Supreme Court Declines to Hear Case on Off-Label Prescribing Authority

Posted 15 December 2014 By Alexander Gaffney, RAC

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The US Supreme Court has refused to hear a challenge to an Arizona law that sought to limit the use of an abortion drug, avoiding a potential showdown over whether off-label prescribing is explicitly allowed under federal law, or simply tolerated.

Background

As Regulatory Focus has previously reported, the Supreme Court had been petitioned to hear an appeal of the federal court case Planned Parenthood v. Humble—a case challenging a 2012 Arizona law which makes it illegal to use the drug RU-486 (mifepristone) for uses not explicitly approved by the US Food and Drug Administration (FDA).

The drug is presently FDA-approved for the termination of 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 drug is often used in combination with misoprostol, a drug which causes the uterus to go into labor. However, misoprostol is not approved for any other purpose except for the treatment of stomach ulcers. Its labor-inducing properties are thus "off-label," meaning its use lacks the explicit approval of FDA.

For more information about Planned Parenthood v. Humble, please see our previous coverage here.

Potential Regulatory Issues

On one hand, the case of Planned Parenthood v. Humble revolves around a seemingly simple question: Is Arizona's proposed ban on the off-label use of RU-486 illegal?

But peel away the layers of the case, and what becomes clear is that the case is also about something else: Federal preemption and FDA's authority to regulate. A central point of debate in the case is whether FDA permits the off-label prescribing of drugs, or simply tolerates it.

A lower court found that FDA 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.

If the federal government was found to lack the authority to regulate off-label prescribing, that would allow states to ban the off-label use of certain products, including abortion drugs and painkillers, which are often used that way.

Lower courts had skirted around this issue, but the Supreme Court, if it agreed to hear the case, might well have considered its merits when considering the case.

Court Declines to Hear Case

But for now, the issue will not be heard. On Monday, 15 December 2014, the Supreme Court without comment declined to hear an appeal of Planned Parenthood v. Humble, leaving in place an earlier ruling by California's 9th Circuit Court of Appeals that struck down the law as "wholly unnecessary."

 

Supreme Court Denial

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Categories: Drugs, Labeling, News, US, FDA

Tags: Supreme Court, SCOTUS, Planned Parenthood v. Humble, Court Case, Off-Label Prescribing

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