Opinion ID: 2746137
Heading Depth: 1
Heading Rank: 1

Heading: FDA Label Provision

Text: [¶77] The State argues H.B. 1297 does not create a de facto ban on medication abortions. This argument is based upon the State’s proposition that the plain language of H.B. 1297’s definitions of “abortion” and “abortion-inducing drug” allow for a reading under which mifepristone is classified as an abortion-inducing drug and misoprostol is not. This scenario could exist if “abortion” meant only the detachment of the fetus from the uterine lining, and not the expulsion of the fetus from the uterus. However, the definition of abortion includes the prescription of medicine, drug, or any other substance with the intent to terminate the intrauterine pregnancy of a woman. Section 1 of H.B. 1297 specifically excludes from the definition of abortion the use or prescription when the intent is to “[r]emove a dead unborn child caused by spontaneous abortion.” This exclusion would not be necessary if the expulsion of an already detached fetus were not included in the statutory definition of abortion. [¶78] Section 6 of H.B. 1297 requires that an “abortion-inducing drug” be administered in a manner that “satisfies the protocol tested and authorized by the federal food and drug administration and as outlined in the label for the abortion- inducing drug.” Misoprostol has not been separately approved by the FDA for use in medication abortion procedures. However, the FDA label protocol specifies the use of misoprostol in conjunction with mifepristone. The evidence in this case is that mifepristone alone accomplishes an abortion, including the expulsion of the fetus from the uterus, in only about seven percent of the cases. Misoprostol is necessary to complete the abortion process in about ninety-three percent of the cases. Thus, under our reading of the definitions of “abortion” and “abortion-inducing drug,” the FDA label provision of H.B. 1297 necessarily operates as a de facto ban on medication abortions under current medical practices, at least until such a time as misoprostol is separately approved by the FDA for use in abortions or our statute is amended. [¶79] For those women for whom a surgical abortion is not a possibility and for those women who are between 49 and 63 days past their last menstrual period, H.B. 1297 also operates as a complete ban despite the evidence presented at trial that the protocol developed using mifepristone and misoprostol is a safe and effective option for terminating an early pregnancy. [¶80] When H.B. 1297 requires that medication abortions follow the FDA label protocol and that protocol includes the use of both mifepristone and misoprostol, it is unclear from the legislation whether both were intended as abortion-inducing drugs. It is, however, clear that any use of misoprostol that varies from the FDA label would subject a physician to criminal liability. Since the evidence establishes that the current standard of care for medication abortion varies from the FDA label, the legislation operates as a de facto ban as found by the district court.