Dozens of pro-life and family organizations wrote to the Food and Drug Administration (FDA) Monday, urging seizure of the website domains for two organizations accused of flouting federal law overseeing chemical abortion drugs.
"We are writing to urge you to seize the website domains for AidAccess, Rablon, and any other entities illegally prescribing and/or selling mifepristone in the United States, and to further investigate their practices …" the groups state in a letter. “We urge FDA to protect women from the distributers of abortion-inducing drugs who place lives at risk by circumventing your agency’s regulatory safeguards.”
More than 50 groups signed the letter to the FDA concerning AidAccess.org and Rablon, both of which were sent warning letters by the federal agency in March 2019.
“It has been over a year since FDA sent warning letters to AidAccess and Rablon stating that the websites are in violation of U.S. law,” the letter states. “Yet, these websites remain active and continue to dispense abortion-inducing drugs, including mifepristone, through internet prescriptions or orders that are purportedly filled by pharmacies in India, and then shipped to customers in the United States.”
“Their actions brazenly flout FDA-required protections for women using abortion-inducing drugs,” the pro-life groups say.
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Citing the March 8, 2019, warning letters, the groups said the FDA had stated that AidAccess “cause[s] the introduction into interstate commerce of misbranded and unapproved new drugs,” and Rablon “introduces into interstate commerce misbranded and unapproved new drugs,” both in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).”
“The letters warn that “[f]ailure to correct these violations may result in FDA regulatory action, including seizure or injunction, without further notice,” they add.
Abortion proponents have been pushing for relaxation of the Risk Evaluation and Mitigation Strategy (REMS) classification for chemical abortion drugs with the current coronavirus as justification. They use the purported rationale that pregnant women need easier access to the drugs in the face of some U.S. states banning elective procedures, abortion among them, to preserve personal protective equipment (PPE) during the virus outbreak.
The pro-life groups note in the letter how Mifeprex, or its generic alternative, used in combination with misoprostol, is the only FDA-approved regimen for chemical abortion, also known as medical or drug-induced abortion.
“Mifeprex is subject to a Risk Evaluation and Mitigation Strategy (REMS), which, as stated in the warning letters, “is intended to mitigate the risk of serious complications associated with Mifeprex,” the pro-life groups state. “Further, “[c]onsistent with the REMS, Mifeprex is not sold through retail pharmacies or over the internet.”
They continue, pointing out that the Mifeprex REMS mandates the abortion drug be dispensed at a healthcare facility, “by or under the supervision of a certified prescriber,” and with the patient signing an agreement form.
They contend that the requirements also protect pregnant women and their unborn children from predators who would trick or otherwise coerce the women into taking Mifeprex.
“Tragically, internet access to abortion-inducing drugs has enabled these crimes,” they state. “However, AidAccess3 and websites within Rablon’s network continue to flagrantly subvert the REMS by marketing mifepristone to U.S. customers.”
Dr. Rebecca Gomperts, founder of Aid Access, had said previously said she wouldn't be "deterred" by the FDA, Fox News reports.
"When U.S. women seeking to terminate their pregnancies prior to nine weeks consult me, I will not turn them away,” said. “I will continue to protect the human and constitutional right of my patients to access safe abortion services."
Gomperts also claimed the FDA was violating the constitutional rights of women, saying, "The FDA is violating the rights of all U.S. women seeking safe abortion by preventing them from accessing necessary medications."
Gomperts sued the FDA last year to continue offering chemical abortion pills via the internet.
In its motion to dismiss the lawsuit, the FDA explained how the abortion drugs provided by Gomperts did not meet FDA standards:
The mifepristone that Dr. Gomperts prescribes is neither FDA-approved Mifeprex nor the FDA-approved generic version. …Nor is it dispensed in a clinic, medical office, or hospital, as FDA-approved Mifeprex must be. Instead, the unapproved product is exported from India by N N Agencies and shipped to patients (Gomperts v. Azar, No. 1:19-cv-00345-DCN (Dist. of Idaho)).
The effort urging the FDA to take action against the two entities providing abortion drugs over the internet in violation of federal law is being led by Susan B. Anthony List and its associated Life Issues Institute. Heartbeat International is a signatory of the letter.
The letters signers are:
Marjorie Dannenfelser President Susan B. Anthony List; Donna J. Harrison, MD Executive Director American Association of Pro-Life Obstetricians and Gynecologists; Kristan Hawkins President Students for Life of America & Students for Life Action; Catherine Glenn Foster President & CEO Americans United for Life; Jeanne Mancini President March for Life; Jor-El Godsey President Heartbeat International; Lila Rose President and Founder Live Action; Russell Moore President Southern Baptist Ethics & Religious Liberty Commission; Penny Young Nance CEO and President Concerned Women for America LAC; Dorinda C. Bordlee Chief Counsel Bioethics Defense Fund; Carol Tobias President National Right to Life; Ellen Gianoli, BSN, MA, RN President National Association of Catholic Nurses, U.S.A.; Jeffrey Barrows, DO, MA Senior VP, Bioethics and Public Policy Christian Medical & Dental Associations; Michelle Cretella Executive Director American College of Pediatricians; Kris Held, MD President Association of American Physicians and Surgeons; Bradley Mattes President Life Issues Institute; Fr. Frank Pavone National Director Priests for Life; Tom Brejcha President and Chief Counsel Thomas More Society; Eunie Smith President Eagle Forum; Roland C. Warren President & CEO Care Net; Thomas A. Glessner President National Institute of of Family & Life Advocates (NIFLA); Brian Fisher President Human Coalition; Greg Schleppenbach Associate Director USCCB Secretariat of Pro-Life Activities; Tami Fitzgerald Executive Director NC Values Coalition; Jessica Anderson Executive Director Heritage Action; Michael Gonidakis President Ohio Right to Life; Jordan Sekulow Executive Director American Center for Law & Justice; Cheryl Sullenger Senior Vice President Operation Rescue; Travis S. Weber Vice President for Policy and Government Affairs Family Research Council; Allan Parker President The Justice Foundation; Autumn Leva Vice President, Strategy Family Policy Alliance; Bev Cielnicky President Crusade for Life; Judie Brown President American Life League; Lauren Muzyka Executive Director Sidewalk Advocates for Life; Jim Sedlak Founder STOPP International; Eric J. Scheidler Executive Director Pro-Life Action League; Esther Ripplinger Executive Director Human Life of Washington, Peggy Nienaber Vice President Faith & Liberty, Cynthia Collins Global Advisor Operation Outcry, Joe Langfield Executive Director Human Life Alliance, Lois Anderson Executive Director Oregon Right to Life; Samuel H. Lee Director Campaign Life Missouri; Marc Tuttle President Right to Life of Indianapolis; Bethany Bomberger Executive Director The Radiance Foundation; John Helmberger Chief Executive Officer Minnesota Family Council; Connie Eller Founder Missouri Blacks for Life; Julaine K. Appling President Wisconsin Family Action; David Fowler, Esq. President The Family Action Council of Tennessee, Inc.; Steven Ertelt Editor LifeNews.com; Kelsey Hazzard President Secular Pro-Life; Mark Harrington President Created Equal; Christopher Bell President Good Counsel, Homes for Mothers and Babies; Eva Andrade President Hawaii Family Forum; Cathie Humbarger Executive Director Right to Life of Northeast Indiana; Alexandra Snyder, Esq Executive Director Life Legal Defense Foundation; Bryan Kemper President Stand True Youth Pro-life Outreach
Editor's note: Heartbeat Intentional manages the Abortion Pill Rescue Network and Pregnancy Help News.
