Ohio Supreme Court Backs State Regulation of Abortion-Inducing Drug
July 7, 2009 - 8:28 AMPro-life groups are hailing last week's ruling from the Ohio Supreme Court, which said abortion providers such as Planned Parenthood must strictly comply with FDA rules for administering the abortion-inducing drug mifepristone, also known as RU 486.
Planned Parenthood challenged a 2004 Ohio law requiring that the abortion pill be restricted to women who are no more than 49 days’ pregnant.
The Ohio law says abortionists must abide by the rules approved by the FDA when it first made RU-486 available in the United States in September 2000.
The FDA’s approval of RU-486 was based on clinical trials in which patients whose pregnancies had advanced no longer than 49 days received an oral dose of 600 mg of RU-486, followed two days later by an oral dose of 0.4 mg of misoprostol.
According to the Ohio Supreme Court, Planned Parenthood clinics in Cleveland, Columbus and Cincinnati were prescribing RU-486 “off label,” using different dosages for patients whose pregnancies had progressed as long as 63 days.
While off-label usage of RU-486 is not barred by federal law or FDA regulations, it is barred by the 2004 Ohio state law, pro-life groups argued.
Dr. Charmaine Yoest, president and CEO of Americans United for Life, applauded the Ohio Supreme Court “for cutting through Planned Parenthood's self-serving rhetoric that it did not need to follow the protocol tested and approved by the FDA when administering RU-486.” She said the court has told Planned Parenthood it is not above the law.
"The fact that Planned Parenthood readily admits to routinely disregarding the FDA-approved protocol and actually argued it was entitled to dispense RU-486 in an untested and dangerous manner is appalling,” AUL Staff Counsel Mailee Smith said. “It is further confirmation that Planned Parenthood is not the protector of women's health and welfare it holds itself out to be."
Planned Parenthood argued the Ohio law was unconstitutional and that its requirements were unclear.
The State of Ohio and AUL argued that the Ohio law is definitive in its requirement that abortionists can use the RU-486 drug regimen only in the way in which it was tested and approved by the FDA, as is clearly laid out in the manufacturer's label that accompanies the drug.
“The provisions of R.C. 2919.123 (the Ohio law) are not ambiguous,” Justice Terrence O’Donnell wrote in the Ohio Supreme Court’s majority decision. “Administering mifepristone to induce an abortion beyond the 49th day of pregnancy would not be in accordance with the drug approval letter,” he wrote.
The Ohio Supreme Court’s 4-3 ruling on July 1 does not address the constitutionality of the state law. It only interprets that language of the Ohio statute in response to a request by the U.S. Sixth Circuit Court of Appeals.
The case will now return to the Sixth Circuit Court of Appeals for a decision on whether the statute, as interpreted by the Ohio Supreme Court, is constitutional.