(PRESS RELEASE) A North Dakota law that introduces new and unnecessary restrictions on the safe and common use of FDA-approved drugs to induce first-trimester abortions would, in fact, ban medication abortions entirely, according to a lawsuit filed today by the Center for Reproductive Rights seeking to block the law from taking effect as scheduled on August 1.
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.”
The Center for Reproductive Rights has been joined by the law firms Weil, Gotshal &, Manges LLP and Turman &, Lang Ltd. in bringing the lawsuit on behalf of the only reproductive health care clinic providing abortion services in North Dakota and the clinic’s medical director.
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.
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 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.
According to the American Cancer Society, most oncologists prescribe off-label uses of various drugs to treat their patients, and the Archive of Internal Medicine says such off-label uses account for 21 percent of all prescriptions.
“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.”