In President Bush’s recent State of the Union Address he said, “A hopeful society has institutions of science and medicine that do not cut ethical corners, and that recognize the matchless value of every life.” The next day Republican Rep. Roscoe Bartlett from Maryland held a press conference at the Rayburn House Office Building to urge a House vote on Holly’s Law, or H.R. 1079.

Holly’s Law asks Congress to suspend the medical abortion drug RU-486 from the market, a drug that has claimed the lives of eight women, five of whom were American. At least 800 women have experienced adverse affects since it was approved by the FDA in September 2000.

Congressman Bartlett said, “?the FDA slashed ethical and procedural corners when it approved RU-486 under a special ‘restricted distribution’ approval process known as ‘Subpart H,’ reserved only for drugs that treat ‘severe or life-threatening illnesses.’”

Approved in France in April 1990 as an abortion drug, those supporting Holly’s Law blame the Clinton administration for pressuring the FDA to rush in making RU-486 available in America.

“The Clinton administration rushed RU-486 to approval for political purposes, and as a result numerous safety concerns were suppressed, trivialized and overlooked,” said Rep. Chris Smith (R-N.J.). “RU-486 is not therapeutic, it was developed to kill, which should?by the definition of a drug?be reason enough for the FDA to ban its use.”

On their website Planned Parenthood lauds RU-486, also known as Mifepristone or MifeprexTM, as safe and effective. In their history of the drug’s approval they said, “In spite of its demonstrated effectiveness, safety, and acceptability, mifepristone was continuously targeted by anti-choice activists, causing numerous and lengthy delays in the efforts to make the drug legal and available to the many Americans it might benefit.”

Planned Parenthood said the Bush administration banned the importation of the drug into the U.S. from 1991-92 because of the administration’s anti-abortion stance. But could it have been because there was a lack of standard FDA clinical trials and that the drug was unsafe?

In a report from The Annals of Pharmacotherapy in January 2004, Dr. Byron C. Calhoun, and Dr. Donna J. Harrison said, “The normal FDA approval process requires 2 randomized, blinded, controlled trials to answer questions regarding safety and efficacy of the drug. The use of randomized controlled trials is required by the FDA in its own administrative laws as the basis for the drug approval process?However, data submitted to the FDA from the U.S., as well as data from France, leading to the approval of mifepristone were not gathered from controlled, randomized, or blinded trials?In addition, an FDA investigation of the French data raised concerns about falsification.”

In another report in The Annals of Pharmacotherapy, February 2006, by Dr. Harrison and Dr. Margaret M. Gary reported that since September 2000, 857 women have experienced adverse events from RU-486, 64 were life-threatening, 168 experienced severe hemorrhages and seven required serious emergency surgery. And let’s not forget the eight fatalities from RU-486, plus the obvious fact that not all complications associated with an abortion are reported.

“There is independent statistical evidence that these [RU-486] usage figures may be inflated,” said Dr. Randall O’Bannon, Educational Director for National Right to Life Committee (NRLC). “There is also reason to believe that deaths and other adverse events are seriously undercounted. How many women never tell their families they’ve taken the abortion pill? How many are not even able to tell the doctor in the E.R.? The system waits for prescribers to call and report adverse events to the distributor, but a clinic may never see or hear from a woman again once she leaves their door.”

One such woman was 18-year-old Holly Patterson from Livermore, California. She visited a local Planned Parenthood clinic on September 10, 2003, and based on her Internet research decided on a medical abortion using RU-486. In severe pain Holly went to the ER on September 14. She admitted she had taken an abortion pill but was sent home with pain medication after a pelvic exam. The National Right to Life website reported that three days later on September 17, 2003 Holly died from a “massive reproductive tract infection.”

“Holly’s Law is a very modest bill,” said Deirdre A. McQuade the Secretariat for Pro-Life Activities, United States Conference of Catholic Bishops. “It provides only for temporary suspension of the Food and Drug Administration’s approval of RU-486 so the Comptroller General can review that agency’s adherence to statutory mandates in its process for approving the drug. If supporters of RU-486 believe the FDA followed the law in approving RU-486 for abortion, they should have nothing to fear from the proposed review.”

At Wednesday’s press conference Rep. Bartlett said he hopes to get Holly’s Law to the House floor during the next session.

The bill was first introduced in November 2003 when it was known that RU-486 had been the cause of four deaths. Hopefully this time something will be done.

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