FDA pulled from both sides on abortion pill

Advocates on both sides of the abortion-rights issue are skeptical of the Food and Drug Administration’s ability to follow up on the conclusion by government scientists that the abortion pill known as RU-486 is generally safe despite at least five fatalities.

The Food and Drug Administration (FDA) is facing the prospect of continued calls from members of Congress and allied organizations that oppose abortion rights to withdraw the drug because of lingering safety concerns. But any actions taken by the agency to restrict access to the drug would amplify charges that senior officials in the Bush administration are interfering with the FDA for political reasons.

The abortion drug, also called mifepristone and Mifeprex, has been a thorn in the side of the FDA since before it was approved in 2000 during the waning months of the Clinton administration. The pill is manufactured by Danco Laboratories.

Most recently, the FDA announced that four California women died from blood infections after inducing abortions using the pill along with another drug called misoprostol.

A report written by scientists from the Centers for Disease Control and Prevention (CDC) confirms that the drugs were responsible for the fatalities but stops short of saying the medicine is generally not safe. The findings were published in the New England Journal of Medicine on Dec. 1.

The two agencies will continue to monitor reports of serious side effects linked to mifepristone

Anti-abortion-rights groups fought to prevent the drug from coming to market and have continually advocated its removal. The news that it had been linked to deadly side effects invigorated those calls this summer.

But Carrie Gordon Earll, a senior analyst for bioethics with Focus on the Family, expressed doubt that the FDA would act on their concerns or the evidence of the side effects.

The fact that the drug remains available “does make you wonder if they are taking this as seriously as they would if it were another substance,” Earll said. Other drugs with safety profiles she described as similar have been banned, she added.

Earll said that she believed that the career staff at the agency was predisposed in favor of abortion rights and that advocates for abortion rights held sway over FDA decisionmaking.

Pro-abortion-rights advocates regularly contend that the FDA is politically biased in opposition to abortion rights.

Given that the FDA has not endorsed the CDC’s conclusions and that the agency will continue to weigh new restrictions, Ted Miller, a NARAL Pro-Choice America spokesman, asked, “Is the Bush administration doing this for political or scientific reasons?”

A spokesperson for the Department of Health and Human Services insisted that agency policy is based on scientific conclusions.

“We’ll go where the science takes us … as we would in the case of any drug.” Calls to the FDA were not returned.

The drugs agency also has been subject to widespread criticism about its oversight of prescription drugs. The much-publicized removal of Merck’s popular painkiller Vioxx from the market gave FDA critics ammunition to say the  agency was failing to protect the public from unsafe medicines.

The agency also has yet to rule on another drug that has attracted the intense interest of abortion activists. The failure of the FDA to render a decision on whether Plan B, an emergency contraceptive pill, can be sold without a prescription has cast doubt on the agency’s resolve to act on controversial medicines.

After reporting the mifepristone-related deaths, the FDA tasked the CDC to investigate the deaths to determine whether the drug poses a major safety risk for a large number of people. Though there have been at least five deaths, including one due to an ectopic pregnancy that resulted when the drug failed, about 460,000 prescriptions for mifepristone have been filled since 2000. One Canadian woman also died from a blood infection.

“Available data suggest that the risk of [blood] infection is low,” the CDC report says. The article also notes that combining mifepristone with mifepristol was not specifically approved by the FDA. Local and state officials in California also contributed to the report.

The CDC’s findings do not provide a clear guidance for the FDA to follow. The article also is accompanied by a disclaimer reading, “The views expressed are those of the authors and do not necessarily represent the views of the Department of Health and Human Services.”

Marc Fischer, the CDC epidemiologist who is the lead author of the study, emphasized that the agency was not seeking to recommend regulatory actions to the FDA. “Our purpose was just to make this information available to people.”

In addition to helping doctors and patients decide whether they want to use the pill, the article should prompt physicians to report serious side effects to the FDA and the CDC, he added.