EXCLUSIVE: Lifting the Curtain on FDA's Questionable Abortion Pill Approval

The average cost of abortion pills in the United States is $600, plus one life.

Unfortunately, that is a price many women are willing to accept in exchange for cutting motherhood short. But what if they knew their own lives were at risk, too?

Any patient considering taking a new medication has a right to know the full extent of its potential risks. In the case of mifepristone, however, any concerns about the abortion drug's true dangers have been dismissed for 25 years by proponents who claim the FDA conducted a thorough review of its safety.

Yet the Foundation for the Restoration of America's (FFROA) recent study of insurance claims data for chemical abortions show a serious complication rate of about 11 percent—22 times higher than the FDA admits.

At least 648,500 chemical abortions took place in 2023, according to the Guttmacher Institute.

That means more than 70,000 women in the United States likely experienced at least one serious adverse side effect—including hemorrhage, sepsis, or even death—from mifepristone in 2023.

How, then, did the U.S. Food and Drug Administration (FDA) approve such a dangerous drug in the first place?

The agency has long held that its process was fair and apolitical. Others who watched it all unfold say otherwise.

The Consequences of Elections

Practicing physician and former Rep. Dave Weldon (R-FL) was serving out his third term on Capitol Hill when the FDA approved Mifeprex, or brand-name mifepristone, in September 2000.

To this day, he can still recall the outrage he and many of his colleagues felt over federal health officials' apparent decision to put politics ahead of patients' health.

"The normal deliberations of the FDA were short-circuited," Weldon told Restoration News. "It was historic because most drugs have to be beneficial to be approved. Most drugs have to have an acceptable level of side effects to be approved, and this was the first drug that was ever introduced and put in front of the FDA that took the whole safety and benefit equation that the FDA always goes through and flipped it on its head."

The FDA approved Mifeprex through a regulation known as Subpart H, which exists to help expedite the approval of new drugs for "serious or life-threatening illnesses." The provision allows the agency to impose restrictions on such drugs to ensure safe use.

But pregnancy is not a life-threatening illness, noted Weldon, who was up for consideration to lead the Centers for Disease Control and Prevention (CDC) earlier this year.

A staunch advocate for life, Weldon believes abortion is wrong at all stages of pregnancy. He said his stance on the issue is rooted in his Christian faith and the belief that all people are made in the image of God.

"God loves each and every one of us, and I don't think there are disposable people in God's book," he said.

Unfortunately, not everyone agrees.

Weldon recalled how Republicans "protested loudly" against the FDA's decision, proposing remedial legislation and sending letters to administration officials. It was all to no avail.

"The Clinton administration moved ahead. And that's the consequences of elections," he said.

(READ MORE: Planned Parenthood Takes Another Hit for Deceiving Women About Abortion Pills)

FDA Claims Neutrality

The FDA has long held that its approval of Mifeprex was free from political influence.

In an April 2023 interview with Time, former FDA Commissioner Jane Henney said the agency "followed to the letter" its normal process for reviewing new drugs.

"We did not let the political climate or political issues around abortion influence what the agency did," Henney said.

Yet the agency issued its first "approvable" letter for Mifeprex in September 1996, weeks before voters reelected President Bill Clinton. Four years later, just in time for another election that could derail the drug's approval, the FDA issued its final decision.

The optics are hard to ignore.

Abortion proponents often point to the lengthy review period as evidence that the FDA did its due diligence. They neglect to mention that the drug sponsor's legal squabbles and struggles to secure a manufacturer extended the timeline, not FDA scrutiny.

After acquiring mifepristone's patent rights from its French manufacturer in 1994, the left-wing Population Council tapped a former business partner, Joseph D. Pike, to lead efforts to bring the drug to the U.S. market. Pike created a complex network of shell companies and began soliciting investors and a manufacturer.

In May 1996, Hungarian drugmaker Gedeon Richter signed on to make the drug. But months later, Pike pleaded guilty to an unrelated misdemeanor forgery charge in North Carolina, alerting the company, the Population Council, and investors to his unsavory past.

By February 1997, the Population Council had filed a lawsuit to oust Pike from the project and Gedeon had terminated its contract.

Lobbyist Kyle Michel lamented the turn of events in a June 1997 memo to Jennifer Klein, First Lady Hillary Clinton's senior domestic policy advisor and a staff member for the president on the Domestic Policy Council.

"The cancellation of the manufacturing contract by Gedeon will cause at least a three to five-year delay in bringing the drug to market, even assuming a new manufacturer is located immediately," Michel wrote, noting that the drugmaker would need FDA approval as well.

He urged Klein to encourage Donald Blinken, then-U.S. ambassador to Hungary and former Secretary of State Antony Blinken's father, to meet with Gedeon's managing director to convince him to reconsider.

"We need the Ambassador to stress to Mr. Bogsch the importance of this product to the current Administration and encourage Gedeon to work with the investor group to work out an interim arrangement whereby the investor group can bring the drug to market on schedule," Michel wrote.

It remains unclear who Michel was lobbying on behalf of, though in his cover letter, he expresses his hope that Gedeon will reverse course and "manufacture the product for us."

He also notes that his letter was a follow-up to a phone call he received from Klein about "the mifepristone matter currently under consideration in [her] office."

This suggests that, contrary to the FDA's claims, White House officials were actively involved in ensuring Mifeprex's approval.

Out of Control

The Population Council eventually secured a Chinese manufacturer for the drug. By April 2006, Mifeprex had been linked to at least six U.S. deaths, including five from septic infections, and public concern was so high that even abortionists who had previously prescribed the pills were rethinking that decision.

"None of these women should be dying; it's shocking," Dr. Peter Bours, an abortion provider in Portland, Oregon, told the New York Times at the time.

The mounting evidence, according to Denver-based Dr. Warren Hern, showed that chemical abortion was riskier than its surgical counterpart. Surgery "should be the procedure of choice," Hern told the outlet.

Dr. Damon Stutes of Reno, Nevada, agreed, noting that he refused to offer chemical abortions as "the complications associated with RU-486 [mifepristone] far exceed the complications of surgical abortion." 

Seeking answers and accountability, members of the House Government Reform Committee held a hearing that May to examine the FDA's decision-making.

Defending the agency's actions, Janet Woodcock, then the director of the FDA Center for Drug Evaluation and Research, testified that Mifeprex's approval followed a review of "three adequate and well-controlled trials" documenting its safety and efficacy.

But Dr. Donna Harrison, director of research for the American Association of Pro-Life OB-GYNs, told Restoration News that the trials did not meet the FDA's typical standards.

"They approved the drug based on a few studies, none of which were blinded, randomized and controlled," said Harrison, who also chairs the Alliance for Hippocratic Medicine, which lost its lawsuit seeking the revocation of mifepristone's FDA approval on a technicality last year.

Harrison noted that the FDA usually requires the submission of two such trials for new drug applications.

A randomized, blinded and controlled trial is one in which participants are randomly assigned to treatment groups—including a baseline control group—without knowing which treatment they're receiving to eradicate any potential bias.

When testing a new drug for which there is no existing treatment, the control group would typically receive a placebo. But in the case of Mifeprex, Harrison said that even today, no such study exists.

"What they have is what's called dose comparator trials where they look at two different doses or different ways of administration," she said. "But they haven't done a placebo control—not that I can find."

(RELATED: Is the Comstock Act the Way to Ban the Abortion Pill?)

'Sloppy' Work

Aside from relying on potentially biased trials, the FDA appears to have eschewed other important standards in approving Mifeprex.

For instance, despite having no clinical data on Mifeprex's effect on minors—data the Population Council initially agreed to provide, per the 1996 approvable letter—the agency approved the drug's use on all age groups.

The FDA also greenlit a new use for misoprostol, the second drug in the chemical abortion regimen, over the manufacturer's objections.

As for the regulation the FDA applied, Subpart H requires that a proposed drug provide "meaningful therapeutic benefit to patients over existing treatments." Yet Harrison said there is no evidence to suggest chemical abortion provides any meaningful benefit over surgical abortion.

"And [the FDA] actually knew that," she added.

An FDA medical officer's 1999 review of U.S. clinical trial data for Mifeprex acknowledges two comparison studies that found chemical abortion was riskier and less effective than surgical abortion.

Specifically, a U.S. study published in 1999 found that drug-induced abortions had a substantially higher failure rate (18.3 percent compared to 4.7 percent), took nearly 10 days longer for the bleeding to stop, were more likely to require unplanned surgical intervention, and caused participants "significantly greater pain, nausea or vomiting" than suction and curettage abortions.

Another study conducted in China, Cuba, and India and published in 1997 yielded similar results.

"Mifeprex has more bleeding, more complications, more retained tissue," Harrison said. "In every place where you compare Mifeprex to surgery, Mifeprex is always worse."

Still, the FDA pushed ahead, even removing some of its own proposed restrictions at the last minute, including an ultrasound requirement.

An ultrasound, Harrison noted, is needed to accurately date a pregnancy and rule out a potentially fatal ectopic pregnancy.

"What they did was a very interesting verbal sleight of hand," she said. "They say a provider must be able to determine the gestational age, but they never said the provider has to determine the gestational age. The sloppiness of the warning allows for women to not get good care."

Conveniently, the two pages of the medical officer's review that might explain the FDA's "sloppiness"—those concerning the agency's deliberative process—are redacted.

FDA Must Act

Even with four years to complete a full and extensive review of Mifeprex, the FDA skirted its own rules to approve the drug for the U.S. market.

Now, a quarter-century later, the complications that made mifepristone risky to begin with have been exacerbated by the agency's hasty removals of the few restrictions that initially governed its use.

Over time, the FDA has expanded Mifeprex's approved use from seven weeks' gestation to up to 10 weeks; lifted previous follow-up requirements; relaxed the qualifications for who could prescribe the drug; nixed reporting requirements for all adverse side effects except death; and stopped requiring patients to see a doctor in-person before taking the pills.

Harrison noted that in making those sweeping changes, the FDA never once made any attempt to ensure the benefits outweighed the risks for women's health.

"That's pretty heinous of the FDA," she said.

Citing FFROA's study, Harrison added that the evidence shows "what women have been told about Mifeprex is just simply not true."

FDA Commissioner Marty Makary has promised, at HHS Secretary Robert F. Kennedy, Jr.'s direction, to review mifepristone's safety and efficacy.

Still, the pills remain widely accessible through unsafe channels. Women across the country can order them online without ever seeing or, in some cases, speaking to a doctor.

Aid Access, for example, claims it will ship the pills to women in every state—even where abortion is banned—upon review of an online form. The organization also offers the pills for the termination of pregnancies up to 14 weeks, even though the medication is only FDA-approved for use up to 10 weeks.

Weldon said the FDA needs to act now to protect women from mifepristone.

"Minimally, I believe those prior restrictions need to be restored, but I would give serious consideration for pulling it from the market as well," he said.

Harrison agreed: "If there is an objective review, then this drug should not be on the market."

(READ MORE Blood on Their Hands: How the Clinton Admin Forced the Abortion Pill on the United States)