Cline symposium: Another correction of the abortion distortion coming?

Casey Mattox is Senior Counsel at the Alliance Defending Freedom.

The most basic principles of law become controversial when abortion is at issue. Long before the creation of the Food and Drug Administration, the states exercised the authority to regulate the sale and use of prescription drugs to protect the health and welfare of their citizens. Yet, since Oklahoma regulated the use of a protocol for the abortion drug RU-486, many wish to scrutinize any restriction on its use as a violation of the abortion “right.”

But recent Supreme Court decisions in Ayotte v. Planned Parenthood, Gonzales v. Carhart – and perhaps one later this year in McCullen v. Coakley – have been correcting this abortion distortion. Cline v. Coalition for Reproductive Justice gives the Court an opportunity to further clarify that states maintain their authority to protect the health and safety of their citizens from the dangerous misuse of prescription drugs even where the drug causes abortions.

First is the matter of the law’s scope. The Oklahoma Supreme Court’s dismissive approach to the law – issuing a brief four-paragraph opinion without argument and simply asserting without explanation that the law is “facially unconstitutional pursuant to Casey” – leaves little lower court analysis to review.  Indeed, the Supreme Court found it necessary to take the unusual step of asking the Oklahoma Supreme Court to explain itself.  So before the case arrives back at the U.S. Supreme Court, the Oklahoma Supreme Court will weigh in again, likely sometime later this fall. There should be little doubt about what the law requires.

Helen Alvare explains the import of the certified questions well. Abortion plaintiffs commonly dream up creative interpretations of a challenged statute to make their plight seem worse. But the common sense reading of the statute is that the law simply requires that abortionists use RU-486 as the FDA has approved. It does not forbid all chemical abortions or prohibit the use of drugs to treat ectopic pregnancies. While the Oklahoma Supreme Court’s cursory opinion gives little insight as to its views, it should limit the law’s reach just as the defendants argue and, presumably, as the plaintiffs would prefer. Once that diversion is over, the case will return to the U.S. Supreme Court.

The Oklahoma law simply requires doctors to administer RU-486 “according to the protocol tested and authorized by the U.S. Food and Drug Administration and as authorized in the drug label for the RU-486 (mifepristone) or any abortion-inducing drug.” So to understand the Oklahoma law, one must understand the FDA’s approval of RU-486. The FDA did not merely permit the use of RU-486 before seven weeks. It expressly rejected the off-label uses at issue.

After four years of evaluation, the FDA suddenly rushed to approve RU-486 in 2000, the waning days of the Clinton administration, under a special “fast track” rule. This accelerated process is intended for drugs that “treat a serious or life-threatening disease or condition.”  Hence, drugs treating cancer, AIDS, and similar conditions can get to market more quickly, even before their possible adverse effects have been fully evaluated.  If the FDA has concluded that a drug “can be safely used only if distribution or use is restricted,” it “will require such postmarketing restrictions as are needed to assure safe use of the drug.”  “[H]igh risk drugs that are approved based on postmarketing restrictions would not have been approved for use without those restrictions because the risk/benefit balance would not justify such approval.”

In its letter indicating that it would move forward with approval of RU-486, the FDA explained:

We have concluded that adequate information has not been presented to demonstrate that the drug, when marketed in accordance with the terms of distribution proposed, is safe and effective for use as recommended. The restrictions on distribution will need to be amended.

We have thus considered this application under the restricted distribution regulations contained in 21 CFR 314.500 (Subpart H) and have concluded that restrictions as per CFR 314.520 on the distribution and use of mifepristone are needed to assure safe use of this product.

The FDA’s September 2000 approval letter is also adamant that the drug is approved “with restrictions to assure safe use.” Approval was only “for the medical termination of intrauterine pregnancy through 49 days’ pregnancy.” The FDA also expressly rejected the sponsor’s suggestion that the label include information on self-administering misoprostol at home. The approved label states that a “wom[a]n should not take Mifeprex” if “[i]t has been more than 49 days (7 weeks) since your last menstrual period began.” “It is not approved for ending later pregnancies.

The FDA required that the patient sign an agreement, attesting (in part):

“I believe I am no more than 49 days (7 weeks) pregnant;”

“I will take misoprostol in my provider’s office two days after I take Mifeprex (Day 3)”;

“I will…return to my provider’s office in 2 days (Day 3) to check if my pregnancy has ended. My provider will give me misoprostol if I am still pregnant”; [and]

“I will…return to my provider’s office about 14 days after beginning treatment to be sure that my pregnancy has ended and that I am well.”

The abortionist must also sign this patient agreement, attesting that the patient “signed the Patient Agreement in my presence.” The FDA required an audit of these agreements to ensure they were being signed.

Over a decade has passed, but the FDA has never concluded that any other regimen would provide the assurance of safe use necessary for approval. Thus, the FDA continues to identify the regimen outlined in the Mifeprex label as the only “approved” use. It has warned: “FDA is aware that medical practitioners may be using modified regimens.… [T]he safety and effectiveness of Mifeprex dosing regimens, other than the one approved by FDA…has not been established by the FDA.”

The FDA’s caution in refusing to authorize other regimens for RU-486 has unfortunately been validated. While reporting of adverse events from RU-486 – or any drug – is incomplete, as of 2011 there were eight known deaths from RU-486 in its first decade of use, all of which were from off-label uses. And because often no prior doctor-patient relationship exists between the abortionist and patient and one of the common off-label uses is for a woman to self-administer the protocol at home and not return for any follow-up examination, off-label use of RU-486 may have hurt or killed many more women than physicians’ reports to the FDA have accounted for.

The Oklahoma legislature relied upon this well-developed body of medical knowledge about RU-486 in requiring that its use within its borders be limited to the FDA’s required protocol.

Applying its holding in Gonzales, the Court should defer to the legislature’s judgment in protecting the health and safety of Oklahomans. In fact, the Court should be even more deferential to the Oklahoma legislature here. In Gonzales, Congress itself was making medical judgments between conflicting experts. Here, the Oklahoma legislature is fully supported by and deferred to the findings and judgments of the FDA.

The Court should then have no difficulty concluding that the law imposes no “undue burden” to obtain an abortion under Planned Parenthood v. Casey. Chemical abortion would remain available as approved by the FDA, up to seven weeks, and surgical abortion would remain available both before and after that period. As Gonzales confirms, there is no constitutional right to one’s choice of abortion method. For nearly thirty years, surgical abortion was virtually the only option for inducing an abortion. If the lack of availability of a chemical abortion was an “undue burden,” it was one nature and science imposed. It would be odd for the Court to hold that it is an undue burden to enforce the FDA’s conclusion that RU-486 is not safe enough for use in the narrow window between the seventh and ninth weeks of gestation – especially where abortionists would remain free to use the same surgical methods that existed when the undue burden standard was created.

The Court might also consider it relevant to the undue burden analysis that abortionists have another recourse. If abortionists are confident that their off-label use of RU-486 is safe and effective, they can petition the FDA to change the label. If they succeed, those uses would be permitted in Oklahoma under the Act.

As the Court observed in Robinson v. California:

There can be no question of the authority of the State in the exercise of its police power to regulate the administration, sale, prescription and use of dangerous … drugs. The right to exercise this power is so manifest in the interest of the public health and welfare, that it is unnecessary to enter upon a discussion of it beyond saying that it is too firmly established to be successfully called in question.

In Cline, the Supreme Court can and should affirm that states have the authority to ensure that abortion drugs, like other drugs, are used safely and that enforcing the FDA’s own requirements about a drug’s use is a perfectly reasonable exercise of that authority.