ADF Alliance Alert

Update:

LifeNews.com reports: Ohio Supreme Court Should Clarify Abortion Drug Law Appeals Court Says.
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Today, the U.S. Court of Appeals for the 6th Circuit issued a ruling in Planned Parenthood Cincinnati Region v. Strickland, Nos. 06-4422/4423 (6th Cir. June 23, 2008).  Ohio adopted a statute (O.R.C. § 2919.123) limiting the use of RU-486 to FDA approved guidelines.  Planned Parenthood seeks to allow expanded “off label” prescriptions of the drug and filed suit challenging Ohio’s statutory restrictions.  The district court enjoined the statute on grounds that it lacked an exception for the health or life of the mother.  The court of appeals held that every abortion statute need not have such an exception, but such an exception was warranted in this case.  It remanded the case to the district court:

. . . for a determination of the proper scope of the preliminary injunction in light of Ayotte, which explained that “we prefer . . . to enjoin only the unconstitutional applications of a statute while leaving other applications in force.” Ayotte, 546 U.S. at 327-28. On remand, Planned Parenthood moved for summary judgment and sought a permanent injunction on the basis that O.R.C. § 2919.123 is unconstitutionally vague. Agreeing with Planned Parenthood, the district court declared the statute void for vagueness and permanently enjoined the entire statute’s enforcement. Planned Parenthood v. Taft, 459 F. Supp. 2d 626, 640 (S.D. Ohio 2006). The State has once again appealed.

In this appeal by the state,  the court of appeals is faced with the following question:

To resolve the issues presented in this case, we must ascertain what O.R.C. § 2919.123 means when it states that physicians who perform abortions using mifepristone must comply with “federal law,” as that term is defined in the statute . . .

According to the State, by including the approval letter in the statute’s definition of “federal law,” O.R.C. §2919.123 effectively prohibits physicians from administering mifepristone to women who are beyond forty-nine days’ gestation and from using a treatment protocol different from that found in the drug’s final printed labeling (i.e., the statute prohibits the off-label use of mifepristone).

Conversely, Planned Parenthood argues that the statute imposes no restrictions on the prescribing practices of physicians  . . .  Planned Parenthood concedes that if its interpretation is adopted, then its claims that the statute is unconstitutional will be rendered moot. However, Planned Parenthood asserts that if the statute is interpreted to mean what the State says it means, then the statute is unconstitutional and was correctly enjoined by the district court.

At this stage in the proceedings, the Sixth Circuit Court of Appeals certifies several questions  to the Ohio Supreme Court.  The questions (bolded) and other excerpts are copied below:

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Absent state regulation, once a drug has been approved by the FDA, doctors may prescribe it for indications and in dosages other than those expressly approved by the FDA. This is a widely employed practice known as “off-label” use. Off-label use does not violate federal law or FDA regulations because the FDA regulates the marketing and distribution of drugs in the United States, not the practice of medicine, which is the exclusive realm of individual states. As a result of this research, an off-label protocol was developed consisting of 200 mg of mifepristone administered orally followed one to three days later by 0.8 mg of misoprostol administered vaginally. This regimen is employed up to sixty-three days’ gestation and is known as the Schaff protocol after the doctor whose research primarily led to its development.

In 2004, the Ohio General Assembly enacted H.B. 126 (“the Act”) to regulate the use of mifepristone in Ohio. Specifically, the Act provides:

No person shall knowingly give, sell, dispense, administer, otherwise provide, or prescribe RU-486 (mifepristone) to another for the purpose of inducing an abortion . . . unless the person . . . is a physician, the physician satisfies all the criteria established by federal law that a physician must satisfy in order to provide RU-486 (mifepristone) for inducing abortions, and the physician provides the RU-486 (mifepristone) to the other person for the purpose of inducing an abortion in accordance with all provisions of federal law that govern the use of RU-486 (mifepristone) for inducing abortions.

Ohio Rev. Code Ann. § 2919.123(A). The Act defines “federal law” as, “any law, rule, or regulation of the United States or any drug approval letter of the food and drug administration of the United States that governs or regulates the use of RU-486 (mifepristone) for the purpose of inducing abortions.” Ohio Rev. Code Ann. § 2919.123(F). This arguably requires doctors who prescribe mifepristone for the purpose of inducing an abortion to do so only in accordance with the indication, regimen and distribution restrictions approved by the FDA. In other words, the Act arguably prohibits the “off-label” use of mifepristone.

According to the State, the Act was passed because abortion providers in Ohio were openly using the Schaff protocol and “because legislators became aware that several women had died or been severely injured recently as a result of their use of mifepristone.” The State further suggests that Ohio legislators concluded that the FDA had only approved one specific protocol for the administration of mifepristone because that was the only safe and effective protocol. Accordingly, the State argues that [it] banned all other uses of mifepristone to protect Ohio women from unsafe and ineffective mifepristone protocols. Taft, 444 F.3d at 505-06.

While Planned Parenthood previously instructed its doctors that mifepristone could be administered up to sixty-three days’ gestation, its instructions now provide that mifepristone only be administered up to fifty-six days’ gestation. Thus, there can be no debate that physicians in Ohio continue to administer mifepristone beyond the FDA-approved use of forty-nine days’ gestation. These doctors also continue to perform medical abortions using doses of mifepristone that are lower than those approved by the FDA . . .

For the reasons set forth above, we certify the following questions of state law to the Supreme Court of Ohio pursuant to Rule XVIII of the Rules of Practice of the Supreme Court of Ohio:

1) Does O.R.C. § 2919.123 mandate that physicians in Ohio who perform abortions using mifepristone do so in compliance with the forty-nine-day gestational limit described in the FDA approval letter?

2) Does O.R.C. § 2919.123 mandate that physicians in Ohio who perform abortions using mifepristone do so in compliance with the treatment protocols and dosage indications described in the drug’s final printed labeling? . . .

For the foregoing reasons, we CERTIFY questions of state law to the Supreme Court of Ohio. It is further ordered that the district court’s injunction against the enforcement of O.R.C. § 2919.123 remain in full force and effect pending further order of this court.

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