Law Banning Off-Label Use Of Abortion-Inducing Drugs Struck Down In Oklahoma

by Lakshmi Darshini on  August 11, 2015 at 6:05 PM Drug News
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An Oklahoma law that required doctors to follow label instructions when prescribing abortion-inducing drugs was struck down by a judge on August 10, saying the rule is unconstitutional because it does not apply to other kinds of medication.
Law Banning Off-Label Use Of Abortion-Inducing Drugs Struck Down In Oklahoma
Law Banning Off-Label Use Of Abortion-Inducing Drugs Struck Down In Oklahoma

This law was invalidated by District Judge Patricia Parrish, which the Republican-controlled Legislature approved and Gov. Mary Fallin signed last year. The law prohibited uses of off-label abortion-inducing drugs by requiring the doctors to administer them only in accordance with the U.S. Food and Drug Administration protocols. "Off-label" means the medication is being used in a manner not specified in the FDA's approved packaging label.

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The law placed unconstitutional restrictions on non-surgical abortion in the earliest weeks of pregnancy and interfered with doctors' discretion, argued a lawsuit. Opponents contend lower dosages can make the abortion-inducing drugs more effective later in a pregnancy.

On behalf of Reproductive Services, a nonprofit reproductive health care facility in Tulsa, and the Oklahoma Coalition for Reproductive Justice, the New York-based Center for Reproductive Rights filed the lawsuit.

The law unconstitutionally segregated the abortion-inducing drugs for special restrictions and improperly delegated legislative authority to the FDA, argued Autumn Katz, senior staff attorney for the New York-based abortion-rights group. The law interfered with a doctors' discretion to treat their patients, said Katz.

Restricting the off-label use of the drugs did not serve a valid state interest and about 2 million women have taken the drugs to induce abortions early in their pregnancies, said Katz.

But the Legislature was concerned about the health and safety of women when it adopted the statute, argued Deputy Solicitor General Mithun Mansinghani. At least six women have died in the U.S. after being administered the drugs, justifying the state's law requiring adherence to the FDA protocol, he said. "This particular method has safer alternatives," said Mansinghani.

According to the nonprofit Guttmacher Institute, which advocates sexual and reproductive health and rights, Oklahoma is among the 6 states, along with Arizona, Arkansas, North Dakota, Ohio and Texas, that has passed laws to restrict medical abortions by limiting or banning off-label uses of drugs. Enforcement of the laws in Oklahoma and Arizona had been temporarily blocked pending the outcome of legal challenges.

Among the drugs covered by the laws is mifepristone, originally known as RU-486. The FDA approved its use in 2000 through the first seven weeks of pregnancy. It is prescribed along with a second drug, misoprostol.

But medical researchers and clinical trials have shown that mifepristone is effective in much smaller doses and for two weeks longer in a pregnancy, since its FDA approval. Oklahoma law forced physicians to treat women seeking medical abortions according to an outdated method that is less safe, less effective and more expensive than the method doctors currently use, argued Katz.

Parrish said she was bound by a decision handed down by the Oklahoma Supreme Court in 2012, in striking down the law. That decision upheld a lower court ruling that invalidated a law passed in 2011 that effectively banned all drug-induced abortions in the state.

The office will appeal the decision, said Aaron Cooper, a spokesman for Attorney General Scott Pruitt's office. "As the attorney general has maintained throughout the course of litigation, the Legislature was within its constitutional authority to take steps to prevent off-label uses of abortion drugs in order to protect the health and safety of Oklahoma women," said Cooper.

Source: Medindia

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