Abortion Law Lawsuit
Tue March 11, 2014
What the FDA Drug Guidelines Say in Texas' New Abortion Law
Texas’ new abortion law requires doctors to follow a specific, federally approved protocol for abortions performed using drugs, in place of a more common method.
The requirement is at issue in a case challenging the Texas law. So what exactly does the law require doctors to do?
Doctors usually have two choices for what are called medication abortions: They can follow a protocol approved by the Food and Drug Administration, or they can follow a different one based on newer scientific studies. But now in Texas, doctors are required to follow the FDA protocol.
The Fifth U.S. Circuit Court of Appeals is deciding whether that requirement is constitutional.
"We went from a procedure that’s done in an outpatient setting where a woman takes medication that causes her to pass the pregnancy at home, to requiring a woman to come in for four different visits, face-to-face with the physician," says Amy Hagstrom Miller, president of Whole Woman’s Health, which offers reproductive health and abortion services in Texas. "We’ve also required that the procedure only be offered to seven weeks, where we used to offer it to women up to nine weeks."
Those face-to-face follow-ups are in line with FDA protocol.
"Keep in mind that an FDA label is based on the information presented to the FDA at the time of approval," says Dr. Mitchell Creinin, head of the Department of Obstetrics and Gynecology at the University of California, Davis. He’s also involved in drawing up guidelines for obstetricians and gynecologists who perform medication abortions. The newest guidelines came out this month, from the American Congress of Obstetricians and Gynecologists and the Society of Family Planning.
"The FDA label that is based on a very, very old regimen consists of mifepristone, the first drug, three tablets," Creinin says. "So 600 milligrams, followed two days later by misoprostol, the second drug, being given as two tablets, or 400 micograms, orally."
An FDA spokesperson explained by email that the FDA doesn’t make any changes to a label on its own initiative. The drug company does lab testing on the safety and effectiveness of the drug and the FDA reviews the results to give its approval. Off-label treatments aren’t regulated by the FDA, and they aren't against federal law.
On its website, the agency writes that the doctor has the "responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence."
Creinin says before the FDA label came out, most physicians in the U.S. were going by the off-label regimen. That's "because we knew that giving a lower dose of mifepristone was better," he says. "Giving the second drug misoprostol in a higher dose, but [vaginally and] not orally, actually has less side effects and worked better."
Recently, the U.S. Supreme Court dismissed a case over an Oklahoma law that would have banned medication abortions all together, allowing the state law to be invalidated. Starting April 1, doctors in Arizona will have to follow the FDA label, although a lawsuit has been filed to block that law.
A federal appeals court is expected to decide on the Texas law later this year. No matter the outcome, it’s expected to be appealed to the U.S. Supreme Court.