FDA approves new abortion drug label, making it easier for women seeking procedure

FDA approves new abortion drug label, making it easier for women seeking procedure

By Kwame Opam on March 30, 2016

In a major victory for reproductive rights advocates, the FDA has just approved new labeling requirements for mifepristone, the most widely used abortion drug in the country. The decision will make it easier for millions of women seeking a medication abortion to get one, and undercuts legislation supported by anti-abortion lawmakers across the country.


The new requirements do three things: reduce the dosage needed to terminate a pregnancy from 600mg to 200mg; reduce the number of times the patient needs to visit their doctor from three times to twice; and widens the window to take the drug from 49 to 70 days after the patient’s last period. The changes actually line up with how doctors have been prescribing the drug for years. According to The New York Times, doctors say that the original requirements, based on clinical evidence gathered in the mid-1990s, are outdated. For instance, the lower dosage comes with a decreased risk for side effects. Because of this, physicians would prescribe the drug using a regimen unlike what the label suggested; and the FDA just upheld the practice.

The original requirements have been used by legislators in states like Ohio and North Dakota to restrict access to the drug. After the FDA approved mifepristone in 2000, some states passed laws that require doctors to be physically present when the drug is administered; often making for costly trips to doctors’ offices for women living in rural areas. Texas even passed a law that requires four visits, putting an insurmountable barrier between many women and the care they need.

These laws are designed in the name of public health and safety, but fly in the face of scientific evidence. The FDA reported in 2011 that, of the 1.52 million who’d taken mifepristone since it was approved, only 612 suffered serious complications.


Today’s decision effectively undermines those laws. Planned Parenthood hailed the move. “Since Planned Parenthood’s medical standards are constantly-evolving with the latest clinical research findings, we have actually had the protocols approved today in place at Planned Parenthood for some time,” said Planned Parenthood chief medical officer Raegan McDonald-Mosley. “But given the restrictions on medication abortion enacted at the state level in recent years, updating the label to reflect best medical practice represents a significant step forward for science, for women, and for health care providers who want to give our patients the highest quality care.”

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