FDA Ruling on Abortion Drug Looms; Pro-Lifers Brace for Bad News

July 7, 2008 - 8:02 PM

(CNSNews.com) - The abortion drug RU 486, used by women in Europe and China over the last decade to end early-term pregnancies, may win marketing approval for the first time in the United States later this month.

Pro-life organizations plan to continue pointing out what they see as the dangers of the drug, to convince the Food and Drug Administration to maintain its ban on RU-486, but at least one pro-life group expects to lose the battle.

"We are making plans on the assumption that the FDA will grant approval," Laura Echevarria, a spokeswoman for the National Right to Life Committee said. Echevarria added that her organization is still considering how it might react to FDA approval of RU-486, which is meant to be used with a second drug that causes contractions.

Long active in the effort to prevent RU 486 from entering the U.S. market, the National Right to Life Committee previously published a lengthy review of the drug that described in detail a variety of physical and psychological dangers associated with the drug. Echevarria said the committee was alarmed by the fact that one to two percent of women in Europe and in the U.S. clinical trials required hospitalization due to hemorrhaging.

The American Life League is also urging Americans to contact the FDA and argue for the rejection of the drug on safety grounds. "This is a very dangerous drug," said Jim Sedlak, Director of Public Policy for the group. "There should be a whole host of [safeguards] in place before FDA approves it."

The American patent holder for the drug, the Population Council, a public interest group based in New York City, is working with a start-up drug company, Danco Laboratories, to get FDA approval in the U.S.

According to a Wall Street Journal report this week, Danco Laboratories has major financial backing from, among others, billionaire businessmen Warren Buffett and George Soros.

By the end of September, the FDA will either approve RU 486, reject it or raise more questions and concerns that Danco will need to address. Previous safety concerns, posed by the FDA, have reportedly been addressed by the Population Council and Danco Labs.

The FDA regulates and approves new drugs before they reach American consumers, a process which takes an average of a year from the time a company applies for the right to sell a drug.

However, the FDA reviews only a drug's "safety and efficacy" for consumers, and makes no judgment about its political implications.

"RU 486 has to go through the same type of review process as other drugs," according to an FDA spokesperson. Under the standard criteria, the only hurdles for Danco and the Population Council will be to pass clinical trials and other safety tests, the spokesperson said.

Pro-life groups and legislators seemed somewhat surprised by the news that an FDA decision was forthcoming on RU-486, perhaps in part because the FDA does not usually reveal or confirm its timetable for approving a drug.

U.S. Rep. Tom Coburn (R-OK), who has tried and failed to block funding for the FDA's assessment of RU 486, is drafting a letter to the FDA, raising consumer safety concerns.

The second drug in the two-step process is of particular concern to Coburn. "It has caused exploding uteruses when [doctors] have used the drug to induce labor," said John Hart, Press Secretary to Coburn.

The Population Council claims RU 486 is a relatively safe drug. Christine Horzepa, a spokeswoman for the Council, points to its wide use in Europe over the last decade.

"There's been only one death of a woman in France, years ago," Horzepa said. Otherwise, "the drug's side effects [and complications] are the same as miscarriages that occur naturally," she said. Some side effects of the drug include hemorrhaging, nausea, diarrhea, vomiting and painful cramping.

In 1998, the Population Council received $3.6 million from the federal government for its domestic and international programs to distribute contraceptives.