FDA Attitude on Off-Label Prescribing Central to Arizona Abortion Drug Access Case

Regulatory NewsRegulatory News | 04 June 2014 |  By 

A federal court has ruled that Arizona's attempts to limit access to an abortion drug known as RU-486 (mifepristone) are unconstitutional, drawing on the US Food and Drug Administration's (FDA) authority to support its ruling.


The case involved Arizona's attempts to restrict the use of RU-486, which is approved by FDA for use in terminating pregnancy within 49 days of the start of a woman's last menstrual period. As FDA explains on its website, the approved regimen for use is as follows:

  • Day One: Mifeprex Administration: 3 tablets of 200 mg of Mifeprex orally at once
  • Day Three: Misoprostol Administration: 2 tablets of 200 mcg of misoprostol orally at once
  • Day 14: Post-Treatment: The patient must return to confirm that a complete termination has occurred.  If not, surgical termination is recommended to manage medical abortion treatment failures.

"The safety and effectiveness of other Mifeprex dosing regimens, including use of oral misoprostol tablets intravaginally, has not been established by the FDA," the agency wrote. The drug has been associated with dozens of serious adverse events, including deaths, though FDA has not determined a causal connection between the drug and the deaths.

The drug is often used in combination with misoprostol, a drug which causes the uterus to go into labor, but it is not approved for any other purpose except for the treatment of stomach ulcers. Its labor-inducing properties are thus "off-label," meaning they are carried out without the explicit approval of FDA. Off-label prescribing is permitted by FDA, however.

Arizona Limits

Apparently hoping to limit access to abortion services, Arizona legislators in 2012 passed into law a measure that would restrict access to the drug in cases where it was being used off-label, such as during a period of time later than 49 days after the start of a woman's last menstrual period.

The key passage of the law is as follows:

"The director [of the Arizona Department of Health Services] shall adopt rules relating to the abortion procedure. At a minimum these rules shall require . . . [t]hat any medication, drug or other substance used to induce an abortion is administered in compliance with the protocol that is authorized by the FDA and that is outlined in the final printing labeling instructions for that medication, drug or substance." (Emphasis Added)

Eventually, Planned Parenthood filed a lawsuit against the state, which resulted in a hearing before the California 9th Circuit Court of Appeals in the case, Planned Parenthood v. Humble.

A central point of debate in the case is whether FDA permits the off-label prescribing of drugs, or simply tolerates it. The court found that the agency has actively permitted the practice since at least 1982, noting that the agency sees it as an essential part of the ecosystem of medical innovation.

"Such ‘unapproved’ or, more precisely, ‘unlabeled’ uses may be appropriate and rational in certain circumstances, and may, in fact, reflect approaches to drug therapy that have been extensively reported in medical literature," FDA wrote in a 1982 drug bulletin.

Court Decision

The court's decision ultimately rested on two measures: Whether the law unduly infringed upon a woman's right to an abortion—something Focus won't get into—and whether the State's attempt to limit use of mifepristone serves any legitimate purpose.

The court found that based on the evidence provided, the state of Arizona did not have any compelling reasons to ban off-label use of the drug, finding that it unduly burdened patients without offering a legitimate benefit.

The court wrote:

"Arizona argues that the law prohibits not just safe evidence-based regimens for medication abortion but also other, dangerous off-label regimens. But the record contains no evidence that any such dangerous regimen exists or has ever been used by any abortion provider. Therefore, on the current record, the Arizona law appears wholly 'unnecessary as a matter of women's health.'"

Based on those factors, the court ruled that the plaintiffs, Planned Parenthood of Arizona, had a "likelihood of success" in their case, and ordered a lower court to issue a preliminary injunction against the law taking effect.

The decision notably did not make any determination as to whether federal law preempted Arizona's attempts to ban off-label prescribing, leaving it as a potentially viable option for other states considering it as a tool, such as to limit off-label prescribing of painkillers.


Planned Parenthood v. Humble


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