FDA Eases Requirements on Abortion Pill Label. Will It Help Sway Anti-Abortion States? | Pharma Industry Regulation | Scoop.it

The Food and Drug Administration stepped into the politics of abortion on Wednesday, relaxing the requirements for taking a medication that induces abortion, a move that is expected to expand access to the procedure.

The move was a victory for abortion rights advocates who had been fighting laws in states like Texas, North Dakota and Ohio that required providers to follow the requirements on the original F.D.A. labels for the drug when conducting abortions by medication. Many doctors say the original labels, based on clinical evidence from the 1990s, were outdated and that the state laws went against accepted medical practice and made it harder for women to get abortions.

The changes announced on Wednesday reduce the number of trips women have to make to a doctor from three to two in most states, and also increase the number of days that she has to be able to use medication to induce abortion from 49 to 70 days after the beginning of her last menstrual period, experts said. The new label also reduces the dosage of the drug, called mifepristone, from 600 milligrams to 200. Most medical societies had said the previous dosage was too high, and abortion rights advocates said it increased the cost and the side effects of the procedure.

In most states, doctors had been following the medically-accepted regimen, despite the fact that the label advised otherwise. That is fairly common in medical practice and is known as off-label use.

“This is a huge step in increasing access to medication abortion and it comports with the scientific evidence,” said Elizabeth Nash, a senior state issues associate at the Guttmacher Institute, which tracks women’s reproductive health issues. She said that medication abortions accounted for about a quarter of all abortions in 2011, the last year measured by the institute.

The American Congress of Obstetricians and Gynecologists said in a statement that it was “pleased that the updated FDA-approved regimen for mifepristone reflects the current available scientific evidence and best practices.”

The group added that “medication abortion has been subject to legislative attacks in various states across the country, including mandated regimens that do not reflect the current scientific evidence. We hope that these states take the FDA label into account.”