Legislation will Suspend FDA’s Approval of RU-486; Review FDA’s Approval Process for Drug

(WASHINGTON, D.C.) – U.S. Representatives Jim DeMint (R-S.C.), Roscoe Bartlett (R-MD) and Senator Sam Brownback (R-KS) today introduced “Holly’s Law” — technically known as the “RU-486 Suspension and Review Act of 2003.” The legislation was introduced with 59 original cosponsors in the House, including Majority Leader Tom DeLay (R-TX). Senator Brownback is introducing a companion bill in the Senate.

Monty and Helen Patterson, the parents of 18-year-old Holly Patterson who recently died after taking RU-486, offered a letter of support for the bill. Representatives Joe Pitts (R-PA), the chairman of the House Values Action Team, Chris Smith (R-NJ), head of the House Pro-Life Caucus and representatives from Concerned Women for America, the Christian Coalition, Family Research Council, and Eagle Forum offered comments in support of the bill.

“What makes Holly Patterson’s untimely death even more tragic is that it was preventable,” DeMint said. “When the Clinton administration rushed approval of RU-486 in its waning days in 2000, many Members of Congress knew that the FDA cut corners and compromised safety. We should not have to wait for another death before Congress suspends FDA’s approval of RU-486 and conducts an independent review of the irregular procedures the FDA used to push this drug onto the market.”

One irregular aspect of the FDA’s approval process for RU-486, DeMint said, was the FDA’s decision to approve RU-486 under a protocol reserved for drugs intended to treat life-threatening illnesses.

“Defining pregnancy as a life-threatening illness was a thoroughly political, not scientific, decision. Any reasonable person committed to protecting the health and safety of women should conclude that the approval process for RU-486 deserves an independent review,” said DeMint, noting that when Baltimore Orioles reliever Steve Bechler died after taking the supplement ephedra, Congress held hearings and government officials praised athletic organizations for banning the substance.

At least three other women have died from RU-486 in North America and at least 13 have required blood transfusions due to excessive blood loss. In 5-8 percent of cases, RU-486 causes severe complications. Danco, the drug’s manufacturer, has reported at least 400 adverse events since RU-486 was approved.

“If airplanes were as dangerous as RU-486 no reasonable woman would ever fly. This deadly drug needs to be grounded immediately and safety procedures need to be reviewed before more women are put at risk,” DeMint said, observing that a woman is 200 times more likely to be injured or killed from RU-486 than in an airplane crash. “People on both sides of the abortion debate should not be distracted from the fact that the health and safety of American
women is being compromised by RU-486 safety guidelines that are more lenient than in France.”

In France, there is a required week of reflection after the initial diagnostic visit. At the next visit, the pills are taken and the patient is scheduled to return in 48 hours, at which time she receives a small amount of prostaglandin. A final visit is recommended to verify the completeness of the procedure. In the U.S., the FDA requires that women be counseled about the procedure, sign informed consent forms and be provided with telephone numbers of medical
personnel in the event of complications.

“As the parents of Holly Patterson wrote so eloquently, we need to end ‘the conspiracy of silence’ surrounding this drug. Too often, supporters of RU-486 have sacrificed the health and safety of women to achieve greater access to abortion,” DeMint said.

DeMint added, “Monty and Helen Patterson wrote in an open letter to the media, ‘We have lost our daughter, Holly, but we can still help to prevent this terrible tragedy from happening in other families.’ It’s time for Congress to act before more women needlessly
suffer in silence.”