary to the ideals of Hippocratic medicine which sadly continue to be eroded. Worse, of course, is the cooperation of the law, once the great protector of human life in all its forms, in aiding and abetting these abominations through legislation. And where was this abandonment of the ideals of medicine born? In the USA!! God love America – with hands on heart, of course. The Mayo clinic data screams out “Abandon this abomination and affirm its criminality through laws that punish it rather than, as happened with the contraceptive pill, approve, aid and abet it.
Amen! Let’s not forget, however, that one of the biggest cheerleaders for this trans-mania is our devoutly Catholic president, Joe Biden, according to whose word — and how could anyone doubt that? — the pope himself called “a good Catholic” who should continue receiving Communion.
Thank you in advance min.
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