The Center for Reproductive Rights (CRR) filed a lawsuit today seeking an injunction against a new North Dakota law that, by placing new and unnecessary restrictions on the safe and common use of FDA-approved drugs to induce first-trimester abortions, would effectively ban medication abortions entirely.

According to CRR:

The suit alleges that North Dakota House Bill 1297, passed in 2011, is incomprehensible and completely misconstrues the role of the federal Food and Drug Administration in approving drugs for the market.

The law is scheduled to take effect on August 1.

As is the case with an Ohio law about which I wrote in June, the North Dakota law ignores the medical and scientific evidence regarding safety of medication abortion and creates a different standard for clinical delivery of an abortion drug than for other drugs approved by the U.S. Food and Drug Administration (FDA).  In fact, both the intent of the North Dakota law and its implications are virtually identical to the Ohio law.

Off-label use of drugs already approved by the FDA is commonplace in the medical community, based on research and data collected on uses other than the original use of a drug that has otherwise been deemed safe.  A 2009 study found that 62 percent of pediatric office visits included off-label prescription practices. A 1997 study of cancer doctors by the American Enterprise Institute and the American Cancer Society found that 60 percent of the doctors prescribed drugs off-label, and a 1991 study by the United States General Accounting Office found that more than half of cancer patients were prescribed at least one drug off-label.  And the Archive of Internal Medicine says such off-label uses account for 21 percent of all prescriptions.

CRR advocates say the state is taking away an option widely recognized as safe and effective by the World Health Organization, the American College of Obstetricians and Gynecologists, and other medical experts and professional organizations—and needlessly forcing all women seeking abortions to undergo a surgical abortion procedure even when such a procedure may be medically inadvisable.

“North Dakota has enacted a law that defies reason, science, and the expertise of doctors worldwide in an underhanded effort to deny women their legal right to terminate a pregnancy safely, early, and in accordance with their doctors’ advice and their own wishes,” said Nancy Northup, president and CEO of the Center for Reproductive Rights.

“It is unimaginable that any other medical procedures would be targeted for restrictions aimed at reducing their effectiveness and increasing their expense and inconvenience. This is an assault on women’s reproductive rights and health, pure and simple.”

While the law as written aims to restrict the two drugs used in medication abortion procedures to their uses as tested and authorized by the FDA, the FDA takes no such role in drug testing and imposes no such limits itself.  

And, notes CRR, while the protocol used by the North Dakota health care providers to perform medication abortions is in accordance with the best available medical evidence, the law attempts to restrict medication abortions strictly to the regimen on the FDA-approved drug labels.  The FDA itself acknowledges that its approval of a drug label for marketing purposes is not intended to restrict alternative “off-label” use—and that good medicine often requires such use.

“No other provision of North Dakota law denies access to off-label prescriptions, and there are, in fact, provisions that actually seek to protect off-label uses of other medications,” said Suzanne Novak, senior staff attorney for the Center for Reproductive Rights and lead counsel on the case. “Doctors around the world and the FDA itself recognize that off-label prescription is responsible for important advances in medical care. It is precisely these advances that the state is trying to deny North Dakota women.”  

After initial successes, Planned Parenthood lost a suit seeking an injunction against the Ohio law in June.  That law also continues to be challenged.