Thursday, March 31, 2016

FDA Changes Guidelines on Medication Abortion

New York Times (March 31, 2016): New FDA Guidelines Ease Access on Abortion Pill, by Sabrina Tavernise:

The Food and Drug Administration has updated its guidelines on mifepristone, the drug that is used for medication abortions.   The change brings the guidelines in line with the  current standard medical protocol.  The new guidelines reduces the dosage to 200 milligrams from 600 milligrams, decreases the number of visits a woman must make to a doctor to two from three, and extends the period when she can take the pill to 10 weeks from seven weeks.

Although drugs are commonly used off-label, many states have passed laws that require that medication abortion drugs only be used in accordance with FDA guidelines even though the old guidelines were based on clinical evidence from the 1990s.  As a result, the laws required doctors to prescribe higher dosages, required women to make more visits to their doctor and limited the availability of the drug to earlier stages of pregnancy.

The change in the guidelines should allow doctors to prescribe mifepristone consistently with medical best practices in states that require that the FDA guidelines be followed.  However, many states have independently codified elements of the old protocol, such as the number of doctors' visits required.  It is unclear whether the change in the FDA guidelines will trigger reform efforts in those states.

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