ACLU Interested Persons Memo Regarding S. 511/H.R. 1079, “RU-486 Suspension and Review Act of 2005”

TO: Interested Persons

FROM: ACLU Washington Legislative Office

RE: S. 511/H.R. 1079, “RU-486 Suspension and Review Act of 2005”

_____________________________________________________________________________

The American Civil Liberties Union opposes S. 511/H.R. 1079, the “RU-486 Suspension and Review Act of 2005,” which would withdraw the government’s approval of mifepristone and remove it from the market for at least 180 days while the Government Accountability Office (GAO) “reviews” mifepristone’s long since completed approval process. This bill substitutes Congress’s political whims for the views of scientific experts at the Food and Drug Administration (FDA) and is contrary to the vast weight of medical evidence regarding the safety of this drug.

In September 2000, after more than a decade of careful study, the FDA approved mifepristone (sometimes known as RU-486) as a safe and effective early option abortion pill. Mifepristone’s approval represented a significant breakthrough in reproductive health care for American women, allowing them access to a safe, private, and early option for ending a pregnancy. Indeed, since FDA approval, more than 575,000 American women have safely and effectively used the drug.[1]

Despite mifepristone’s proven safety record, some in Congress are now attempting to circumvent the FDA’s stringent drug approval process to deny women access to this safe abortion method. This bill infringes on a woman’s right to choose the abortion method that is most appropriate for her personal health needs and inappropriately targets a drug proven to be safe and effective. Congress should not substitute its political views for the science-based decisions of the FDA’s medical experts.

Mifepristone is Safe and Effective.

More than one million women worldwide have safely and effectively used mifepristone to end unwanted pregnancies. For example, in addition to women in the United States, more than 600,000 women in Europe safely used the drug between 1989 and 1999.[2]

Mifepristone has continually been proven safe and effective. Prior to FDA approval, U.S. clinical trials involving over 2,100 women demonstrated that mifepristone was effective in terminating 92% of pregnancies up to 49 days from the woman’s last menstrual period.[3] Less than one percent of all participating patients were hospitalized after taking the drug.[4] Similarly, mifepristone has been proven to be extremely safe in the period since its approval in 2000. Since then, the FDA has received reports of 676 adverse events, including minor symptoms such as nausea and dizziness. That is a reported adverse event rate of 0.19 %, meaning that fewer than 2 out of 1,000 women experienced an adverse event when using mifepristone.[5] To place this in context, in 2003, the FDA Center for Drug Evaluation and Research (CDER) received nearly 371,000 post-marketing adverse event reports overall for all drugs.[6] Indeed, as Janet Woodcock, Director of CDER explains, “no pharmacologically active medicine exists that does not have side effects.”[7] Moreover, the FDA has made clear that even the reported mifepristone adverse events “cannot with certainty be causally attributed to mifepristone because of information gaps about patient health status, clinical management of the patient, concurrent drug use and other possible medical or surgical treatments.” [8]

Finally, the risk of death from mifepristone use is – like the risk of death from legal abortion in general – extremely low (below 1 per 100,000),[9] and, indeed, much lower than the risk of death associated with childbirth. While the estimated fatality rate associated with mifepristone use is 0.8 deaths per 100,000 procedures, the pregnancy related mortality rate (defined as a woman’s death that is due to pregnancy and that occurs during or within a year after the end of the pregnancy) is 12.9 deaths per 100,000 live births.[10]

Access to Mifepristone Increases Women’s Access to and Options for Safe Reproductive Health Care.

The availability of medical (non-surgical) abortion using mifepristone is an important health care option for women, and one that women have come to rely on. In 2003, the percentage of U.S. women choosing mifepristone doubled from the first full year of availability in 2001.[11] Though surgical abortion is extremely safe, early medical abortion has significant reproductive health benefits for some women: women are sometimes able to end a pregnancy earlier, do not have to undergo surgery, and do not have to use anesthesia. Moreover, given that 87% of all U.S. counties have no abortion provider,[12] the availability of medical abortion potentially allows women who live prohibitively far from a surgical abortion provider to exercise their right to end a pregnancy. Continued access to this safe, private, and early abortion option is critical to protecting women’s reproductive rights and their access to safe abortion care.

Congress Should Not Second-Guess the Considered Judgments of Medical Experts at the FDA.

The FDA, the expert body charged with ensuring the integrity of the drug-approval process and the safety of drugs used in the United States, approved mifepristone after careful evaluation of medical evidence under strict scientific protocols. It approved the drug only after thoroughly reviewing three full phases of clinical trials involving thousands of women, and issued its approval more than four years after mifepristone’s sponsor first submitted its application.

Contrary to assertions that mifepristone was “fast-tracked” through the FDA approval process, the drug was in fact approved pursuant to FDA regulation “Subpart H,”[13] an expressly stringent approval channel. The approval process for mifepristone spanned 54 months. In contrast, the median total approval time for all other new molecular entities approved that year was 15.6 months.[14] Pursuant to Subpart H, the FDA imposed distribution restrictions not imposed on the vast majority of prescription drugs,[15] and subjected mifepristone to additional study requirements even after its approval.[16] Indeed, the FDA itself has made clear that it employed Subpart H in order to impose these prophylactic restrictions on the distribution of mifepristone.[17]

In short, there is simply no evidence of improprieties or short cuts in the FDA’s approval process for mifepristone. S. 511/H.R. 1079 nevertheless denies women access to this critical drug while Congress launches an unnecessary six-month review. Congress should not substitute its political assertions for the FDA’s considered medical judgments.

Further Restrictions on Mifepristone Are Not Medically Necessary and Would Severely Impede Access to the Drug.

In past years, members of Congress have proposed, but never succeeded in enacting, severe and unwarranted restrictions on mifepristone. Although it is unclear whether members of Congress intend once again to propose such restrictions (either in S. 511/H.R. 1079 or in some other legislative vehicle), these restrictions would be no more appropriate today.

For example, some members of Congress have sought to limit mifepristone prescribers to providers of surgical abortion who have hospital admitting privileges within one hour of their practice and who are certified for ultrasound dating of pregnancy. Such restrictions are medically unnecessary and were already considered and rejected by the FDA.[18] Moreover, the FDA already requires health care providers to meet appropriate qualifications in order to prescribe mifepristone: they must be able to assess the duration of a pregnancy, provide or arrange for surgical intervention if necessary, and assure patient access to emergency medical care.[19]

In addition to being medically unnecessary, these many-layered limits would so restrict the pool of mifepristone providers as to place the drug out of reach for many American women. Needless restrictions thus threaten part of the promise of mifepristone, which was to make early abortion accessible for women who live far from a surgical abortion provider.

S. 511/ H.R. 1079 Raises Serious Legal Concerns.

S. 511/H.R. 1079 would remove mifepristone from the market for at least 180 days while the GAO conducts a “review” of the FDA’s long since completed approval process. There are serious questions about the legality of such an effort.

First, the bill would likely pose an undue burden on a woman’s right to choose medical abortion in the first trimester of pregnancy. As the Supreme Court articulated in Planned Parenthood v. Casey, a state regulation on abortion amounts to an unconstitutional undue burden when it “has the purpose or effect of placing a substantial obstacle in the path of a woman seeking an abortion of a nonviable fetus.” 505 U.S. 833, 877 (1992). S. 511/H.R. 1079 would remove mifepristone from the market, thus making it impossible for women to access a safe, common method of previability abortion. There is no greater “substantial obstacle” to abortion care than an outright ban of an abortion method that will be the safest option for some women in some circumstances. See Planned Parenthood Cincinnati Region v. Taft, 439 F.3d 304, 312-14 (6th Cir. 2006) (recounting expert testimony establishing that for some women medical abortion is a safer option than surgical abortion).

Second, in violation of clear Supreme Court precedent, the bill lacks a life and health exception. The Supreme Court has consistently held that any law restricting access to abortion must contain an exception to protect women’s health and lives. See Casey, 505 U.S. at 846, 879-80; Stenberg v. Carhart, 530 U.S. 914, 931 (2000). For some women, preexisting health conditions make most forms of surgical abortion relatively contraindicated. Because the bill does not contain a health exception, it would preclude this option even for a woman with health concerns faced with the prospect of undergoing a relatively contraindicated surgical abortion procedure. The bill, by failing to provide a life or health exception, is likely constitutionally infirm. See Taft, 439 F.3d at 315 (affirming, in part, grant of preliminary injunction enjoining application of state law prohibiting “off-label” use of mifepristone because the law did not contain a constitutionally required health exception).

Additionally, the bill appears to infringe on a woman’s right to bodily integrity. As the Supreme Court has made clear, the right to choose an abortion “is a rule . . . of personal autonomy and bodily integrity.” Casey, 505 U.S. at 857. Central to this right is a woman’s ability, in consultation with her doctor, to choose the abortion method that is most appropriate for her individual health needs from among all safe and available abortion procedures. A restriction that denies women access to a safe, non-surgical method of abortion abridges this right and is therefore unconstitutional.

Finally, this bill singles out an abortion drug for treatment different from comparable drugs without sufficient basis. The Constitution does not permit Congress to target safe abortion drugs for discriminatory, burdensome restrictions -- and removal from the market -- without justification. This appears to be precisely what this bill does.

For all these reasons, the bill stands on shaky legal ground.

* * * *

Because S. 511/H.R. 1079 would severely restrict women’s access to a safe, effective, and early abortion option, the ACLU strongly opposes its passage.

Endnotes

[1] April 7, 2006, email communication with Danco Laboratories, the manufacturer of Mifeprex (mifepristone); see also FDA Questions and Answers on Mifeprex (Nov. 4, 2005), available at http://www.fda.gov/cder/drug/infopage/mifepristone/mifepristone-qa20050719.htm (460,000 estimated uses of Mifeprex in the United States between September 2000 and June 2005).
[2] Population Council, Mifepristone: A Chronology (January 2001). [3] Center for Drug Evaluation and Research, U.S Food and Drug Administration, Application No. 20-687, Medical Review(s), Part 1, at 7, 11 (1999), http://www.fda.gov/cder/foi/nda/2000/20687_Mifepristone_medr_P1.pdf.
[4] Id. at 13.
[5] Center for Drug Evaluation and Research, U.S. Food and Drug Administration, FDA Mifepristone Questions and Answers (July 19, 2005), available at http://www.fda.gov/cder/drug/infopage/mifepristone/mifepristone-qa20041115.htm (adverse event data current through November 2004).
[6] CDER Report to the Nation: 2003, available at http://www.fda.gov/cder/reports/rtn/2003/rtn2003-3.HTM#AERS.
[7] Statement by Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research, Food and Drug Administration, Before the Subcommittee on Oversight and Investigations, December 11, 2002, available at http://www.fda.gov/ola/2002/accutane1211.html.
[8] Center for Drug Evaluation and Research, U.S. Food and Drug Administration, FDA Mifepristone Questions and Answers (July 19, 2005), available at http://www.fda.gov/cder/drug/infopage/mifepristone/mifepristone-qa20041115.htm.
[9] David Grimes, Risks of Mifepristone Abortion in Context, 71 Contraception 161 (2005).
Five women have died after using mifepristone, but the FDA has not determined whether the drug was linked to the deaths. FDA Mifeprex (mifepristone) Information Update (April 10, 2006), available at http://www.fda.gov/cder/drug/infopage/mifepristone/default.htm . In the four cases in which it has completed its investigation, the FDA determined that the women tested positive for a bacterium called Clostridium sordellii, and died from sepsis (infection). Fatal infection associated with this bacterium occurs outside the abortion context, in such procedures as skin grafts and, importantly, childbirth. FDA Public Health Advisory, Sepsis and Medical Abortion Update (March 17, 2006), available at http://wwwda.gov/cder/drug/advisory/mifeprex200603.htm; see also CDC Fact Sheet Information about Clostridium Sordellii (Nov. 23, 2005), available at http://www.cdc.gov/ncidod/dhqp/id_Csordellii.html.
The FDA has concluded that a sixth reported death was completely unrelated to the use of the drug or even to abortion. FDA Mifeprex (mifepristone) Information Update (April 10, 2006), available at http://www.fda.gov/cder/drug/infopage/mifepristone/default.htm.
[10] See Grimes, Risks of Mifepristone Abortion in Context at 161.
[11] NARAL, Mifepristone: The Impact of Abortion Politics on Women’s Health and Scientific Research at 3, December 20, 2004.
[12] Finer LB, Henshaw SK. Abortion Incidence and Services in the United States in 2000. Perspectives on Sexual and Reproductive Health, 2003, 35(1): 6–15.
[13] 21 C.F.R. § 314.520, 314.530.
[14] Michael F. Greene, Fatal Infections Associated with Mifepristone-Induced Abortion, 353 New Eng. J. Med. 2317-18 (Dec. 2005).
[15] See September 28, 2000, FDA Center for Drug Evaluation and Research Memorandum to Population Council Regarding NDA 20-687 MIFEPREX (mifepristone) at 6, available at http://www.fda.gov/cder/drug/infopage/mifepristone/memo.pdf (hereinafter FDA September 28, 2000, Memorandum) (listing distribution restrictions); see also 21 C.F.R. § 314.520.
[16] FDA September 28, 2000, Memorandum at 7 (detailing post-marketing study commitments).
[17] FDA September 28, 2000, Memorandum at 6.
[18] FDA September 28, 2000, Memorandum at 4-5.
[19] FDA September 28, 2000, Mifepristone Approval Letter at 2, available at http://www.fda.gov/cder/foi/appletter/2000/20687appltr.htm.