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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I’m sorry but the bishops don’t get to weigh in on our immigration crisis because they all share in the guilt of encouraging people to break the law by entering the USA illegally. And, in addition to that, the bishops profitted handsomely by this conspiracy to abet foreigners’ breaking our laws.
I’d suggest that Bishop Broglio try leaving the USA or entering any other country without a passport i.e. illegally and see what the consequences are.
Excellent point, Diogenes.
The bishops have blood on their hands. They have advocated for the illegal migration of millions into this country, which directly resulted in the deaths of thousands upon thousands of Americans due to drug overdoses, plus the sex trafficking of women and children.
Archbishop Broglio and his USCCB henchmen are complicit. It’s just one part of the legacy of Bergoglio.
(Also see: Rupnik, et al.)
I don’t believe the bishops see all sides of the border security issue, especially the tragic effects it’s had on Mexican communities plagued by cartel violence & extortion .Human smuggling just strengthens the cartels through profits & enables turf wars.
On the other hand, some who only see enforcing immigration law as a good in itself can miss the human suffering of those who are taken away from their work in our hotels, landscaping companies, & poultry processing plants. Most of these are otherwise decent folk who are trying to support their families back home & doing jobs many US citizens don’t want.
mrscracker, I do see your point about people wanting to come here to seek jobs and support their families. At the same time, how many of these people are holding jobs that are ‘off-the-books’ and are being paid slave wages? How many in the agriculture industry are picking crops and living in trailers moving from place to place as the seasons change- a totally peripatetic existence? How many jobs come with Workman’s Comp and health insurance? How many have fraudulently obtained drivers licenses and Social Security cards and then illegally vote in our elections as instructed by the DNC?
Let me tell you about someone I counseled in my Psychology practice a few years back. He came to the USA illegally and had to pay a huge sum of money to the cartel that guaranteed his safe passage. At first he was sending a good deal of the money he earned back to Mexico to support the wife and three children he left there. After he was here for a time, he began feeling lonely and he met an Hispanic woman who I guess sensed that he was a hard working guy and a good catch. She got pregnant. Now they are living together and the money he used to send back home stopped because few salaries can support two families. My guess is that his wife and three children are even more destitute than before, the children will be forgotten and will remain fatherless for their lives. Multiply this scenario hundreds of thousands of times. Illegal immigration is not only a crime; in my book it is a sin.
Yes, it certainly creates all kinds of opportunities for abuse & exploitation. That’s why I think we should try to normalize the immigration/work visa status for folks who are employed in our communities & have maintained clean records. It would also allow them to go home & visit their families on a regular basis instead of being stuck here & taking up with new partners.
The real criminals need to be deported ASAP but decent workers are an asset we shouldn’t take for granted. We’ll be competing soon with other nations for workers as our population ages.
I worked for years & years with no health insurance or benefits. Lots of people here live in trailers, not just Hispanic migrants. Agricultural workers are generally legal. I’ve heard that fewer Mexicans want those kinds of jobs these days. Mexico’s no longer a 3rd World nation but there are still pockets of poverty.
I think the bishops see the human suffering without balancing that with the terrible price Mexico pays for our enabling the cartels. The border needs to be secured & the smuggling ended as much as possible. But we can work with people already in the workforce & not try to channel Inspector Javert. There should be a legal, humane & reasonable solution.
Bishops have been paid for “resettlement”.
I am a CPA, if I have any interest in a potential audit client, I may not opine on their financial statements. Why? Because my independence is impaired.
Same here.
Every illegal has a criminal history.
There is a bizarre notion among invasion advocates that somehow if somebody enters illegally, that “laying low” exonerates, excuses or mitigates their illegal entry. I assure you that if you commit tax fraud, the IRS will not defer prosecution simply because you haven’t followed up your initial evasion with another.
This is CCC 2241.
Catechism of the Catholic Church 2241:
The more prosperous nations are obliged, to the extent they are able,
(We are no longer able to do so. We are “broke”. There are cultural and economic reasons that impair our ability to receive more-especially millions-even if they all entered legally)
to welcome the foreigner in search of the security and the means of livelihood
(Seeking our welfare state, and the drive by certain industries to maintain subpar wages is not security or means of livelihood)
which he cannot find in his country of origin. Public authorities should see to it that the natural right is respected that places a guest under the protection of those who receive him.
(The operative word here is guest. Guests are respectful of their host, the host’s abode, the host’s needs and do not attempt to become squatters)
Political authorities, for the sake of the common good for which they are responsible, may make the exercise of the right to immigrate subject to various juridical conditions, especially with regard to the immigrants’ duties toward their country of adoption.
(NOTHING is ever said about the responsibilities of the immigrants or those that violate our sovereignty or their duties)
Immigrants are obliged to respect with gratitude the material and spiritual heritage of the country that receives them, to obey its laws and to assist in carrying civic burdens.
(Rioting and insisting on open borders, flying foreign flags and running for office and prioritizing the needs of one’s own tribe, ethnicity, religion or country of origin is NOT respecting with gratitude the material and spiritual heritage of the country that receives them, obedience to its laws or the assistance with carrying civic burdens.) Ilhan Omar should simply not be in any position of authority.
Bishops seem to have forgotten the citizens of this country have rights and reasonable expectations of a government in protecting their rights as well-and they never seem to worry about our concerns in this regard.
I think Archbishop Broglio may be missing important actions of ICE. Incited by Trump’s MAGA insanity, and the complicit Sec. Noem, and Border Czar Homan, having caused uprisings nationwide. What was ICE’s charter? I heard that the order was to seek out criminals, cartels like MS13.
The criminal actions this week by ICE “officers” handcuffing Senator Alex Padilla and New York Comptroller Brad Lander proved that Trump, again, is out of control.
This week, the raids resumed on farms, meat processors, restaurants, and hotels. I have asked some GOP leaders, Senator majority leader, John Barrasso, GOP Whip and Bill Cassidy, why they remain silent. No response. Seems like nothing has changed.
Dear Pitchfork. I agree with most of your hypotheses. As a Catholic, I most always, favor the decisions of the Hierarchy. I try to refrain from disparaging them. The challenged Church needs the help of its faithful.
No question, migration and the asylum overload are the main causes of criminals entering the country. The text makes no mention of ICE and its mission. ICE appears to be thrust onto the scene. They show little compassion even to the migrants working in the fields. There is strong evidence that Trump’s ICE minions have been given free range. Noem and Homan are using a “scorched earth, slash-and=burn methods. Ex: just this week, Senator Alex Padilla and NYC Comptroller Brad Landon were handcuffed and released. ICE seems to be in every city, even my little city of Kingston, NY. I asked my GOP congressional reps “did Congress appropriate taxpayer money to fund ICE?” No reply. I am amazed that my GOP US reps have remained silent on many issues facing the nation.
Criminal and ruthless cartels, Tren de Aragua and MS13 are driving many of the migrants from their countries. They are in the US.
There have been forceful statements from the church.
Thank you
Mr Morgan, no one comes to our border without having paid off the cartels. And not a few migrants remain in debt to them and are extorted into drug smuggling. It’s a really ugly revolving door that we have cooperated with by not securing the border.
I feel sorry for hardworking migrants who are just here to support their parents and families but the bad ones need to go. Hopefully we can fix our system to reward the good workers and make future entry safe and legal.