By Jeffrey Young - 07/21/05 12:00 AM EDT
The Food and Drug Administration (FDA) decision this week to investigate fatalities linked to the abortion pill commonly known as RU-486 has reignited the contentious political debate surrounding FDA approval of the drug in 2000.
House sponsors of legislation to pull RU-486, also known as mifepristone and Mifeprex, off the market view the FDA’s move as an opportunity to renew the push to move their bill through Congress.
The FDA announced Monday night that four deaths caused by blood infections (or sepsis) have been associated with the drug. Another death was traced to complications from an ectopic pregnancy (when the fertilized egg implants outside the uterus, such as in a fallopian tube) that occurred after the use of mifepristone.
Social conservatives fought hard against the drug’s approval. Many maintained — and continue to maintain — that the Clinton administration rushed the application in an effort to please the pro-choice community without adequately considering safety concerns.
“Bill Clinton should take responsibility” for hurrying the drug to the market, said Rep. Chris Smith (R-N.J.), who chairs the House Pro-Life Task Force. “This was the most politicized acceptance of a [drug] substance in my 25 years [in Congress] and probably before,” Smith said.
“Not only is RU-486 ‘baby pesticide’ … it is poison to the women themselves,” Smith said.
Groups that support abortion rights roundly disagree with the characterization of the drug as dangerous.
“Medication abortion is extremely safe and effective,” said Karen Pearl, interim president of the Planned Parenthood Federation of America. “More than a million women worldwide have used medication abortion safely. Since its approval, women and doctors nationwide report high levels of success and satisfaction with this early abortion option,” Pearl said in a written statement issued yesterday.
Legislation that would block the abortion pill has been circulating in Congress since before the drug was approved, including a measure sponsored by Rep. Roscoe Bartlett (R-Md.) and Sen. Jim DeMint (R-S.C.) that was introduced in March. Bartlett calls the bill “Holly’s Law,” after a woman who died after using the drug in 2003.
Bartlett distributed a “Dear Colleague” letter yesterday that says, “Once again, the urgency of passing [the bill] has been reiterated to the American people.” The bill would remove mifepristone from the market and set in motion an investigation into whether the FDA acted properly when it approved the drug.
The determination that additional deaths have been connected to mifepristone “needs to be the catalyst for action,” Smith said.
House Energy and Commerce Committee Chairman Joe Barton (R-Texas) has not scheduled a hearing on the bill, but a Bartlett aide suggested that support in the House was mounting. The measure now has 69 co-sponsors.
Smith said that members of Congress and outside groups have requested that the FDA reconsider the drug’s application. “I think they have a moral obligation” to review the data, he said.
The FDA, however, did not indicate in its Monday advisory that it plans to take any actions other than monitoring the drug. The agency also emphasized that the deaths resulted from the drug’s being incorrectly used.
A Planned Parenthood spokeswoman said that interference from Congress would impede the FDA’s ability to monitor the safety of mifepristone without bias. “We want the FDA to be able to do its job,” she said.
The drug’s manufacturer, New York-based Danco Laboratories, said there is no established “causal relationship” between the fatal infections and the “medical abortion” induced by its product. Strong warnings about the risk of blood infections were added to the drug’s label last November. Danco, a component of the Population Council, yesterday issued new materials to doctors offices explaining the findings.
The FDA is cooperating with the Centers for Disease Control and Prevention, state and local health departments, and Danco to track and identify any other cases of blood infections or other serious and deadly side effects that may be connected to RU-486.