WASHINGTON WATCH
Congress delves into science with RU-486
By Lisa Kaeser, JD
Senior Public Policy Associate
Alan Guttmacher Institute
Washington, DC
A high-profile amendment that would have banned final U.S. Food and Drug Admin istration (FDA) approval of a drug that causes early abortion, mifepristone, better known as RU-486, nearly made it into law this year. It was dropped at the last minute. If the amendment had been adopted, it would have represented the deepest congressional incursion into the FDA approval process on a specific drug to date.
In June, Rep. Tom Coburn (R-OK) offered an amendment to the fiscal year 1999 agriculture appropriations legislation (which funds the FDA, among other agencies), stating, "None of the funds in this act may be used by the Food and Drug Administration for the testing, development, or approval (including approval of, production, manufacturing, or distribution) of any drug for the chemical inducement of abortion." In his statement on the House floor, Rep. Coburn made his intent clear: to stop all further agency actions toward final approval of RU-486.
The saga of RU-486 has stretched on for more than a decade. It was introduced in France and is approved in two other countries, with others reportedly soon to follow. Discouraged by the U.S. political scene, the drug’s original manufacturer gave the U.S. distribution rights to the nonprofit Population Council of New York City, which spearheaded the clinical trials in this country.
In 1996, the FDA issued an "approvable" letter, meaning that it had determined that the drug was safe and effective for the termination of early pregnancy. However, additional data on manufacturing practices and proposed labeling is necessary for final approval. While various obstacles — including the identification of a manufacturer — have delayed the process, the Coburn amendment would have stopped the process in its tracks.
Issue divides Congress
This year, Congress has been beset by reproductive health-related issues, largely at the behest of a small group of conservative members who have made them a top priority. In particular, the vote on so-called "partial birth" abortion was a difficult one for many members, especially in an election year when votes on social issues are closely scrutinized.
When the Coburn amendment was offered, anti-abortion members presented it as "another" abortion issue and stated they did not want their taxpayer dollars to fund abortion drugs.
Numerous medical, health, and research groups weighed in with three major arguments against the amendment:
• First, although abortions late in pregnancy are more difficult for many people to accept, RU-486 is an advance in that its use is in the earliest stages of a pregnancy. However, Congress was not dealing head on with the more fundamental question of whether abortion should be legal.
• Second, many groups questioned the propriety of Congress imposing its scientific judgment on the FDA.
• Third, the future implications of this action could be serious for a wide range of drugs and devices that might have an abortifacient effect but would be approved for other uses. This fight is led by Rep. Rosa DeLauro (D-CT), an ovarian cancer survivor. In a letter signed by 20 members, the amendment was called a "slap in the face of anyone who is fighting to beat cancer and other deadly diseases."
Amendment deleted, for now
Despite this vocal opposition, the House nonetheless approved the Coburn amendment by a vote of 223-202. The Senate, on the other hand, did not include similar language in its version of the agriculture appropriations bill, and it refused to accept the House version.
In the end, distracted by the presidential impeachment inquiry and the need to approve all appropriations measures before adjourning for the year, the Coburn amendment was deleted from the final version of the legislation. Still — particularly given the success in the House — the matter is likely to resurface next year, depending somewhat on shifts made in the makeup of Congress after the November elections.
FDA candidate quizzed
Notably, the agriculture bill was not the only forum for a debate on RU-486; its potential approval nearly submarined the nomination of Jane Henney as FDA commissioner.
A former FDA deputy and cancer researcher, Jane Henney was nominated by President Clinton to succeed David Kessler, a post that has been vacant since February 1997. During her confirmation process, she was grilled on numerous subjects, especially whether she would give final approval to RU-486.
Following her initial hearing by a Senate committee, Henney had to submit a lengthy response to additional questions from the senators. Her answers focused on RU-486’s approval "for its intended use," i.e. abortion, and its safety for a pregnant woman.
Although Henney’s nomination has been approved by the committee and forwarded to the full Senate, the Senate did not take it up before leaving for the year. Consequently, it is highly likely that the RU-486 issue will crop up again early next year. Meanwhile, the FDA post will go unfilled.
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