Drugs

Doctor Sues FDA Over Internet Abortion Drugs

A Dutch physician has sued FDA in Idaho federal court after the agency seized several international packages containing abortion drugs that were addressed to women who were prescribed them. The physician, Rebecca Gomperts, is located in Amsterdam, and she uses a Web site called Aid Access to prescribe and complete related transactions. The lawsuit also alleges that FDA and the government have blocked payment transactions from U.S. customers.

“For many women seeking to terminate their unwanted pregnancies ... their only practical option is found on the Internet,” the lawsuit says. The agency is “actively using the power of the government to deny ... patients their constitutionally protected right to terminate” their pregnancies, it contends.

According to the lawsuit, Gomperts has prescribed abortion pills to more than 7,000 American women. The drugs prescribed, mifepristone and misoprostol, are approved by FDA, and the versions prescribed by Aid Access are reportedly sourced and shipped from China.

In March, FDA sent a Warning Letter that cited Gomperts’ Web site for facilitating the “sale to U.S. consumers of unapproved mifepristone in a regimen with unapproved misoprostol labeled for the termination of pregnancy.” It charged that the Web site marketed a combination pack that includes both mifepristone and misoprostol tablets that is labeled as a “Combipack of Mifepristone Tablets IP & Misoprostol Tablets IP.”

The letter said that the substitution of unapproved drugs for FDA-approved prescription drugs poses significant health risks to U.S. consumers. “For example, in this case, use of the unapproved drug would not be subject to the same protections as use of the FDA approved product,” it said. The U.S. approved product, Mifeprex, is only available in the U.S. through a Risk Evaluation and Mitigation Strategy (REMS) program.

The letter further said: “The REMS program is intended to mitigate the risk of serious complications associated with Mifeprex by: requiring healthcare providers who prescribe Mifeprex to be certified in the Mifeprex REMS program; ensuring that Mifeprex is only dispensed in certain healthcare settings by or under the supervision of a certified prescriber; and informing patients about the risk of serious complications associated with Mifeprex. Consistent with the REMS, Mifeprex is not sold through retail pharmacies or over the internet.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome