WASHINGTON – Opponents of the abortion-inducing pill Mifeprex said Congress should ban the medication because it led to nine deaths among women who took it.
A subcommittee of the House Government Reform Committee heard from opponents and supporters of the pill,also known as RU-486 or mifepristone,at a hearing Wednesday.
Mifeprex,a prescription drug approved by the Food and Drug Administration,allows a woman to stop a pregnancy within 49 days of conception. However,this drug is also thought to be a cause of Clostridium sordellii infections that can be deadly.
According to the Centers for Disease Control and Prevention,this bacterium can cause a woman to experience nausea,vomiting,diarrhea and abdominal pain.
Although considered a rare complication,nine women are known to have been infected and died weeks after taking Mifeprex. But witnesses also said that women are known to have died from the same infection after giving birth.
“The FDA is responsible for protecting public health and therefore,must reconsider the use of RU-486 in the early medical pregnancy termination” said Monty L. Patterson,father of 18-year-old Holly Patterson,who died after taking Mifeprex.
“It is my vibrant memory of Holly and her premature death that have inspired me to make the public aware of the serious and lethal effects of RU-486,” Patterson said.
The FDA was accused of rushing the drug to market under the provision of regulation Subpart H,under which the FDA can speed up approval of certain drugs.
O. Carter Snead,associate professor of law at the University of Notre Dame,said, “Subpart H was designed in part as an alternative means of approval for useful drugs that would otherwise fail the traditional risk/benefit calculus required for FDA approval.”
However Dr. Janet Woodcock,FDA deputy commissioner for operations,said that “under Subpart H,a drug product shown to be effective can be used safely only if distribution or use is restricted. The Agency will require post-marketing restrictions.”
Dr. Lisa D. Rarick,of RAR Consulting,told the subcommittee that the FDA had taken all of the measures possible to ensure the safety of the pill. She said that subpart H approval allows for more oversight of promotional materials but does not accelerate approval.
“The approval of mifepristone in September 2000 was based on more than the necessary number of studies submitted and reviewed by the division of which I was director,” Rarick said.
Rarick held several positions at the FDA before leaving to become a consultant for drug companies and reproductive health issues.
Rarick also argued there are lots of drugs on the market that have dangerous side effects. “Viagra killed thousands of people,but it's still on the market” she said.
The committee members were split on what to do,but said they wanted the issue to remain scientific and not political.
“RU-486 is an issue based on science and law,not politics” Rep. Henry A. Waxman,D-Calif.,said. Rep Diane Watson,D-Calif.,said it is important for Congress to treat the issue with unbiased integrity.
Waxman traded jabs with one witness,Dr. Donna Harrison,a member of the Mifeprex Subcommittee of the American Association of Prolife Obstetricians and Gynecologists. Waxman accused Harrison of being against the drug because the group she represents is against abortion.
Although the goal was to remain objective and scientific,the topic of abortion seemed almost avoidable.
“I think we should all find out everyone's opinion on abortion” said Rep. Jean Schmidt,R-Ohio.
Rep. Mark Souder,R-Ind.,the subcommittee chairman,said he hopes to have the abortion pill pulled off the market. The committee may hold another hearing before taking any action,he said.