Watchdog Calls on FDA to Seize Website Domains Promoting Dangerous and Unproven “Abortion Reversal” Medication
FOR IMMEDIATE RELEASE: May 20, 2020
Contact: Michael Clauw, email@example.com, 202.780.5750
WASHINGTON, D.C. – Today, Campaign for Accountability (CfA), a nonprofit watchdog group focused on public accountability, submitted a letter to the United States Food and Drug Administration (FDA) requesting that the agency seize the websites of any entity improperly marketing an unapproved procedure known as ‘Abortion Pill Reversal.’ The unsound therapy involves administering high doses of progesterone to those who have taken mifepristone, the first of two drugs used for a medical abortion, while simultaneously discouraging consumption of the second drug, misoprostol. Neither the use of mifepristone without misoprostol, nor this use of progesterone, is approved by the FDA and has led to serious health consequences. CfA has identified three anti-choice groups: Abortion Pill Rescue, American Pregnancy Association, and Obria Medical Clinics among those currently marketing these treatments on their websites.
CfA Counsel Alice Huling said, “Ideologically driven zealots are promoting misuse of a federally regulated drug despite indications that such use can result in dangerous health outcomes. The FDA must put an end to the promotion and use of this unsound treatment.”
The FDA has the authority to seize websites or issue warning letters to those selling or promoting drugs in violation of the Federal Food, Drug and Cosmetic Act (FD&C Act). The FDA regularly takes action against those who mislead the public about the safety of drugs.
Dr. George Delgado first proposed the administration of large doses of progesterone in 2012 as a way to “reverse” a medication abortion after a patient has taken mifepristone. Mifepristone causes the pregnancy to detach from the uterine lining, and Dr. Delgado’s unproven hypothesis is that administering large doses of progesterone can counteract its effects.
In 2019, researchers at the University of California, Davis conducted a limited trial of Dr. Delgado’s abortion reversal method, but were forced to halt their study after three of twelve women enrolled were hospitalized for severe vaginal bleeding. Two previous case studies conducted by Dr. Delgado have been shown to be deeply flawed.
Abortion Pill Rescue is operated by Heartbeat International, an organization that recently joined over 50 other anti-choice groups in signing on to letter asking the FDA to seize the websites of providers offering medication abortion for home use. Medication abortion was first approved by the FDA in 2000. When taken as prescribed, it has an efficacy rate over 96%. Further, it is widely considered safe for at home use. The anti-choice groups’ request is particularly reckless during the current pandemic, when safe and effective at-home treatments are favored over those that require risking disease spread by leaving home.
Obria Medical Clinics’ track record of providing incomplete and inaccurate advice surrounding pregnancy and abortion goes far beyond its website content. Obria operates a network of ideology-driven crisis pregnancy centers across the country, often disguised as genuine family planning clinics to trick patients into thinking they are receiving unbiased medical information. CfA has filed numerous actions and complaints alleging Obria has failed to follow the dictates of Title X in spending the $1.7 million federal grant money it received in 2019.
Ms. Huling continued, “It’s bad enough for anyone to promote an unproven medical procedure in violation of the FD&C Act, but it’s outrageous when a group getting taxpayer support, like Obria, does it. Absent FDA action, women have no way of knowing that abortion reversal isn’t real or safe. The FDA should immediately shut down any website promoting this unproven, dangerous procedure.”
Campaign for Accountability is a nonpartisan, nonprofit watchdog organization that uses research, litigation, and aggressive communications to expose misconduct and malfeasance in public life and hold those who act at the expense of the public good accountable for their actions.