Senators Call For Immediate Suspension of RU-486
FDA Reports 2 New RU-486 Deaths
Today, U.S. Senators Jim DeMint (R-S.C.) and Tom Coburn, M.D. (R-Okla.) called on Congress to pass S. 511, the RU-486 Suspension and Review Act, upon learning that two more American mothers have died after taking the deadly abortion pill known as RU-486. There are now seven known deaths due to infection caused by this drug.
"If the FDA is going to continue on its path of inaction, Congress needs to wake up and force it to pull this drug before more women die," said Senator DeMint. "The information about these two new deaths clearly indicates a serious risk to women's health."
"It is unconscionable that the previous deaths connected to RU-486 did not prompt the FDA to immediately suspend and review its approval of this drug," said Dr. Coburn who, as a member of the House of Representatives, opposed the FDA's fast-track approval of RU-486. "Perhaps these latest deaths will finally convince the FDA to put science and women's health ahead of politics. When the Clinton administration rushed RU-486 to the market in the waning days of its tenure, many medical professions expressed alarm about the FDA's corner-cutting and lax safety standards for RU-486. Tragically, those concerns have been proven to be well-founded."
The FDA, in conjunction with the Centers for Disease Control and Prevention (CDC) and the National Institute of Allergy and Infectious Diseases (NIAID), repeated it's intention to conduct a public workshop on May 11, 2006. The goal of the workshop is to bring together scientific and public health experts to develop a draft research agenda leading to a better understanding of the drug and the recent deaths.
Senator DeMint responded by saying, "A workshop to talk about ways to study this problem will only delay action. It is simply not enough. Congress needs to act to take this deadly drug off the market first, and then study the drug second. The FDA skipped several important steps in its approval and now women are dying."
According to the Health Advisory released by the U.S. Department of Health and Human Services today, there are have been seven deaths since 2000 following medical abortion with RU-486. At least 600 additional woman have experienced adverse events from RU-486 including 200 that were either life-threatening or extremely serious. RU-486 was originally approved by the Clinton Administration in September of 2000 under a special "restricted distribution" approval process reserved only for drugs that treat "severe or life-threatening illnesses," like cancer and AIDS.
Last year, Senator DeMint introduced the "RU-486 Suspension and Review Act," which now has 11 cosponsors in the Senate and 79 in the House. The bill is commonly known as "Holly's Law," named after 18-year-old Holly Patterson who died in 2003 from an RU-486 drug-induced abortion. According to the coroner's report, Holly Patterson died within a week as a result of taking the drug. Senator DeMint's legislation would suspend RU-486 from the market until the Government Accountability Office (GAO) conducts an independent review of the FDA's approval process, which was used to declare the drug "safe and effective."
"RU-486 is a deadly drug that is killing pregnant women," said DeMint. "This drug should never have been approved, and it must be suspended immediately."