FOIAengine: Advocates on Both Sides Push FDA for Data as a Senate Investigation Begins
Even before Sen. Josh Hawley (R-Mo.) walked into a March 11 news conference to kick off an effort to ban the abortion drug mifepristone as unsafe – and days before he opened an investigation into its manufacturers – signals were pointing to a new phase in America’s abortion debate.
In a post-Dobbs world, pressure is mounting on the Food and Drug Administration to reconsider how abortion medications are approved, distributed, and monitored.
As Hawley strode to the podium, a large sign on an easel to his left declared: “Abortion Drugs Hurt Women.” Hawley, who had just introduced legislation to ban the drug, singled out one of its manufacturers, Danco Laboratories. He claimed that 11 percent of the millions of women who take mifepristone have suffered a “serious adverse health event” such as sepsis or hemorrhaging – 22 times higher than what the company reports on its label.
But Hawley also acknowledged the political reality: the chances of sweeping action by a closely divided Congress are uncertain at best.
Increasingly, the fight is not over whether abortion is legal, but over how it is administered – and who controls the systems that make it possible.
That helps explain why attention is shifting elsewhere. Even as lawmakers stake out positions, a quieter but consequential effort is underway – one that focuses not on votes, but on documents and records.
The next phase of America’s abortion debate may not play out in courtrooms or state legislatures – but, instead, in the inboxes of federal regulators. A growing number of Freedom of Information Act requests targeting abortion-inducing drugs suggests that the fight is moving toward the FDA and the internal decision-making behind widely used medications like mifepristone.
At risk are the lucrative, and secretive, franchises managed by the drugs’ two major U.S. distributors, Danco Laboratories and GenBioPro. Both companies are privately held, have only one product, and don’t release information about their revenue or operations. Neither company replied to our questions about whether they would comply with Hawley’s extensive investigative requests for documents. Hawley gave the companies an April 24 deadline.
We last wrote about mifepristone almost three years ago, when Biden-era regulators were in charge. (See “FOIA Requests Presaged the Post-Roe Fight Over Abortion Rights.”) But after Hawley’s flurry of activity last month targeting the abortion drug makers – seeking to roll back or end altogether the FDA’s approval of drugs used to end pregnancies – we turned to PoliScio Analytics’ competitive-intelligence database FOIAengine, which tracks FOIA requests in as close to real-time as their availability allows, to see whether abortion opponents might be turning their fire on the FDA.
FOIA requests to the federal government can be an important early warning of bad publicity, litigation to come, or uncertainties to be hedged and gamed out. In this case, we found a surge of recent requests aimed at how abortion medications are approved, distributed, and monitored – often focusing on internal FDA communications, safety data, and the expansion of mail-order access.
The requests are from advocacy groups across the political spectrum – each seeking records that could shape the next round of litigation, legislation, or public debate.
Two of the most recent requests on file came from Kathryn Huth, a paralegal at Judicial Watch, the conservative legal advocacy group.
Judicial Watch is by far the most aggressive FOIA litigant in federal court. When our Law Street colleague David Nayer ran the totals last July, he reported that the group had filed 410 FOIA lawsuits over the past decade – more than twice that of the runner-up, American Oversight.
On February 25, Huth submitted requests that sought, among other things, “all communications sent to, received by, or copied to the Commissioner of Food and Drugs, or to the Commissioner s immediate office, that concern, refer to, or discuss mifepristone, RU-486, or any generic or branded form of mifepristone approved, regulated, or reviewed by the Food and Drug Administration,” as well as any documents related to any meeting with the Commissioner of Food Drugs “regarding Checkmate Government Relations where mifepristone, RU-486, or any generic or branded form of mifepristone approved, regulated, or reviewed by the Food and Drug Administration was discussed.” (Mifepristone was originally developed under the name RU-486.)
According to OpenSecrets.org, Checkmate Government Relations (“…we make sure our clients win”) reported more than $22 million in lobbying fees last year from 86 clients in a diverse array of businesses, including gun makers, tobacco and vaping companies, pharma giants, and gambling operators. The lobbying disclosures showed no indication that Checkmate represents the manufacturers of mifepristone. Checkmate didn’t respond to our request for comment.
A month before the Judicial Watch request, Liz McCaman Taylor, senior counsel at the Center for Reproductive Rights, asked the FDA to produce communications between the agency and the American Association of Pro-Life Obstetricians and Gynecologists, a physicians’ group that has been active in litigation and regulatory challenges involving mifepristone.
“Releasing this information,” Taylor said in her January 28 request, “is vital to public
interest and understanding of potential political interference at FDA regarding mifepristone. Any potential reduction in mifepristone access will harm the millions of people who rely on the drug for essential health care, as mifepristone has been declared safe and effective for abortion by FDA for 25 years, with more than 7.5 million women in the United States having used mifepristone safely.”
The prior November, months before Taylor’s request, the pro-life physician’s association had requested “PDFs of all Adverse Event Reports for Deaths reported related to mifepristone.”
The filings reflect the broadening shift in the abortion debate following the Supreme Court’s 2022 decision overturning Roe v. Wade. With access to clinic-based procedures increasingly restricted in some states, medication abortion – typically involving mifepristone followed by misoprostol – has become a central focus for both supporters and opponents of abortion rights. Medication abortion has accounted for a growing share of abortions in the United States in recent years, according to published research and regulatory data.
That shift has, in turn, redirected attention toward the FDA, which approved mifepristone in 2000 and regulates it under a Risk Evaluation and Mitigation Strategy, or REMS, program. Under that framework, the agency sets conditions for prescribing, dispensing, and monitoring certain medications. Changes to those rules – particularly those allowing telehealth prescribing and dispensing by mail – have become a focal point for both litigation and FOIA scrutiny.
Cases in Louisiana, Missouri, and elsewhere seek to force the FDA to tighten restrictions or revisit earlier regulatory decisions, including those allowing mail distribution. In Georgia, a criminal case involving abortion medication obtained online highlighted the legal uncertainties surrounding medication-based abortions in the post-Dobbs landscape.
Another legal dispute involves the Comstock Act, a 19th-century federal law that restricts mailing items used for abortion. The question is whether that statute can be applied to block shipment of abortion drugs across state lines – and issue that has taken on renewed importance as policymakers and litigants test whether a law written for a different era can govern modern pharmaceutical distribution.
The FDA’s handling of the newest entrant into the market has also drawn attention from advocacy groups on both sides of the issue. On December 18, Skye Perryman of Democracy Forward, a legal advocacy group aligned with Democratic policy priorities, sought records related to potential political interference in agency decisions affecting abortion medications. Two weeks earlier, Abigail Forman of Liberty Counsel Action, a group dedicated “to expos[ing] the truth about the abortion pill,” requested documents aimed at scrutinizing the FDA’s approval and oversight of those same drugs.
Both requesters sought information related to the FDA’s recent approval of a third mifepristone manufacturer, Evita Solutions.
Taken together, these and many other recent FOIA requests show how, in the emerging battle over abortion drugs, the same set of FDA records is being pursued by opposing sides – less to establish a shared set of facts than to support fundamentally different legal and political arguments.
The trend fits a familiar model. Requests for internal documents often precede major developments, whether in the form of litigation, regulatory action, or investigative reporting. They offer a glimpse of where attention is building – and where pressure may soon follow.
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John A. Jenkins, co-creator of FOIAengine, is a Washington journalist and publisher whose work has appeared in The New York Times Magazine, GQ, and elsewhere. He is a four-time recipient of the American Bar Association’s Gavel Award Certificate of Merit for his legal reporting and analysis. His most recent book is The Partisan: The Life of William Rehnquist. His next book, Summer of ’71: Five Months That Changed America, about the fateful year before Watergate, will be out in June. Click here to watch the official book trailer. Jenkins founded Law Street Media in 2013. Prior to that, he was President of CQ Press, the textbook and reference publishing enterprise of Congressional Quarterly. FOIAengine is a product of PoliScio Analytics (PoliScio.com), a new venture specializing in U.S. political and governmental research, co-founded by Jenkins and Washington lawyer Randy Miller. Learn more about FOIAengine here. To review FOIA requests mentioned in this article, subscribe to FOIAengine.
Write to John A. Jenkins at JAJ@PoliScio.com.
