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Rita Joseph's avatar

Here's the anatomy of this real scandal. Back in 2000, the FDA was manipulated into abandoning the thoroughness of its standard safety investigation regime.

It adopted instead the accelerated approval for emergency medications which had been introduced in the nineties to fast-track new experimental drugs to deal with, inter alia, the alarming HIV/AIDS outbreak.

The sponsors of the abortion pill, the Population Council and Danco, the manufacturers, opportunistically jumped on the expedited bandwagon.

The FDA, under political and media pressure, reneged on its duty of care and claimed an exaggerated emergency need for this drug to be approved. They placed healthy pregnancy in the same emergency basket as the AIDS epidemic. The usual careful regimen was rashly hurtled through this newly instituted “priority review” process.

Research history on Mifepristone drug—inadequate information

Take a look at some of the mistakes made.

1. In 1996, the Population Council filed a new drug application for mifepristone with FDA. The real result, after four years of review following the proper protocols, was a thumbs down—the drug’s distribution could not be declared safe. This result, recorded in a letter, dated February 2000, to the Population Council (the chief advocate for this abortion pill) stated that

“adequate information has not been presented to demonstrate that the drug, when marketed in accordance with the terms of distribution proposed, is safe and effective for use as recommended.”

2. On June 1, 2000, FDA sent another letter to the Population Council setting out proposed restrictions to address serious safety issues. Doctors were to be “trained and authorized by law” to perform surgical abortions. Doctors needed training in administering mifepristone and treating adverse events; and doctors were to have “continuing access (e.g., admitting privileges) to a medical facility equipped for instrumental pregnancy termination, resuscitation procedures, and blood transfusion at the facility or [one hour’s] drive from the treatment facility.”

3. “When FDA’s proposal was leaked to the press, a political and editorial backlash ensued.” (Kacsmaryk)

4. “In response, the Population Council rejected the proposal and repudiated the restrictions the sponsor itself proposed in 1996 — what FDA deemed a “very significant change” in the sponsor’s position. Because “[t]he whole idea of mifepristone was to increase access,” abortion advocates argued that restrictions on mifepristone “would effectively eliminate” the drug’s “main advantage” and would “kill[] the drug.” (Kacsmaryk)

5. Only a few months later, in September 2000, FDA reneged on its safety proposals and gave in to the objections of the Population Council and Danco. Despite its “serious reservations” about mifepristone’s safety, FDA “concluded that there was no need for special certification programs or additional restrictions.”

6. In September 2000, FDA’s February assessment earlier that year was abandoned—replaced with a set of safety precautions that waived the requirement for assessment of the safety and effectiveness of the Misopristol on pediatric patients.

“Be advised, as of April 1, 1999, all applications for new active ingredients, new dosage forms. new indications, new routes of administration, and new dosing regimens are required to contain an assessment of the safety and effectiveness of the product on pediatric patients unless this requirement is waived… We are waiving the pediatric requirement for this action on this application. “

Sixteen years later, in 2016, safety precautions adopted originally in lieu of “adequate information” originally demanded by the FDA were further relaxed.

In 2021, safety precautions were so relaxed that Mifepristone could be sent through the post to be self-administered.

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