FDA Used Incomplete Data To Justify Deregulation of Chemical Abortion Pills, Studies Show

Agency relies on data submitted by drug’s distributors

Patrick Hauf • December 23, 2021 12:00 pm

The Food and Drug Administration relied on incomplete data to reach its determination that it is safe to deregulate chemical abortion pills, according to medical studies.

FDA officials brushed aside concerns that women who obtain chemical abortion pills without an in-person doctor visit might put their health at risk. The agency did so by pointing to its Adverse Event Reporting System, which catalogues deaths and other side effects from abortion drugs like mifepristone. That government database, however, fails to encompass the actual number of serious medical incidents—the FDA does not require emergency rooms to report adverse effects from the drug. Medical studies show that thousands of women annually end up in emergency rooms after taking mifepristone. None of their cases are guaranteed to show up in government data.

The reporting system relies on data submitted by the makers of chemical abortion pills, who in turn gather data from doctors who prescribe the drugs. And a new study published this week shows the FDA reports a fraction of the data it is required to collect. Three board-certified OB-GYNs found that adverse effects reported by Planned Parenthood did not show up in the FDA database. In 2009 and 2010, for example, Planned Parenthood reported 1,530 adverse events in women who received mifepristone. The doctors found the FDA database for that time period only showed 664 complications.

Experts say the result makes chemical abortion pills seem far safer than they actually are. Dr. James Studnicki, a former medical school professor at Johns Hopkins University and the University of North Carolina, said the real number of adverse effects dwarfs the FDA’s estimate. But he says the agency shows no sign it cares whether its data are accurate.

“If you don’t want to find something, then don’t look for it and pretend you’re looking,” Studnicki told the Washington Free Beacon.

Efforts to deregulate chemical abortion pills gained traction this year as states across the country passed the most abortion restrictions in a single year since the monumental Roe v. Wade decision. Over 70 Democrats cosponsored legislation in August that called for widespread access to chemical abortion pills. Plan C, a website that details how to purchase black-market chemical abortion pills online, said it had a significant increase in traffic in Texas after the state enacted its six-week abortion ban.

Mifepristone is sold under the brand name Mifeprex by Danco Laboratories. Until 2016, the FDA required Danco to report all adverse events, including ongoing pregnancies and hemorrhages, to the database. That year, the FDA changed the requirement to exclude deaths.

An FDA spokeswoman told the Free Beacon that the agency “does not comment on specific studies” but “continues to closely monitor the postmarketing safety data on mifepristone.” Neither Planned Parenthood nor Danco responded to a request for comment.

Advocates of mifepristone deregulation cite studies that show rates of adverse events at well below one percent, but these studies also rely on data from the drug’s distributors. A 2015 study in California conducted by prominent pro-abortion researchers found that when emergency room visits are tallied, the adverse event rate for chemical abortion pills is 5.2 percent.

Danco took millions of dollars from liberal foundations run by Warren Buffett, George Soros, and David Packard before mifepristone gained FDA approval in 2000.

Studnicki says the abortion lobby has leveraged its ties to the Democratic Party to elide the dangers of chemical abortion pills.

“Between politics and controlling the science, they’ve been able to provide this distorted view of reality,” he tells the Free Beacon. “And the FDA is complicit in this.”