Agency abandoned its responsibility to protect Americans’ health and well-being
Last Friday, a federal district court in Texas ruled that the Food and Drug Administration overstepped its authority with its 2000 approval of chemical abortion drugs. The ruling is a welcome reminder that the FDA exists to serve the American people, not the abortion lobby.
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.
Danco Laboratories isn’t your average pharmaceutical company. In fact, it is barely a pharmaceutical company at all. Danco exists to manufacture just one drug: the chemical abortion drug known as RU-486, or mifepristone. From the beginning, its activities have been shrouded in secrecy. Though chemical abortion drugs have earned tens of millions of dollars over the years, offshore bank accounts and anonymous investors make it nearly impossible to trace where the money has gone. Even leftist sources like Mother Jones can’t help but raise an eyebrow at Danco.
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.
Congress created the FDA to serve as the nation’s gatekeeper of legal drugs by preventing unsafe products from entering the market. But in 2000, when the FDA approved mifepristone and misoprostol, it failed in that duty. Fortunately, the court in Texas agreed.
This is not the first time the FDA has ignored its responsibilities and exposed everyday Americans to harm. In 1995, under pressure from drug manufacturer Purdue Pharmaceuticals, the Clinton FDA approved the narcotic OxyContin for wide use — severely lacking the necessary testing. Under more pressure, it approved fentanyl three years later. In 2017, the government declared opioid addiction a public health emergency, and in 2021, the most recent year for which records are available, 136 Americans died every day from an opioid overdose.
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 2000, under pressure from the Clinton administration, the FDA forced the approval through by claiming — falsely — that chemical abortion drugs offer “meaningful therapeutic benefit” and wrongly labeling pregnancy a “life-threatening or serious illness.”
The American Association of Pro-Life Obstetricians and Gynecologists and the Christian Medical & Dental Associations spoke up, filing a citizen petition in 2002 that challenged the FDA’s initial approval and asked the FDA to complete the studies it had neglected to perform, including the pediatric studies. The citizen petition asked that these dangerous drugs’ approval be withdrawn until the FDA did its job.
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.
Finally, in 2022, the FDA denied the substance of the 2019 citizen petition.
The FDA has made it clear that it cares more about what’s good for the abortion industry than what’s good for everyday Americans. Now, finally, the federal judiciary is requiring the FDA to do its job: work for the health and well-being of Americans.
Source – https://washingtontimes.com/news/2023/apr/12/ending-fdas-ugly-alliance-with-big-abortion/