European Doctor Who Prescribes Abortion Pills To U.S. Women Online Sues FDA

Sep 9, 2019
Originally published on September 9, 2019 4:03 pm

Updated at 5 p.m. ET

A European doctor who prescribes abortion pills to American women over the Internet is suing the Food and Drug Administration in an effort to continue providing the medications to patients in the United States.

The lawsuit being filed Monday in federal court in Idaho names several federal officials, including U.S. Health and Human Services Secretary Alex Azar.

In the lawsuit, Dr. Rebecca Gomperts says she believes federal officials have seized between three and 10 doses of abortion drugs she has prescribed through her organization, Aid Access, since March. It also says Gomperts believes the government has blocked Aid Access from receiving payments from some patients.

Gomperts' attorney, Richard Hearn, said the goal of the lawsuit is to force the FDA to stop those actions and to prevent Gomperts or her patients from being prosecuted under federal law.

Hearn argues that for many women who live long distances from the nearest clinic, abortion pills ordered online are the only practical way to exercise their legal right to an abortion.

"Some women in the United States can exercise that right just by going down the street if those women happen to live in New York or San Francisco or other major metropolitan areas on either one of the coasts," Hearn said in an interview with NPR. "But women in Idaho and other rural states, especially conservative states ... cannot exercise that right."

A handful of states have only one clinic that provides abortions, forcing patients to drive hundreds of miles to obtain one. Under the Trump administration, organizations that provide or refer patients for abortions face new restrictions on how they can obtain funding to provide other kinds of reproductive health care, which could push some providers to stop offering the procedure. And many states are attempting to restrict the procedure in state law or by imposing heavy regulations on clinics.

Since March 2018, the lawsuit says, 37,000 women from all 50 states in the U.S. have contacted Aid Access. Gomperts, who divides her time between Austria and the Netherlands, prescribed the medication to more than 7,000 U.S. patients seeking to end first-trimester pregnancies during that time, according to the lawsuit.

The drugs, mifepristone and misoprostol, are both approved by the FDA to induce abortion under a doctor's direction. The World Health Organization recommends a protocol that involves taking the two drugs in tandem. Mifepristone is especially heavily regulated in the U.S. and cannot be obtained at a commercial pharmacy, making it difficult for many women to obtain it.

Gomperts uses telemedicine to consult with patients online, writes a prescription and provides instructions on how to request the medication from an exporter in India, Hearn said. The pills are then shipped to patients' homes.

In March, the FDA issued a warning letter accusing Aid Access of violating federal law by misbranding and facilitating the improper distribution of the drugs. The letter said that the "sale of misbranded and unapproved new drugs poses an inherent risk to consumers who purchase those products." The agency ordered Aid Access to stop distributing the medications in the United States or face repercussions, including the seizure of the drugs, without notice.

Gomperts stopped prescribing the medications to U.S. patients for about two months, from roughly mid-March to mid-May, before resuming, according to her attorney.

"The FDA is a huge institution. It's very powerful, and it's a form of intimidation that is quite severe," Gomperts said in an interview with NPR. "I would say a form of bullying. And so I think it's very important to stand up against it."

Gomperts said she charges the equivalent of about $90 for patients in the United States, which covers the consultation, prescription and medication. She said patients who cannot afford that amount are asked to pay what they can.

Hearn said Gomperts has heard from women who say they've been contacted by federal officials and apparently had medications seized.

"A couple have gotten letters, one has gotten visited, and those pills were not delivered. And we have tracking information," Hearn said. "The real fear about seizing medicines is not the loss of the medicine, but it's prosecution of the woman in the United States ... either by the state or the federal government, for ordering the pills."

Hearn points to a separate federal indictment earlier this year, which accused a New York woman, Ursula Wing, of illegally importing and distributing abortion drugs. If convicted, the lawsuit says, Wing could face several years of prison time, federal fines or both.

FDA officials declined to comment on the pending litigation or any potential or pending regulatory actions against Gomperts and Aid Access. Asked if patients who purchase abortion pills could be prosecuted, officials said in a statement emailed to NPR that it is usually illegal to import drugs for personal use but that the FDA "generally does not take enforcement action against individuals" who do so.

The statement added, "FDA remains very concerned about the sale of unapproved mifepristone for medical termination of early pregnancy on the Internet or via other channels for illegal importation, because this bypasses important safeguards designed to protect women's health."

Gomperts said she believes patients can safely self-induce what is essentially an early miscarriage, provided they have proper information and support.

"What I think is very important is to really understand that women have been dealing with miscarriages forever," Gomperts said. "And a medical abortion, abortion with pills, is very similar."

Abigail Aiken, a public affairs professor at the University of Texas, Austin, has been studying Aid Access and its patients. In a recent study published in the journal BMJ, Aiken examines some of the reasons women seek abortion drugs online, including increased restrictions on the procedure in many states.

"There is certainly interest, and it appears to be becoming more intense," Aiken said in an interview with NPR.

Aiken said some patients also prefer to take pills privately, at home, rather than going to a clinic. Others face obstacles such as ultrasound requirements, long waiting periods and cost, she said.

"There are some folks who would like to get to an abortion clinic, but they're not able to," Aiken said. "And this is especially pronounced in states that have restrictive abortion policies."

Copyright 2019 NPR. To see more, visit https://www.npr.org.