Off-Label Is Off The Docket: Supreme Court Leaves RU-486 Flexibility Intact
This article was originally published in The Pink Sheet Daily
Executive Summary
High court declines to intervene in dispute over Arizona law that would restrict use of abortion drug; court also denies Roche petition for review of Boniva patent ruling.
Arizona has failed to block use of the abortion pill Mifeprex (mifepristone), known as RU-486, by mandating that its administration follow the exact protocol set forth in FDA-approved labeling.
On Dec. 15, the Supreme Court denied the state’s petition requesting review of a ruling that blocked implementation of the law. In Humble v. Planned Parenthood Arizona Inc., the director of the Arizona Department of Health Services asked the court to address when an abortion regulation creates an undue burden and is invalid.
The U.S. Court of Appeals for the Ninth Circuit granted Planned Parenthood’s request for a preliminary injunction, finding that the group was likely to succeed in showing that the Arizona law unduly burdens women seeking abortion.
FDA approved Danco Laboratories’ Mifeprex in 2000. States subsequently passed legislation to restrict access by attempting to prevent physicians from prescribing it for off-label uses, i.e., according to a treatment regimen differing from that used in clinical trials supporting the new drug application (Also see "RU-486 Under Attack: Abortion Groups Sue States To Restrict Off-Label Use" - Pink Sheet, 8 Dec, 2008.).
In contrast to other protocols that have been used with the drug, FDA’s approved labeling permits use of the drug through the seventh week of pregnancy rather than the ninth week; requires a lower dosage of misoprostol and a higher dosage of mifepristone, a second drug used to induce abortion; and requires that the patient return to the clinic to take the second drug.
In its opposing brief to the court, Planned Parenthood Arizona said that by the time mifepristone was approved, studies showed that a protocol different from the one that appears on the mifepristone label was superior and could be safely and effectively used for up to nine weeks rather than seven.
“Therefore, the overwhelming majority of the more than two million American women who have safely used mifepristone to terminate an early pregnancy have followed an ‘evidence-based’ protocol different from the one on the mifepristone label,” the filing states.
Court Lets ‘Undue Bruden’ Opinions Stand
Planned Parenthood also argued that the law would likely force the only abortion provider in northern Arizona to stop offering abortions as it can only offer medical abortion. It said that women in that part of the state would have to travel hundreds of miles to access surgical abortion, and would have to make the trip twice since Arizona law imposes a mandatory waiting period.
Arizona asserted that there is a split in the circuit courts as to when an abortion regulation creates an undue burden. It said that the Fifth and Sixth Circuits have found such a burden exists only when a law “erects a substantial obstacle to obtaining a previability abortion” while the Ninth Circuit found that the burden exists when it outweighs the state’s justification for the law.
As for why the court denied cert, Scotusblog journalist Lyle Denniston noted on a Dec. 15 live blog that a good guess is that the court is satisfied with its past statements on what constitutes an undue burden. He said the split on this standard is not sufficient to bring up in an RU-486 case.
A similar battle was waged in Oklahoma when the governor signed a bill into law that would have required physicians to administer RU-486 according to the protocol in the label. The Oklahoma Supreme Court found that the legislation is unconstitutional under the Supreme Court’s 1992 ruling in Planned Parenthood v. Casey (Also see "Pharma Strikes Out At Supreme Court As Three Recent Cert Petitions Fail" - Pink Sheet, 16 Dec, 2013.).
Last year the Supreme Court granted a petition to hear the case, Cline v. Oklahoma Coalition for Reproductive Justice, but then dismissed the petition as improvidently granted after the Oklahoma Supreme Court said the law would ban virtually all medial abortions.
Oklahoma, Nebraska, South Carolina, Alaska, Idaho, Montana, Michigan and Texas jointly submitted an amicus brief in support of Arizona. A group of 38 Arizona legislators also submitted an amicus brief backing the state’s petition.
Court Declines To Hear Roche’s Boniva Patent Case
The Supreme Court also denied Roche’s petition to review a ruling by the U.S. Court of Appeals for the Federal Circuit that once monthly administration of 150 mg Boniva (ibandronate) to treat osteoporosis is obvious in light of prior art.
The case, Hoffmann-La Roche Inc. v. Apotex Inc., addressed whether factual inquiries underlying patent validity may be resolved by the court of appeals or the Federal Circuit must remand the case to have the district courts address these questions.
The question is being addressed in another case pending before the Supreme Court, Teva Pharmaceuticals USA Inc. v. Sandoz Inc., involving a Capoxone (glatiramer) patent dispute. At issue is whether the Federal Circuit should defer to district court decisions on the meaning of patent terms that involve factual findings, such as those based on expert testimony (Also see "Copaxone Supreme Court Case Could Cut Relitigation Of Patent Claims" - Pink Sheet, 13 Oct, 2014.).
The Supreme Court heard oral arguments in October and a decision is expected soon, perhaps when it next issues orders on Jan. 12.