As an OB/Gyn, I would like to understand why the American College of Obstetrics and Gynecology (ACOG) came out against the ruling in Texas by Judge Matthew Kaczmarek regarding Mifepristone in Alliance for Hippocratic Medicine vs. FDA. ACOG says it is safe and effective in all their talking points, and it says that it is healthcare. According to Webster’s Dictionary, healthcare is “the maintaining and restoration of health by the treatment and prevention of disease especially by trained and licensed professions.”

 

Everything in quotes below is directly from the District Court ruling:

 

“Pregnancy is a normal physiological state most women experience one or more times during their childbearing years — a natural process essential to perpetuating human life. Defendants even admit pregnancy is not an ‘illness.’ FDA claims the Final Rule explained Subpart H was available for serious or life-threatening ‘conditions,’ whether they were understood colloquially to be ‘illnesses.’ (ECF No. 28 at 36). But the Final Rule says no such thing. ‘One comment asserted that neither depression nor psychosis is a disease, nor is either one serious or life-threatening….’”

 

Pregnancy is not a disease, so why does ACOG think ending it is healthcare?

 

“…the U.S. trials FDA relied upon when approving mifepristone required that: (1) each woman receive an ultrasound to confirm gestational age and exclude an ectopic pregnancy; (2) physicians have experience in performing surgical abortions and admitting privileges at medical facilities that provide emergency care; (3) all patients be within one hour of emergency facilities or the facilities of the principal investigator; and (4) women be monitored for four hours to check for adverse events after taking misoprostol. (ECF No. 7 at 23). However, FDA included none of these requirements — which were explicitly stated in the clinical trial FDA relied on most — in the 2000 Approval. Likewise, FDA’s 2016 Changes omitted the requirements of the underlying tests: (1) gestational age confirmed by ultrasounds; (2) participants required to return for clinical assessment; and (3) surgical intervention if necessary.”

 

Why take away these protections? The ruling argues that the U.S. Food and Drug Administration (FDA) did not satisfy the correct procedures when authorizing Mifepristone. It did not answer the concerns about adverse events until the change in the requirements 16 years later:

 

“Once citizen petitions are submitted, the FDA Commissioner is required to respond in one of three manners ‘within 180 days of receipt of the petition.’” (quoting 21 C.F.R. § 10.30(e)(2)).”

 

“It took FDA 13 years, 7 months, and 9 days to respond to the 2002 Petition. FDA then moved the goalposts by substantially changing the regulatory scheme on the same day it issued its Response. And it took FDA 2 years, 8 months, and 17 days to respond to the 2019 Petition which challenged those changes. Thus, in the 20 years between the 2002 Petition and the filing of this suit, plaintiffs were waiting on FDA for over 16 of those years. (See Hill Dermaceuticals, Inc. v. U.S. Food & Drug Admin., 524 F. Supp. 2d 5, 9 D.D.C. 2007)…”

 

The concerns expressed in the two citizen petitions were about adverse events women and girls experience when taking chemical abortion drugs. Why was this drug approved under Subpart H?

 

“This reading is also consistent with the fact that aside from mifepristone, FDA had approved fewer than forty NDAs under Subpart H by early 2002. (See id. at 20). And of those other approvals, twenty were for the treatment of HIV and HIV-related diseases, nine were for the treatment of various cancers and their symptoms, four were for severe bacterial infections, one was for chronic hypertension, and one was for leprosy. ‘One of these things is not like the others, one of these things just doesn’t belong.’ See Sesame Street.”

 

“The standard for reopening is satisfied here. FDA’s requirements for distribution in its 2000 approval originally included:

• In-person dispensing from the doctor to the patient;
• Secure shipping procedures;
• Tracking system ability;
• Use of authorized distributors and agents; and
• Provision of the drug through direct, confidential physician distribution systems that ensures only qualified physicians will receive the drug for patient dispensing.

 

“FDA’s 2016 Changes to this regulatory scheme included the following alterations:

• Extending the maximum gestational age at which a woman or girl can abort her unborn child from 49 days to 70 days;
• Altering the mifepristone dosage from 600 mg to 200 mg, the misoprostol dosage from 400 mcg to 800 mcg, and misoprostol administration from oral to buccal;
• Eliminating the requirement that administration of misoprostol occur in-clinic;
• Broadening the window for misoprostol administration to include a range of 24–48 hours after taking mifepristone, instead of 48 hours afterward;
• Adding a repeat 800 mcg buccal dose of misoprostol in the event of incomplete chemical abortion;
• Removing the requirement for an in-person follow-up examination after an abortion;
• Allowing “healthcare providers” other than physicians to dispense and administer the chemical abortion drugs; and
• Eliminating the requirement for prescribers to report all non-fatal serious adverse events from chemical abortion drugs.”

 

How do these changes safeguard women? Extending the gestational age during which Mifepristone may be utilized without requiring ultrasound is not safe for women. ACOG even says 40 percent of pregnancies are miss-timed. Not requiring an ultrasound fails to protect women with ectopic pregnancies and improperly allows the use of the medication at an unsafe gestational age.

 

The District Court opinion continues:

 

“FDA has also reported at least ninety-seven cases where women with ectopic pregnancies took mifepristone. But these data are likely incomplete because FDA now only requires reporting on deaths.

 

“[Another] study noted 20 deaths, 529 life-threatening events, and 1,957 severe adverse events before concluding that a pre-abortion ultrasound should be required to rule out ectopic pregnancy and confirm gestational age.”

 

What about the issue of informed consent? Can informed consent really be obtained over the internet?

 

“To obtain informed consent, physicians must ‘[a]assess the patient’s ability to understand relevant medical information’ and present to their patient ‘relevant information accurately and sensitively,’ including the burdens and risks of the procedure.”

 

Not to mention that mailing Mifepristone is clearly against the law.

 

“The Comstock Act declares ‘[e]very obscene, lewd, lascivious, indecent, filthy or vile article, matter, thing, device, or substance’ to be ‘nonmailable matter’ that ‘shall not be conveyed in the mails or delivered from any post office or by any letter carrier.’ (18 U.S.C. § 1461). The next clauses declare nonmailable ‘[e]very article or thing designed, adapted, or intended for producing abortion, or for any indecent or immoral use; and [e]very article, instrument, substance, drug, medicine, or thing which is advertised or described in a manner calculated to lead another to use or apply it for producing abortion, or for any indecent or immoral purpose.’ Similarly, Section 1462 forbids the use of ‘any express company or other common carrier’ to transport chemical abortion drugs ‘in interstate or foreign commerce.’”

 

Comparing chemical abortion to surgical abortion:

 

“Lastly, chemical abortion does not ‘treat patients unresponsive to, or intolerant of, available therapy.’ (See 21 C.F.R. § 314.500.) ‘To the contrary, because ‘medical abortion failures should be managed with surgical termination’ the option for surgical abortion must be available for any Mifeprex patient.’ (ECF No. 1-14 at 23 quoting the Mifeprex “Warnings” label). One study showed that 18.3 percent of women required surgical intervention after the chemical abortion regimen failed. Hence, ‘any patient who would be intolerant of surgical abortion, if such a class of patients exists, cannot use the Mifeprex Regimen.’  On balance, the data reflect little to no benefit over surgical abortion — much less a ‘meaningful therapeutic’ benefit.”

 

One final quote from the District Court ruling:

 

“The entire abortion process takes place within the mother’s home, without physician oversight, potentially leading to undetected ectopic pregnancies, failure of rH factor incompatibility detection, and misdiagnosis of gestational age — all leading to severe or even fatal consequences. Contrary to popular belief and talking points, the evidence shows chemical abortion is not ‘as easy as taking Advil.’”

 

I would challenge ACOG to not just go around saying its safe and effective but care about what this drug does. Quit being a blind supporter of abortion and change to care about the lives of women.

 

Women’s lives are at stake.