Medical experts are continuing to sound the alarm about the health dangers of the abortion pill in the wake of the Food and Drug Administration’s (FDA) approval of the generic version of the drug last week.

The surprise approval that was quietly issued on September 30 now gives the green light to three American companies to produce a generic form of mifepristone, the abortion drug that blocks the pregnancy hormone progesterone from reaching an unborn child, which eventually starves the baby and causes its death. The move came as a shock to conservatives, as just a week earlier, Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary stated that they would consider restoring restrictions on the drug in light of “recent studies raising concerns about the safety of mifepristone as currently administered.”

FDA spokesman Andrew Nixon characterized the approval of the generic form of mifepristone as an inevitable decision based on a routine federal review. “[T]he FDA has very limited discretion in deciding whether to approve a generic drug,” he stated. “By law, the Secretary of Health and Human Services must approve an application if it demonstrates that the generic drug is identical to the brand-name drug.” But lawmakers like Senator Josh Hawley (R-Mo.) are skeptical of that explanation. “[The] application for this new drug has been pending for four years,” he pointed out during “Washington Watch” last week. “Joe Biden’s FDA didn’t approve it. The FDA is supposed to be doing a safety study of the chemical abortion drug. And rather than [do] that, they just approved a new one.”

Meanwhile, use of the abortion pill has exploded over the last several years, now accounting for almost two-thirds of all abortions carried out in the U.S. and largely blunting the impact of the 2022 Dobbs Supreme Court decision that overturned Roe v. Wade. The spread of the abortion drug comes as studies continue to reveal the serious dangers that the pill poses for women’s health. A study released in April by the Ethics & Public Policy Center found that almost 11% of women who take the abortion pill “experience sepsis, infection, hemorrhaging, or another serious adverse event within 45 days.” The results mirror a host of other data, including a Finnish study finding that women who take the abortion pill are nearly four times more likely to experience severe complications than women who undergo surgical abortions.

Physicians like Dr. Roger Marshall, who currently serves as a Republican senator representing Kansas, say they are demanding answers from the FDA.

“This is disturbing news from the FDA,” he emphasized during “This Week on Capitol Hill” over the weekend. “I never, of course, prescribed those pills, but I took care of the complications. So women would go to Wichita, get these pills prescribed, they’d come back and, lo and behold, they’re having complications. About 11% of women have complications from this. … [H]emorrhaging, infection, sepsis are the three main problems, and what no one tells them is they’re going to have a lot of pain and cramping as well. So it is very concerning what’s going on, and certainly I’m asking the FDA to step up this review process.”

Marshall, who delivered over 5,000 babies during a 25-year career as an OB-GYN, went on to point out that mifepristone has become a singularly dangerous drug due to the lack of restrictions when it’s prescribed.

“There’s no other drug out there that would be allowed to be prescribed without a doctor seeing them in person, a drug with as many side effects,” he noted. “The abortion industry came in under Joe Biden and allowed this to be prescribed like candy, without seeing a doctor in person. Here’s my concern. So beyond just the side effects of this drug, women are typically off a month on their dates [for] how far along they are. The further you are along in this pregnancy, the bigger chance of the drug failing to cause the abortion. These are category X drugs [that] cause significant fetal anomalies fairly commonly. … [That’s] one more reason why we need to demand an ultrasound be done before these abortion pills are prescribed. … [T]oday I’ve got my phone calls out to the FDA and asking ‘What’s happening here?’”

Marshall concluded by urging the public to demand answers from the administration on why it has failed to act to reestablish guardrails for dispensing the drug.

“[W]e would like to think that President Trump has been the most pro-life president we’ve ever seen,” he observed. “Thank goodness for the Supreme Court nominees that he was able to appoint. … But this policy is something that needs to be addressed by the administration. And I’ve been patient. … I really think we need to take the next couple of weeks. [The public], all of our friends up here on Capitol Hill, need to put pressure on FDA to say, ‘What is going on with this?’ Why are we allowing this drug to be prescribed without an in-person visit with the physician, as well as an ultrasound being done? This is not candy that they’re handing out. This is a serious drug with potentially life-threatening complications.”