Pro-Life Action League Files Complaint with FDA over Abortion Pill

A recent Time magazine article about Planned Parenthood’s expansion of telehealth services brought to light some apparently serious deviations from federal safety requirements for mifepristone (also known variously as RU-486, Mifeprex, “medical abortion,” or simply “the abortion pill”). In response, the Pro-Life Action League filed a complaint this week with the U.S. Food and Drug Administration (FDA).

The article, written by Time reporter Abigail Abrams, reads as if it could have been written by Planned Parenthood’s high-priced public relations firm. Not only does Abrams clearly show her hand in favor of relaxing the requirements for mifepristone, but she also fails to include any comment from anyone in the pro-life movement.

Most troublingly, Abrams appears to intentionally mislead the public on the requirements for the dispensing of mifepristone. In the opening paragraphs, Abrams tells of a first responder in New York who had recently found out she was pregnant and wanted an abortion:

So between a busy schedule of helping patients, she made an appointment for Planned Parenthood’s new telehealth service, requested an abortion, and attended an initial counseling session—all while sitting in an ambulance.

Once she completed her virtual visit through the organization’s app, the first responder’s ambulance swung by her local Planned Parenthood clinic so she could pick up the pills needed to end her pregnancy.

According to this sequence of events:

  • There was no mention of verification of pregnancy by testing, examination, or ultrasound. Planned Parenthood merely took the patient’s word for it via telehealth session that she was pregnant (and, presumably, how far along she was).
  • There was no mention of how ectopic pregnancy might have been ruled out.
  • There was no mention of blood draws that would establish hemoglobin levels and Rh status.
  • There was no mention of the patient taking the mifepristone in the presence of Planned Parenthood personnel.

These omissions could give rise to a woman suffering an ectopic pregnancy, experiencing anemia, decreasing the likelihood of carrying a future pregnancy to term, or—most notably—diversion of the pills to someone who may or may not even want an abortion.  (It’s not hard to see why perpetrators of sex trafficking, for example, very much want the abortion pill to be more easily accessible.)

Moreover, these omissions give the reader the impression that medical abortions are extremely safe and need less regulation. In fact, the article says just that:

Doctors can prescribe the medications for an abortion through the app, but patients still have to visit a clinic because the Food and Drug Administration requires that providers distribute mifepristone, one of the drugs commonly used in medication abortions, in person, despite doctors saying this requirement is medically unnecessary.

This is an instance of blatantly irresponsible journalism. In any case, there are three possibilities:

  1. Planned Parenthood is openly defying FDA protocols for medical abortions and bragging about it.
  2. Planned Parenthood is complying with FDA protocols for medical abortions, but no one in a position of authority at Planned Parenthood has read Abrams’ Time article and is thus unaware that she got some key details wrong.
  3. Planned Parenthood is complying with FDA protocols for medical abortions, and despite Abrams’ having gotten some key details wrong, Planned Parenthood is pleased with the article and prefers not to correct the record, because they hope to use it to loosen the FDA’s requirements for mifepristone.

Of these possibilities, we suspect that #3 is the most likely.  If so, the pressure to further deregulate mifepristone will only increase.

In our complaint filed this week, the Pro-Life Action League urged the FDA to hold firm.  Without observation of the ingestion of mifepristone, the road to diversion becomes ever more easily traveled and many women who are pregnant will justifiably have greater fears of having their food or drinks spiked with this human pesticide.

The Pro-Life Action League also urged the FDA to investigate Planned Parenthood Hudson Peconic (the affiliate featured in the Time article) as well as New York-based Danco Laboratories—the sole manufacturer of mifepristone—to determine if Danco is allowing relaxed distribution of the drug in defiance of FDA regulations.

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