RU-486 Under Attack: Abortion Groups Sue States To Restrict Off-Label Use

Eight years after FDA approved RU-486, two states have engaged in a legal battle to restrict patient access by attempting to prevent physicians from prescribing the abortion pill for off-label uses.

In Ohio, a legal battle has ensued over a 2004 law that requires physicians prescribing RU-486, the common name for Danco Laboratories' Mifeprex (mifepristone), to follow the treatment regimen used in clinical trials in the new drug application. Oklahoma enacted a similar law in April.

The central issue in the Ohio case is whether physicians can prescribe RU-486 for two unapproved uses: taking the drug an additional seven days after becoming pregnant, and taking one-third of the approved dose.

Planned Parenthood of Cincinnati filed a lawsuit to block the law, arguing it was vague and imposed an undue burden on a woman's right to an abortion.

While abortion rights are central to the fight over use of RU-486, the group says the law could have a broader impact on off-label uses for other prescription drugs. "The larger implication is that the state is banning off-label use," said Helene Krasnoff, an attorney with Planned Parenthood.

RU-486 is most commonly prescribed at a dose of 200 mg, versus the labeled 600 mg dose. Planned Parenthood also offers the drug up to 56 days after the first day of the last menstrual period, compared to the 49-day gestational period in the clinical trials.

In Oklahoma, a similar law was to go into effect Nov. 1, but the Center for Reproductive Rights filed suit against the governor and attorney general of Oklahoma and won a temporary restraining order. A district judge blocked the law's implementation until at least March 27, 2009.

FDA Approval Letter Is A Factor

The Planned Parenthood lawsuit against the attorney general of Ohio is now before the state's Supreme Court.

The court is to address two specific questions: (1) does the law mandate that physicians in Ohio using mifepristone do so in compliance with the 49-day gestational limit set forth in FDA's approval letter?; and (2) must they do so in compliance with the treatment protocols and dosage indications on the drug's final printed labeling?

Planned Parenthood asked the court to modify those questions, arguing that FDA's September 2000 approval letter for RU-486 does not require physicians to comply with a gestational limit.

"While the approval letter notes that the new drug application provides for the use of mifepristone through 49 days of pregnancy, it does not 'limit' the approval of mifepristone to usage only within this timeframe," Planned Parenthood states in its brief.

"Indeed, a physician who prescribes mifepristone after 49 days gestation is still 'in compliance' with all FDA rules."

Ohio Says It Can Prohibit Off-Label Use

The central issue in the case is not whether FDA restricted the use of the drug, but whether the Ohio law's incorporation of the approval letter means that the state can restrict physician prescribing to the conditions outlined in the letter.

"It's our position, established by Supreme Court precedent, that states have a right to regulate the practice of medicine," said Ohio assistant attorney general Anne Strait.

While Strait acknowledged that the Food, Drug and Cosmetic Act does not prohibit off-label use, she said "that doesn't mean the states, as part of their regulation of medicine," cannot place restrictions on unapproved indications.

Ohio Attorney General Nancy Rogers makes this argument in a brief to the court. "Once the federal government has found that a drug is safe for one use, its job is done and the states are then free to allow or prohibit other uses - and here, that is exactly what Ohio has done," she stated.

"Ohio has decided that, in the interests of women's health and safety, this drug should be used only in the way that the FDA approved, and not for off-label uses."

In 2004, the federal district court issued a preliminary injunction against the Ohio law finding that Planned Parenthood was likely to succeed on its claim that the law lacked a constitutionally required exception for the life or health of the woman.

On appeal, the Sixth Circuit U.S. Court of Appeals found that the lower court erred in determining that every abortion statute must contain an exception for the life or health of the woman. It sent the case back to the district court for a determination on the proper scope of the preliminary injunction.

Planned Parenthood then moved for summary judgment and sought a permanent injunction on the basis that the law is unconstitutionally vague. The district court agreed and permanently enjoined enforcement of the statute.

The state appealed and the Sixth Circuit then asked the Ohio Supreme Court to answer the two questions on the meaning of the state law. Once the court rules on these questions the case will go back to federal court.

Ohio and Oklahoma are the first states to pass legislation regulating the administration of RU-486; states have previously adopted rules on the use of other drugs, including anabolic steroids, diet pills and narcotic pain medicines.

In the case of RU-486, the politics surrounding abortion are at the center of the battle over access. Indeed, 10 Republican House members jumped into the fray, announcing their support for an amicus brief filed by Americans United for Life in support of the Ohio attorney general.

"The state of Ohio is well within its rights and acting in the interests of its people in seeking to ensure the FDA standards are fully enforced for this deadly drug, which should never have been legalized in the first place," Rep. John Boehner, R-Ohio, stated in a press release.

The Center for Reproductive Rights views the Oklahoma law as an effort to restrict abortions.

"The law at issue is among the first signs that anti-choice legislatures are beginning to take cues from last year's U.S. Supreme Court ruling upholding the Partial-Birth Abortion Ban Act of 2003," the group said. "Should this law be upheld, it could encourage copycat legislation around the country."

- Brenda Sandburg ([email protected])