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Abortion providers argue Legislature illegally ceding power to drug company

abortion gavelAbortion providers have opened up a second legal front in their bid to block Arizona from restricting the use of medication to terminate pregnancy.

Attorney David Brown of the Center for Reproductive Rights wants Maricopa County Superior Court Judge Richard Gama to rule that legislators violated the Arizona Constitution by essentially giving the manufacturer of RU-486 the unquestioned authority to decide how and when the drug can be used in the state. Brown said that amounts of letting a private company set state law.

is working to convince federal courts that the 2012 law is an unconstitutional infringement on the right of women to an abortion. That law was supposed to take effect April 1 but was stayed by the 9th U.S. Circuit Court of Appeals.

But if Gama agrees with Brown that the statute was illegally enacted, the law goes away – and there is no need by Planned Parenthood and Tucson Women’s Center to pursue the federal case.

At the heart of the issue is the legislative mandate that drugs used to perform abortions in Arizona can be administered only according to the manufacturer’s label as approved by the U.S. Food and Drug Administration.

The label crafted by Roussel Uclaf, the French pharmaceutical subsidiary of Hoechst AG that manufactures the drug, specifically says it is to be used for abortions only during the first seven weeks of pregnancy.

But FDA labeling is not binding on doctors. And physicians in Arizona and elsewhere have used the drug, in different doses and in combination with a second drug, through nine weeks.

This law would leave surgery as the only alternative beyond the seventh week.

Potentially more significant, the measure could be read to outlaw medication abortions outright. That is because a second drug, needed to expel the fetus, is not labeled for use in abortions.

Brown said the legal problem with all that is that lawmakers have effectively punted on their responsibility.

He said the Arizona Constitution requires the Legislature – and only the Legislature – to determine the law. Brown said it also forbids lawmakers from relinquishing their authority.

But what happened here, Brown argues, is that lawmakers simply gave the FDA the power to decide how a drug can be legally used in Arizona.

Brown said it’s even more legally problematic than that.

“A drug label is written not by the FDA, but by a drug company,” he said.

The FDA gets involved only in approving or rejecting the label. And Brown said neither the FDA nor federal law preclude or even discourage the “off-label” use of medications by doctors.

“So, what this law does, is it essentially turns a drug label written by a private company into state law in Arizona,” Brown said.

Beyond that, Brown noted that drug labels can be changed at any time “and often are.”

“Every time a drug label is modified based on the commercial decision of a drug company, Arizona law is modified as well,” he said. Brown said that happens without legislative oversight and “without accountability to this state’s voters.”

And that, he said, violates the requirement that the Legislature set the laws of the state.

“The Arizona Supreme Court has specifically said that it is improper for the Legislature to adopt changeable standards,” Brown said.

Josh Kredit, an attorney for the anti-abortion Center for Arizona Policy, acknowledged that the statute refers to the FDA labeling.

But Kredit, whose organization helped craft the measure, said lawmakers made separate “findings” saying they were interested in adopting the specific dosage in effect in 2012. And he said a judge should consider that the intent of the Legislature.

So far, attorneys for the state have not responded to the lawsuit, at least not to the merits. Instead, the Attorney General’s Office has asked Gama to put the case on the back burner, at least for the time being, while the other lawsuit in federal court plays out.

“Both cases involve the same parties (and) claim the Arizona law is invalid,” Assistant Attorney General Gregory Honig argued in pleadings to Gama. And in both cases, Honig said, the aim of challengers is to permanently block enforcement of the law.

“It makes little sense for two courts to expend the time and effort to achieve an identical resolution of the questions arising under the same facts and involving the identical parties,” the attorney said. And Honig said if federal judges void the law on constitutional grounds, there’s no need for this state court lawsuit.

But Brown said there’s no basis to slow up this case.

“The two issues are completely separate,” he said, with the case before Gama based solely on whether the 2012 statute is illegal under state law.

Anyway, Brown said, the legal wrangling in federal court currently is solely over the question of whether the law should be allowed to take effect while its legality is litigated, a process that could take months or longer. To this point the appellate court has issued only a preliminary stay.

But Brown said there would be a quicker resolution of the whole issue if Gama decides lawmakers acted illegally in delegating their right to regulate RU-486.

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