"The serious adverse event reporting is really a key provision because it allows us to just understand a lot more about what's out there and what people are experiencing," Dr. Namandjé Bumpus, chief scientist of the U.S. Food and Drug Administration (FDA), recently said.
You might think Bumpus said this about high-risk drugs, like the abortion drugs mifepristone and misoprostol. After all, the FDA's own label says that roughly one in 25 women who use them will end up in the emergency room.
It would be reasonable to assume that the FDA would want to ensure complications are accounted for so women are fully informed and prepared for the risks. But you'd be wrong. The FDA scientist's statement above is about the chemicals in cosmetics. When it comes to abortion drugs, the FDA has shown an appalling callousness toward women's health and safety, as it no longer requires doctors to track most complications.
This recklessness, outlined in the brief we filed on Thursday with the U.S. Supreme Court, is why we sued the FDA on behalf of doctors and medical associations.
Regardless of one's views on abortion, the fact that the FDA removed the requirements not only for reporting but also for all in-person doctor visits and ongoing care for women taking these drugs should be deeply concerning. Why does the FDA think it's okay for a woman to be left all alone to perform her own abortion without any medical attention or care?
The FDA hasn't always been this reckless with women's health. It originally maintained significant safety standards for women using abortion drugs, including in-person doctor visits to check for ectopic pregnancy, severe bleeding, and life-threatening infections. It made sure that doctors both prescribed the drugs and provided ongoing care to the women using them.
But then—with no rational explanation—the FDA removed these common-sense safety standards, failing American women and jeopardizing their health.
The FDA also violated its stated duty to protect "the public health by assuring the safety, efficacy, and security of...drugs"—a responsibility it doesn't ignore in other contexts.
You can't get through the commercials disrupting your favorite sporting event on television without an ad featuring a drug and then a voice telling you every possible thing that could go wrong and advising you to meet with your doctor before using it. And as much as you may want to get back to your game, this information is a good thing. Americans should always receive information and have the ongoing care of a doctor when taking a high-risk drug.
But the FDA betrayed women and girls by deciding they don't deserve ongoing care or in-person doctor visits when using abortion drugs. The agency has recklessly eliminated the safety standards it once required doctors to provide to women taking these drugs.
And even though the agency admits that its "primary risk management tool is communicating through...product labeling," the FDA and drug companies regularly mislead women into thinking these particular drugs don't come with significant health risks, so women aren't informed to know what to expect and how to prioritize their mental and physical health.
Drug companies and many of the prescribers tout these drugs as being as easy and safe as Tylenol. "They'll just cause a heavy period," companies say (even though the FDA label states that "most patients can expect bleeding more heavily than they do during a heavy menstrual period").
But women's own experiences tell a very different story. Taking these drugs is nothing like having a heavy period. Some women who take them bleed profusely for weeks. They suffer agonizing pain that envelops their bodies as they lie on the floor wondering if they are going to die. Or why they don't have a doctor to check on them.
Still others share stories of not being told that they would be delivering their baby all alone. That they'd have to hold it, pick it up off the floor or out of the drain, and then decide what to do with their child. In tears, they share that they weren't told to see a doctor first to check for ectopic pregnancy or after to check for life-threatening infections. They weren't warned of the anxiety, PTSD, and depression that their experiences would have on their lives. One woman told me, "I've never felt so alone, so betrayed."
But the FDA has turned a blind eye to women's suffering, adamant that women don't deserve even basic care while using these drugs.
The FDA has never acted this recklessly with any other drugs.
But today, when these abortion drugs are mailed to women without even one in-person doctor visit, the prescribers pocket the money and wipe their hands clean, leaving women and young girls to deliver their babies all alone with no ongoing care or support from their doctor.
It's time for the FDA to stop shirking its duty. Women's health matters, and it's time for the FDA to put women first.
Kellie Fiedorek is senior counsel and director of government affairs with Alliance Defending Freedom (@ADFLegal).
The views expressed in this article are the writer's own.
Uncommon Knowledge
Newsweek is committed to challenging conventional wisdom and finding connections in the search for common ground.
Newsweek is committed to challenging conventional wisdom and finding connections in the search for common ground.
