FDA dangerously keeps attacking US women’s reproductive rights

By Donald A. Collins | 14 August 2019
Church and State

(Credit: madmanmikey / Flickr)

We keep finding outrageous examples of FDA overreach in finding safe fertility control methods illegal. There is a long and successful history of use for the 2 pill abortion method which is now used by a substantial number of women here in the US. Go to this web site and find out the specifics: https://safe2choose.org/abortion-pills/using-mifepristone-and-misoprostol/

Here are three stories from highly reputable media outlets you can read which prove my point about the FDA’s actions!

Having been screwed myself by this agency, I am not surprised by its performance which endangers women every day.

No one seems to have the courage to sue the agency to redeem their right to achieve early abortions safely and in the privacy of their own homes.

Start here for number one: The Challenges of innovating access to abortion by Sue Halpern on March 6, 2019.

Although the five states in the TelAbortion trial have some of the most accommodating abortion laws in the country, Gynuity is only able to run the trial with a waiver from the F.D.A., which has put onerous restrictions on the distribution of abortifacients. Mifeprex, the trade name of mifepristone, is one of only seventy-five F.D.A.-approved medications (out of thousands) controlled through its Risk Evaluation and Mitigation Strategy (REMS), and only one of fifty with its most stringent restrictions. According to the F.D.A., REMS, which regulates such drugs as Clozapine, an antipsychotic medication, and Thalidomide, which is known to cause birth defects, is a drug-safety program for “medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.” The REMS mandates that Mifeprex only be dispensed to a patient in a clinic, medical office, or hospital. A doctor can’t send a patient to her local pharmacy with a prescription for the medication, because pharmacies are not allowed to carry it. This limits the ability of physicians to administer the medication and of patients to obtain it, despite nearly twenty years of evidence demonstrating its safety and efficacy, which is why the American Congress of Obstetricians and Gynecologists has recommended eliminating the REMS altogether. An F.D.A. panel of experts recommended eliminating one aspect of the REMS in 2016 when the Mifeprex REMS came up for review. It was overruled by the F.D.A. commissioner, an Obama appointee.

In 2017, the American Civil Liberties Union sued the F.D.A. over the REMS on behalf of the California Academy of Family Physicians; the Society of Family Planning; Pharmacists’ Planning Services, Inc.; and Dr. Graham Chelius, the chief of staff at Kauai Veterans Memorial Hospital, who is the named plaintiff. “While many of my patients have much-wanted pregnancies, a substantial percentage choose to end their pregnancies and come to me seeking abortion care,” he wrote in his sworn testimony. “Most of these women are medically eligible for the FDA-approved medication abortion regimen.” The problem, according to Chelius’s lawyer at the A.C.L.U.’s Reproductive Freedom Project, Julia Kaye, is that the REMS makes this impossible because “rather than writing a prescription for the patient to fill at a retail pharmacy, you have to get multiple layers of approval. It has to go through the pharmacy therapeutics committee and you may need the chief resident to sign off and the nursing committee and all the way up to the chief medical officer.” As Chelius wrote in his testimony, “If I were to comply with the Mifeprex REMS, I would be doing more than just supporting access to abortion in my individual professional capacity. I would also have to involve, and win the approval of, multiple colleagues and staff members in the process of procuring, stocking, dispensing, and billing for Mifeprex.” For Dr. Chelius, who practices in a small, tight-knit community, there are also privacy concerns. Almost everyone knows someone who works at the hospital. He is also concerned for his and his family’s safety.

As the A.C.L.U. lawsuit wends its way through the legal system, Republican members of Congress, the President, and a number of state legislatures continue to whittle away at the constitutional right to abortion established by Roe v. Wade. In late February, the Trump Administration said that it would eliminate family-planning funding for organizations that refer patients to abortion services. A few days later, legislation introduced by Senate Republicans which would have placed criminal liabilities on doctors who failed to save the lives of babies born alive during abortions was narrowly defeated. (Opposition to so-called late-term abortion has become a public relations strategy of anti-abortion advocates—most recently, Donald Trump accused pro-choice Democrats of encouraging infanticide—even though third-trimester abortions are extremely rare and live-birth abortions even rarer.)

Meanwhile, a number of state legislatures are passing laws to ban abortions in the event that Roe is overturned by the Supreme Court, while simultaneously making them increasingly difficult to obtain: more than four hundred new abortion restrictions have been passed since 2011. An Iowa law, which was struck down at the beginning of the year, sought to ban abortions as soon as a fetal heartbeat could be heard, sometimes as early as six weeks, before many women know they are pregnant. Arkansas passed a comparable law, in 2013, that was also struck down, but other states—Florida, Kentucky, and Missouri among them—are considering similar bans. There are now six states—Mississippi, Missouri, North Dakota, South Dakota, Kentucky, and West Virginia—with only a single abortion provider. In states like Texas, where the number of abortion clinics has been halved, some women have to travel up to three hundred miles to a clinic and then are forced, by law, to wait twenty-four hours after their first appointment before receiving an abortion.

Medical abortion should make access easier, but some of the more recent state restrictions also make getting abortifacient drugs, which are already constrained by the REMS, more difficult. Seventeen states require that a clinician be physically present when the mifepristone is taken. Thirty-four states require those clinicians to be licensed physicians. Women who obtain and self-administer abortifacients outside the traditional medical establishment, typically from an Internet pharmacy, may be subject to arrest and imprisonment. In 2013, a woman in Pennsylvania who had ordered them online for her teen-age daughter was sentenced to a nine-to-eighteen-month jail term for “providing abortion without a medical license, dispensing drugs without being a pharmacist, assault and endangering the welfare of a child.” It is now possible to order these medications through Aid Access, a program overseen by a doctor in the Netherlands. So far, no one has been arrested, but the promulgation of fetal-homicide laws—thirty-eight states now have them—and aggressive prosecutors puts women at risk of arrest if they obtain them this way. According to the Guttmacher Institute, “these laws are even being used to pursue women who are merely suspected of having self-induced an abortion but in fact had suffered miscarriages.”

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Start here for the 2nd example: “Abortion Pills Should Be Everywhere” by Farhold Manjoo on August 4, 2019.

Mr. Manjoo begins by saying, “One afternoon about a year ago, just as the Senate began considering Brett Kavanaugh’s nomination to the Supreme Court, I logged on to Day Night Healthcare, an online pharmacy based in India, and ordered a pack of abortion pills. A few hours later, I got a call from a Day Night customer-service agent with a warning. If my credit-card company called to ask about the purchase, ‘tell them you approve the charge, but don’t say what it’s for,’ the man advised. ‘If they ask, say it’s gym equipment, or something like that.’”

Nothing came of this threat and Manjoo’s then notes, “The drugs, which have been used by tens of millions of women around the world, are also some of the safest known to modern medicine — mifepristone has accumulated a record of adverse complications lower than that of Tylenol, Flonase, Xanax and Viagra. In 2017, Canadian regulators lifted most restrictions on the drug, allowing it to be prescribed by any doctor, without requiring an ultrasound, and dispensed in any pharmacy.”

Clearly, enforcement by the FDA will not be effective. As Manjoo tells us,

But in the United States, the Food and Drug Administration has imposed severe limits on mifepristone’s distribution. It can be prescribed only by doctors who meet certain qualifications, and can be dispensed only in clinics licensed to provide abortions, not retail pharmacies.

Yet thanks to the digital handiwork of an emerging faction within the global reproductive-rights movement, restrictions on abortion pills are becoming increasingly difficult to enforce. Despite the F.D.A.’s restrictions, activists have created a robust online market that makes getting pills surprisingly easy. There are “report cards” on where to find tested drugs, detailed guides on how to use them safely, a help line for consulting with legal experts, and dozens of discussion boards and support groups helping women navigate the fraught decision of whether and how to terminate a pregnancy.

Amid growing restrictions on clinic-based abortions, the online pill market functions as a haven of last resort for desperate women. “The women who come to us don’t have any other alternatives,” said Rebecca Gomperts, a Dutch physician and founder of Aid Access, which offers abortion pills online for about $90, with discounts for patients in financial straits. “They don’t have funds, or they are six hours away from the clinic, or they don’t have transport, they have small kids, they live in cars, there are situations of domestic violence — it’s just really bad situations.” In 2018, Gomperts prescribed the drug online to 2,581 patients.

This FDA attitude really resonated with me as an organization I founded International Services Assistance Fund (ISAF) began trying to get a safe, non-surgical method of female sterilization called QS or quinacrine sterilization approved for a Phase III trial. After years of scientific submissions by top experts, the FDA declined to allow a Phase III US trial in December 2016. You can judge whether the same ideological spin was behind its decision only by a review of ISAF’s web site, which is now available here.

However, the historical record of QS use shows it is safer than Viagra. QS administered by using the inserter method has caused no deaths and no life-threatening complications after use for over 40 years by over 200,000 women located in over 50 countries around the world. And yet, the request from ISAF to perform a Phase III trial of QS was denied in spite of the science showing QS does not cause cancer or any serious complications.

If available around the world QS could offer millions of women the option of ending childbirths permanently at an economical cost. Again the FDA’s action in denying even a Phase III trial is highly suspect and we feel it has been proven wrong by the research you can view on the QS site. FDA’s actions in trying to stop making safe medical abortions more accessible simply underlines the point made here on QS.

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Start here for the 3rd example: New York Woman Faces Up to Eight Years Behind Bars for Selling Abortion Pills Online by Imani Gandy on August 9, 2019.

Given the anti-choice success in reducing abortion access, some pregnant people have turned toward self-managed abortion care to terminate their pregnancies. Many pregnant people prefer self-managed care, especially if don’t feel safe going to abortion clinics—perhaps, for example, because of their gender identity or immigration status—or if they cannot take the time required to comply with various state regulations, like waiting periods and mandatory counseling and ultrasounds.

Wing launched a separate website in May 2016 and sold medication abortion kits there for $85 with expedited shipping. Medication abortion is a non-surgical procedure that involves a pregnant patient taking two drugs. The first drug, mifepristone, works by blocking the hormone progesterone, which causes the lining of the uterus to break down so that the pregnancy cannot continue. The second drug, misoprostol, which causes cramps and heavy bleeding that usually lasts for a few hours, induces contractions and ends the pregnancy.

Medication abortion in a clinical setting costs anywhere from $400 to $1,000, depending on one’s health insurance (or lack thereof), the state, and the provider. Some overseas suppliers, meanwhile, can charge upward of $350 for medication abortion kits. But Wing bought the pills in bulk from India and marked them up 100 percent. This, in her view, was more than enough.

A year later, in February 2019, FDA agents showed up at Wing’s door with an arrest warrant and seized her computer and phones, her daughter’s iPad, boxes of medication abortion pills, and a dozen packages that she was set to mail.

After several months of awaiting her fate, Wing was indicted on June 26. The indictment alleges that from June 2016 through June 2018, Wing conspired to defraud the United States by impeding lawful functions of federal law enforcement and regulatory agencies, and that from January 2018 through February 2018, Wing caused the introduction of unapproved, misbranded prescription drugs mifepristone and misoprostol into interstate commerce by sending the drugs from the state of New York to Wisconsin.

The indictment further alleges that Wing “illegally smuggled into the United States misbranded prescription drugs from India, which were not approved by the Food and Drug Administration (FDA) for distribution in the United States, and that she sold these misbranded prescription drugs to customers in the United States and around the world” and that she dispensed these prescription drugs without a valid license to do so.

There isn’t much precedent for this sort of thing. As Chelsea Conaboy notes for Mother Jones:

A New Jersey man was indicted in 2015 for importing and distributing prescription drugs, primarily erectile dysfunction pills but also mifepristone and misoprostol, but he died before the case was resolved. In 2010, a Virginia doctor who bought pills from a Chinese distributor to send to a family planning clinic in Mexico was sentenced to a one-year probation and fined $1,000.

People have, however, been prosecuted for self-managing their abortions. According to a report by If/When/How, since 1973, at least 21 people have been arrested for self-induced abortions in 20 states. They include Jennie Linn McCormack and Jennifer Whalen, who bought or were suspected of buying abortion pills online. McCormack’s case was dismissed, and Whalen served time in prison. And then there’s the egregious case involving Purvi Patel, who purchased abortion pills online and was sentenced to 41 years in prison for feticide and neglect of a dependent before a judge overturned her conviction, stating that she had already served enough time.

We encourage all women to write to the FDA asking why they fall into an ideological position which denies the science and endangers women. These disgustingly dangerous examples of misuse of power make it ever more important to regain control of an agency which apparently has lost its morality as well as its proper function as an institution chartered to ensure human needs are provided for safely.

Former US Navy officer, banker and venture capitalist, Donald A. Collins, a free lance writer living in Washington, DC., has spent over 40 years working for women’s reproductive health as a board member and/or officer of numerous family planning organizations including Planned Parenthood Federation of America, Guttmacher Institute, Family Health International and Ipas. Yale under graduate, NYU MBA. He is the author of From the Dissident Left: A Collection of Essays 2004-2013.

From the Dissident Left: A Collection of Essays 2004-2013

By Donald A. Collins
Publisher: Church and State Press (July 30, 2014)
ASIN: B00MA40TVE
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