FDA Eliminates Key Abortion Pill Restriction

Source: NJ Today.net

The Food and Drug Administration (FDA) did away with an unnecessary rule that required patients to visit hospitals, clinics or doctors’ offices to pick up medication used to terminate early-stage pregnancies.

The World Health Organization reported that over two decades, the health evidence, technologies, and human rights rationale for providing safe, comprehensive abortion care have evolved greatly but despite those advances, an estimated 22 million abortions continue to be performed unsafely each year, resulting in the death of an estimated 47,000 women and disabilities for an additional 5 million women.

The FDA rule change means abortion pills may be prescribed through telehealth consultations with providers and mailed to patients in states where they are permitted by law. Previously, the pills could not be mailed under a regulation that had been temporarily suspended by the FDA.

Mifeprex, also known as mifepristone, when used together with another medicine called misoprostol, is used to end an early pregnancy during the 70 days or less since the first day of the last menstrual period.

Medication abortion is a procedure that uses drugs to end a pregnancy, so it is safer, doesn’t require surgery or anesthesia and can be the most effective treatment during the first trimester. Medication abortion has been used safely in the U.S. for more than 20 years, and millions of people have used it. Unless there’s a rare and serious complication that’s not treated, there’s no risk to your future pregnancies or to your overall health.

The FDA announced its permanent repeal of the in-person dispensing requirement for mifepristone, one of a set of unnecessary restrictions known as the Risk Evaluation and Mitigation Strategy (REMS), which had mandated that patients obtain the medication in person at a doctor’s office, hospital, or health center instead of from a pharmacy or by mail, which is allowed for most other equally safe medications.

Calling the news “a victory for public health and health equity,” Planned Parenthood Federation of America CEO Alexis McGill Johnson said, “Let’s be clear: The FDA followed the science in arriving at this decision. There is overwhelming evidence that medication abortion can be safely and effectively provided through telehealth.”

“We’ve seen very clearly in the past two years that the logistical hurdle of unnecessary travel to health centers during a dangerous pandemic only creates more barriers to care, especially for people of color and people with low incomes,” Johnson added. “Abortion is time-sensitive, essential health care, and this decision will remove a sometimes insurmountable barrier for patients seeking an abortion.”

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