April 12, 2023
The lawsuit started in November when the Alliance for Hippocratic Medicine challenged the FDA’s approval of the chemical abortion drug regimen of mifepristone and misoprostol. In the initial complaint, the alliance pointed out that the FDA didn’t do the required testing and ignored citizen petitions for more than 16 years, all while catering to abortion organizations such as Planned Parenthood and abortion drug manufacturers. Then in January, Danco Laboratories, the secretive offshore operation that manufactures chemical abortion drugs, filed to intervene in the case on behalf of the FDA...
So, the emergency room doctors, OB-GYNs and pediatricians who filed suit are up against two bureaucratic strongholds: a wealthy, secretive chemical abortion drug company and the federal government, which have, in this instance, joined forces in placing profits and politics ahead of protecting Americans from harmful drugs...
Just as the FDA ignored the harms of opioids, it has refused to acknowledge the harms of chemical abortion drugs. Chemical abortions have a complication rate of four times that of surgical abortions. At least 20% of women who use chemical abortion drugs will have to seek medical help afterward. The adverse effects of the drugs range from hemorrhage to severe infection to the inability to have future successful pregnancies.
With its initial approval of these drugs, the FDA ignored these adverse effects. It cut corners on testing and released the drugs for wide use, ignoring that the few studies it did consult incorporated commonsense protections for women who take the drugs, like requiring an ultrasound to determine gestational age and requiring multiple in-person appointments during the drug regimen.
The FDA never required ultrasounds and has since ceased to require even a single in-person doctor visit...
In response to this reasonable request from concerned citizens, the FDA did nothing. For 14 years, the agency ignored the citizen petition. Then in 2016, the FDA denied the petition, and on the very same day, it dropped some of the few safeguards in place on chemical abortion drugs — at the request of Danco Laboratories.
In 2019, citizens gave the FDA another chance. AAPLOG submitted a second citizen petition, asking the agency to strengthen and restore the safeguards it had eliminated at the behest of Danco. Instead, the FDA approved a generic version of mifepristone for use one month later.
In 2021, the FDA began allowing women to receive chemical abortion drugs by mail, eliminating the safeguard of in-person interaction with an abortion provider. The FDA based this change on a lack of reported adverse effects in the past few years — neglecting to mention that, in 2016, it had eliminated reporting requirements for nonfatal adverse effects.