The Food and Drug Administration has relaxed label requirements for taking the abortion-inducing mediation Mifeprex (mifepristone), a move that may make it easier to prescribe the drug in states that have laws regulating its usage.
The requirements expand on-label usage to 70 days after the patient's last menstrual period. Previously, the label recommended the drug be used within 49 days of the last period.
It also reduces the number of doctor visits for the procedure from three to two.
The political ramifications of this move are fairly straightforward. Several states, including Ohio and Texas, have drafted laws requiring providers to follow the FDA's on-label requirements when prescribing mifepristone, also known as RU-486. Those actions make it more difficult to prescribe the drug in the affected states because its typical medical use is now off-label.
That off-label usage is similar to today's FDA announcement, based on medical experience gained since the drug first was approved in 2000 in the U.S. Thus, the move puts the label in line with drug usage, potentially making it easier to prescribe mifepristone in some states that had drawn up laws based around label requirements.
In a statement, the American Congress of Obstetricians and Gynecologists (ACOG) indicated its support for the FDA's move. "ACOG is pleased that the updated FDA-approved regimen for mifepristone reflects the current available scientific evidence and best practices, and includes many of the recommendations that ACOG had presented to the agency," the physician group said.
The FDA also reduced the dosage for the drug from 600 milligrams to 200 milligrams -- again in line with typical off-label practices. That could reduce the cost and potential side effects of the drug.