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Prescription Drug User Fee Amendments Of 2007

Floor Speech

By:
Date:
Location: Washington, DC


PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007 -- (Senate - May 02, 2007)

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Mr. DeMINT. Mr. President, my amendment calls for the Food and Drug Administration to conduct an assessment of the risk evaluation and mitigation strategy, which we refer to as REMS, for Mifeprex, commonly known as RU-486, within 7 months of the effective date of this legislation.

According to the legislation before us, any drug that is currently on the market with restrictions on its distribution or use, which includes RU-486, would be required to have a risk evaluation and mitigation strategy. This means that RU-486 would be subject to periodic assessment of how well the risk management plan, including its restrictions, is working. Unfortunately, the bill does not establish a deadline for the risk evaluation for RU-486.

The current RU-486 abortion regimen was approved by the Food and Drug Administration in September of 2000. Since that time, the regimen has been linked to the deaths of seven women, including three Americans. The public has learned since November of 2004, through the release of documents by the FDA through a Freedom of Information Act request, that over 1,000 additional women have experienced adverse effects from the RU-486 regimen, including 9 life-threatening incidences, 232 hospitalizations, 116 blood transfusions, and 88 cases of infection. It should be noted this dangerous drug is attacking young, healthy women.

I also want to point out the approval process for RU-486 was highly irregular in the first place. The drug regimen was approved under FDA subpart H, which is a regulation that applies to certain new drugs used for treating serious or life-threatening illnesses. While certain conditions may arise during pregnancy that are dangerous, pregnancy itself is hardly a serious or life-threatening illness.

The RU-486 regimen actually requires the use of two drugs: RU-486, which kills the child, and misoprostol, which causes the uterus to expel the dead baby. G.D. Searle, the manufacturer of misoprostol, never sought to have its drug approved by the FDA for abortions. Nevertheless, the FDA, in what appears to be an unprecedented decision, mandated that misoprostol be used for unapproved ``off-label'' use in an abortion regimen along with RU-486.

Finally, the FDA approved the RU-486 regimen based on data submitted from clinical trials in which there was no control group comparison. This directly violates Federal law and appears to be unprecedented as well.

In my opinion, the FDA has not done enough to curb the use of this deadly drug, and for far too long the FDA has put politics ahead of science and ahead of women's health. When the Clinton administration expedited the approval process for RU-486 in the final days of its tenure, many medical professionals expressed serious concerns about the FDA's rush to bring RU-486 to market. Since then, the statistics have proven these concerns to be well-founded.

The legislation we are considering today has everything to do with drug safety. Yet we have a drug on the market that has killed several women and injured many others. My amendment simply sets a 7-month deadline for the FDA to assess the risk evaluation and mitigation strategy for RU-486. Given all the adverse events associated with this drug, this is the least we can do.

This is not an abortion issue, it is a women's health issue. Even those who support abortion agree there are serious problems with this drug. Let me read several quotes from abortion supporters which were part of a New York Times story that ran last year: ``None of these women should be dying; it's shocking,'' said Dr. Peter Bours, an abortion provider in Portland, OR, who is rethinking whether to offer pill-based or medical abortions.

Dr. Warren Hern, an abortion provider in Denver, said the latest reports demonstrated that abortions by RU-486, or Mifeprex, were far riskier than the surgical ones. ``I think surgery should be the procedure of choice,'' Dr. Hern said. ``Pills,'' he said, ``are a lousy way to perform an abortion.''

I quote again from another source: ``The complications associated with RU-486 far exceed the complications of surgical abortion,'' said Dr. Damon Stutes. He is an abortion provider in Reno, NV. He refuses to offer pill-based abortions.

Dr. Stutes, whose clinic has been bombed, said he was uneasy about agreeing with abortion proponents on anything. But the truth is the truth, he said.

Another quote:

One needs to tell patients that the medical procedure, even though it seems more natural, may be more likely to result in death.

That is Dr. Phillip G. Stubblefield, a professor of obstetrics and gynecology at Boston University.

It is clear that even the supporters of abortion believe this drug is dangerous. It also appears that even the leader of the abortion industry--Planned Parenthood--supports actions by the FDA to further examine the safety of the drug. Dr. Vanessa Cullins, vice president for Medical Affairs at Planned Parenthood, told the San Francisco Chronicle:

We are glad there will be continuing investigations by the FDA. We will work with the CDC, the FDA, and academicians to figure this out.

The FDA needs to quickly complete its risk evaluation on RU-486. That is what my amendment guarantees. I urge my colleagues to support it. I understand that Senator Kennedy will accept a voice vote on this. I look forward to supporting it, along with all of my colleagues.

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