Wednesday, October 24, 2018

FDA Investigation Targets Website That Mails Abortion Pills to Women in the U.S.

Gizmodo (Oct. 22, 2018): FDA Investigation Targets Website That Mails Abortion Pills to Women in the U.S., by Melanie Ehrenkranz:

Aid Access, a website established by Women on Web founder Rebecca Gomperts, is the target of a new Food and Drug Administration investigation, as reported by The Daily Beast.

Aid Access requires women to fill out a consultation form online stating that they are no more than nine weeks pregnant. For women who pass the online screening process–they must say they are less than ten weeks pregnant, and live within one hour of a hospital – Gomperts, a doctor, fills the prescriptions herself and sends them to a pharmacy in India. The group has already mailed medication abortion to about 600 women.

The FDA investigation, the agency says, was triggered by the website's sale of mifepristone. 

“Mifepristone, including Mifeprex, for termination of pregnancy is not legally available over the Internet,” the FDA said in a statement to Gizmodo. “The agency takes the allegations related to the sale of mifepristone in the U.S. through online distribution channels very seriously and is evaluating the allegations to assess potential violations of U.S. law.”

The FDA says that only approved health care providers can prescribe and offer mifepristone, and that the pill can only be dispensed in certain health care settings including “clinics, medical offices and hospitals, by or under the supervision of a certified prescriber.”

Gomperts told The Atlantic that Aid Access is legal because the FDA allows the importation of medicine for personal use. Mifeprex, the brand name for mifepristone, has been FDA-approved since 2000. The FDA, however, subjects mifepristone to a strict distribution protocol, which prevents it from being sold online or in retail pharmacies.

Numerous medical groups, including the American College of Obstetricians and Gynecologists, have challenged the FDA protocol, saying it is outdated and inconsistent with the requirements for other drugs with even greater risks.

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