Cordray v. Planned Parenthood Cincinnati RegionCordray v. Planned Parenthood Cincinnati Region
Lead Opinion
{¶ 2} “1) Does O.
{¶ 3} “2) Does O.
{¶ 4} The plain language of
Facts and Procedural History
{¶ 5} In March 1996, the Population Council sponsored a new drug application with the Food and Drug Administration (“FDA”) “for the use of [mifepristone] for the medical termination of intrauterine pregnancy through 49 days’ pregnancy.” In evaluating the safety and efficacy of mifepristone (a drug also known as “RU-486” and its trade name “Mifeprex”) for inducing abortions, the FDA relied on clinical trials involving women with gestational durations of 49 days or less who took 600 mg of mifepristone followed in most cases by a dose of 400 |xg of misoprostol two days later. In issuing its September 28, 2000 drug approval letter approving use of mifepristone, the FDA concluded that “adequate information has been presented to approve [mifepristone] for use as recommended in the agreed upon labeling text.”
{¶ 6} Further, in its drug approval letter, the FDA, pursuant to 21 C.F.R. 314.520, imposed an additional restriction that mifepristone “be provided by or under the supervision of a physician who meets the following qualifications:
{¶ 7} “[1.] Ability to assess the duration of the pregnancy accurately.
{¶ 8} “[2.] Ability to diagnose ectopic pregnancies.
{¶ 9} “[3.] Ability to provide surgical intervention in cases of incomplete abortion or severe bleeding, or have made plans to provide such care through other qualified physicians, and are able to assure patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary.
{¶ 11} “[5.] Must provide each patient with a Medication Guide and must fully explain the procedure to each patient, provide her with a copy of the Medication Guide and Patient Agreement, give her an opportunity to read and discuss both the Medication Guide and the Patient Agreement, obtain her signature on the Patient Agreement and must sign it as well.
{¶ 12} “[6.] Must notify the sponsor or its designate in writing as discussed in the Package Insert under the heading DOSAGE AND ADMINISTRATION in the event of an ongoing pregnancy, which is not terminated subsequent to the conclusion of the treatment procedure.
{¶ 13} “[7.] Must report any hospitalization, transfusion or other serious events to the sponsor or its designate.
{¶ 14} “[8.] Must record the [mifepristone] package serial number in each patient’s record.”
{¶ 15} The FDA labeling text referred to in the drug approval letter states, “Mifepristone is indicated for use in the termination of pregnancy (through 49 days’ pregnancy) and has no other approved indication for use during pregnancy.” (Emphasis added.) It also explains that treatment with mifepristone requires three office visits by the patient. On day one, the patient takes a single oral dose of 600 mg of mifepristone. On day three, the patient returns to the provider for an oral dose of 400 pug of misoprostol, unless the physician confirms that the abortion has already occurred. On day 14, the patient again returns for a follow-up visit to ensure that termination of the pregnancy has occurred.
{¶ 16} The FDA-mandated final printed labeling also includes a “Patient Agreement” that requires the patient to affirm that she “believe[s] [that she is] no more than 49 days (7 weeks) pregnant” and a “Prescriber’s Agreement” by which the physician is to indicate that he has met the qualifications for providing mifepristone imposed by the drug approval letter and to agree to administer the drug consistently with listed guidelines.
{¶ 17} Since issuing the drug approval letter in September 2000, the FDA has revised it and has twice revised the labeling text for mifepristone. However, none of those revisions or any other action of the FDA has altered the 49-day gestational limitation for administration of mifepristone or modified any of the dosage indications or treatment protocols originally approved by the FDA.
{¶ 18} In general, after the FDA approves a drug for use and absent any state regulation to the contrary, doctors may prescribe that drug for indications, in dosages, and following treatment protocols different from those expressly approved by the FDA in its approval letter, a practice commonly known as “off-
{¶ 19} In 2004, the Ohio General Assembly enacted
{¶ 20} Prior to the effective date of
{¶ 21} The district court determined that Planned Parenthood had shown a strong likelihood of success on the merits of its claim that
{¶ 22} On remand, Planned Parenthood moved for a summary judgment and sought a permanent injunction on the basis that
Propositions of Law
{¶ 23} In this court, the Ohio Attorney General contends that the plain language of
{¶ 24} According to Planned Parenthood, neither the FDA’s approval letter nor any other provision of federal law prohibits abortion providers from using mifepristone to induce abortions beyond the 49th day of pregnancy or from following any evidence-based regimens for administering mifepristone not expressly approved by the FDA. Because the FDA regulates the marketing and distribution of drugs, not the practice of medicine, the approval letter does not “govern” or “regulate” a physician’s off-label use of mifepristone. Planned Parenthood further argues that the General Assembly could expressly prohibit the off-label use of drugs approved by the FDA, as it did in the case of certain anabolic steroids. It maintains that the General Assembly chose not to prohibit the off-label use of mifepristone but instead codified the physician-qualification,
{¶ 25} We are therefore called upon to interpret the scope and meaning of
Law and Analysis
{¶ 26} In construing
Statutory Restriction on the Use of Mifepristone
{¶ 27} The provisions of
{¶ 28} In approving mifepristone for use, the FDA imposed postapproval restrictions “to assure safe use of the drug product” pursuant to its authority under 21 C.F.R. 314.520. In its brief, Planned Parenthood admits that “the FDA, in its Approval Letter, imposed * * * restrictions on physicians who dispense mifepristone,” explaining that mifepristone “must be provided by or under the supervision of a physician who meets” the qualifications that appear in the drug approval letter. These qualifications govern and regulate the use of mifepristone to induce abortions by mandating that physicians who do not meet these
Administration of Mifepristone in Accordance with the FDA Approval Letter
{¶ 29} A physician provides mifepristone in accordance with the drug approval letter by administering the drug in conformity with the medical regimen approved by the FDA in that letter.
{¶ 30} The FDA drug approval letter states that the “new drug application provides for the use of [mifepristone] for the medical termination of intrauterine pregnancy through 49 days’ pregnancy.” The FDA concluded on review of the application that “adequate information has been presented to approve [mifepristone] for use as recommended in the agreed upon labeling text.” Thus, the FDA based its approval of mifepristone on its use as recommended in the labeling text, thereby incorporating that text into its letter of approval. The FDA labeling text specifically provides that “[m]ifepristone is indicated for use in the termination of pregnancy (through 49 days’ pregnancy) and has no other approved indication for use during pregnancy.” The drug approval letter and the labeling text indicate that the FDA approved the use of mifepristone for use through, but not beyond, the 49th day of pregnancy (“dated from the first day of the last menstrual period”). Administering mifepristone to induce an abortion beyond the 49th day of pregnancy would not be in accordance with the drug approval letter.
{¶ 31} Similarly, the drug approval letter, by incorporating the labeling text, provides a specific dosage indication and treatment protocol: 600 mg of mifepristone, taken orally, followed when necessary by an oral dose of 400 |xg of misoprostol two days later. Using any other dosage indication or treatment protocol would not be in accordance with the drug approval letter.
{¶ 32} Therefore,
{¶ 33} Planned Parenthood argues that a physician has the authority to prescribe a drug for off-label use in the practice of medicine. Off-label use is defined by the federal courts as the prescription of drugs for indications, in dosages, and following treatment protocols different from those expressly approved by the FDA. Planned Parenthood Cincinnati Region v. Strickland,
{¶ 34} Other drugs have been similarly restricted in Ohio. See
(¶ 35} Thus, pursuant to
Conclusion
{¶ 36} The Ohio Constitution vests the General Assembly, and not this court, with the legislative powers of government. Our role, in exercise of the judicial power granted to us by the Constitution, is to interpret the law that the General Assembly enacts. Because we conclude that the plain language of
So answered.
Concurrence Opinion
concurring in part and dissenting in part.
{¶ 37} I concur in the court’s judgment that
A
{¶ 38}
{¶ 39} 1. The drug must be administered by a qualified physician.
{¶ 40} 2. The physician must provide each patient with a Medication Guide and Patient Agreement.
{¶ 41} 3. The physician must fully explain the procedure to each patient.
{¶ 42} 4. The physician must give the patient an opportunity to read and discuss both the Medication Guide and the Patient Agreement.
{¶ 43} 5. The physician must obtain the patient’s signature on the Patient Agreement and must sign it as well.
{¶ 44} The Patient Agreement requires the patient to certify that she believes that she is no more than 49 days pregnant. In requiring a patient to sign the
B
(¶ 45} Despite agreeing that the FDA has limited the use of mifepristone and that the General Assembly has enacted that limitation into law, I dissent from the majority’s conclusion that
{¶ 46}
{¶ 47} It is well accepted that after the FDA approves a drug for use, doctors may prescribe the drug for off-label uses. 12 FDA Drug Bulletin (Apr. 1982) 4, quoted in Weaver v. Reagen (C.A.8, 1989),
{¶ 48} The law recognizes that medical judgments are best left to the sound discretion of those with the education, training, and experience to make the best-informed decisions- — physicians. “Good medical practice and the best interests of the patient require that physicians use legally available drugs, biologies and devices according to their best knowledge and judgment.” United States Food and Drug Administration, Information Sheet: Guidance for Institutional Review Boards and Clinical Investigators 1998 Update, available at http://www.fda.gov/oc/
{¶ 49} Because the FDA’s approval of the use of mifepristone within the 49-day gestational limit does not prohibit off-label use of the drug, other uses are also in accordance with federal law. If the legislature intended to forbid all off-label uses of mifepristone, it could have expressly done so. Instead, it limited the use of the drug to those uses that are in accordance with federal law. Thus, I would hold that although
Dissenting Opinion
dissenting.
{¶ 50}
{¶ 51} First, and obviously, the plain language of
{¶ 52} Second, federal law does not specifically limit the use of mifepristone, because the FDA does not regulate the practice of medicine. Southard v. Temple Univ. Hosp. (2001),
{¶ 53} The drug-approval letter in this case, which is defined by
{¶ 54} Third, the General Assembly could have specifically banned the off-label use of mifepristone, as it banned particular off-label uses of certain steroids. See
{¶ 55} Nothing in the plain language of