Congressmen support FDA protocol for abortion pill

Washington D.C., Jan 18, 2012 / 09:47 am

Nearly 20 members of Congress voiced their support for an Ohio law regulating the use of the abortion drug RU-486 in compliance with U.S. Food and Drug Administration protocol.

The legislators backed the law in a brief filed in the Sixth Circuit Court of Appeals, which would prohibit abortion providers from encouraging women to use RU-486 in “off-label” ways that have not been approved by the FDA.

“Eight women in the U.S. have died from bacterial infection following the misuse of RU-486 – a misuse advocated by Planned Parenthood,” said Dr. Charmaine Yoest, president of Americans United for Life, in a Jan. 10 statement.

“Ohio’s law is simply a medical regulation aimed at promoting the safest use of a drug, as it was approved to be used by the FDA,” she added.

Americans United for Life filed the brief on behalf of Speaker of the House John Boehner (R-OH) and U.S. senator Tom Coburn, M.D. (R-OK), along with nine other U.S. representatives from Ohio and seven other representatives with medical backgrounds from around the country.

The brief was filed in a federal case involving an Ohio regulation requiring RU-486 – also known as mifepristone or Mifeprex – to be administered according to FDA recommendations.

Planned Parenthood has challenged the constitutionality of the law, arguing that it is too vague, violates women’s bodily integrity and places an “undue burden” on their “right” to abortion.

But according to the brief, medical regulations are necessary to “protect women from the dangerous off-label use” of RU-486, a drug regimen that – according to the FDA – has killed 14 women and injured more than 2,000 others.

Lower courts have upheld the law, which does not ban the drug, but simply requires that it “be administered in the way deemed safest by the FDA.”

According to the brief, Planned Parenthood has acknowledged that “abortion providers routinely administer RU-486 in a number of ways that fall outside the safety guidelines” established by the food and drug administration.

Such “off-label uses” include administering the drug after the seventh week of pregnancy; failing to examine women before and after taking the drug; and administering the regimen’s second drug – misoprostol – vaginally rather than orally.

The brief said that precedent indicates that “states are given wide discretion to legislate in areas where there is medical and scientific uncertainty.”

Even when used properly, the RU-486 drug regimen is dangerous, it argued. The drug label notes that nearly all women who take it “will report adverse reactions.”

A 2011 report issued by the FDA recorded 2,207 complications in the U.S. related to the use of RU-486, including 14 deaths, 339 blood transfusions, 612 hospitalizations and 256 infections.

Such a risky drug should be carefully regulated in order to “protect the health and welfare of women,” said the brief.

It argued that “potentially 10 out of the 14 reported U.S. deaths could possibly have been prevented” if the mifepristone had been properly administered according to FDA protocol.

The court of appeals will decide the fate of the Ohio bill, which has been tested in a series of courts since its 2004 approval by state legislature.

Yoest explained that the law is important because “women’s lives hang in the balance.”

“Requiring the proper distribution of drugs should be an area of bipartisan agreement,” she said.