FDA relaxes mifepristone protocol | Arkansas Blog

Wednesday, March 30, 2016

FDA relaxes mifepristone protocol

Posted By on Wed, Mar 30, 2016 at 12:54 PM

click to enlarge Now the FDA says the lower dosage is acceptable.
  • Now the FDA says the lower dosage is acceptable.
Just a couple of weeks ago, federal Judge Kristine Baker issued a preliminary injunction to keep Arkansas from enforcing its new medical abortion law. The law requires that abortion providers use an old FDA protocol that called for a higher dosage of the abortifacient mifepristone, amounts that caused greater side effects without being more effective than lower dosages. For years, doctors have been prescribing mifepristone at the lower dosage. Apparently, state legislators wanted women to undergo more cramping and nausea if they chose to abort a fetus.

Today, the FDA announced changes in the protocol that would reduce the dosage of the drug, from 600  milligrams to 200, and increases the number of days a woman would be able to use the abortifacient from 49 days to 70 days. That would seem to moot part of the suit, filed by Planned Parenthood of the Heartland against the state.

The New York Times reports that the change would also reduce the number of trips women have to make to a doctor from three to two in most states. The Times called the FDA's move a "victory of abortion rights advocates who  had been fighting laws in states like Texas, North Dakota and Ohio. ... Many doctors say the original labels, based on clinical evidence from the 1990s, were outdated and that the state laws went against accepted medical practice and made it harder for women to get abortions." 

Arkansas's law was overlooked by the Times, apparently. The Planned Parenthood lawsuit is also contesting a provision in the new statute that requires abortion clinics' to contract with doctors who have hospital admitting privileges. 

Here's a statement from the National Women's Health Network.

Statement from Planned Parenthood of the Heartland on the jump.


Statement from PPHeartland:

Today’s announcement from the FDA that a new label for mifepristone has been approved is another affirmation that medication abortion is a safe and effective option to end an early pregnancy. The changes reflect the evidence-based protocols for medication abortion, which have been recognized as “superior” to the regimen on the previous label.

This announcement means that health care providers can provide medication abortion according to the highest standard of care established after more than 15 years of research and experience.

The Arkansas law at the center of PPHeartland’s lawsuit refers to on-label usage of mifepristone, and our practice is in alignment with the FDA-approved label. It’s too early to say what will happen to our ongoing court case. Regardless, we will move forward in our fight against the equally onerous piece of the law that would require us to have an agreement with a backup provider.

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