NRLC Memo to Journalists:  Issues Surrounding Imminent 
FDA Action on the Abortion Pill, RU-486

To:     Journalists

From: Laura Echevarria, NRLC Media Relations Director,
            (202) 626-8825, cell (202) 531-1996, NRLCMedia@aol.com

            Douglas Johnson, NRLC Federal Legislative Director
            Randall K. O'Bannon, Ph.D., NRLC Education Director

Re:     FDA action this week on RU-486

Date:  September 24, 2000

This week -- probably no later than Thursday, September 28 -- the Food and Drug Administration (FDA) will make an important announcement regarding the long-pending application of Danco Laboratories (a creation of the Population Council) for approval to market the RU-486 abortion pill in the United States. For several weeks, various sources in the abortion industry have been telling journalists that they expect that the FDA will authorize the distribution of RU-486. However, it is also possible that the FDA will again announce that certain issues remain to be resolved, as the agency did in February.

The National Right to Life Committee (NRLC), the nation's major right-to-life organization, will distribute a statement as soon as possible after the FDA announces its decision, and NRLC spokespersons will be available for interviews.

If approval for distribution is granted, Danco will step up its sophisticated marketing and public-relations campaign "aimed at swiftly building market share," according to a revealing report that appeared in the Sept. 5 Wall Street Journal. According to the article -- drawing on leaked internal Danco documents -- "[t]he company has tentatively picked the brand name Early Option for the drug, based on women's response's in focus-group surveys," and anticipates sales of $34.2 million by 2004.

The people running the RU-486 PR campaign hope that journalists can be persuaded to adopt the campaign's loaded terminology and uncritically accept their set of "medical facts," thereby reinforcing the marketing strategy. But skepticism is warranted. If the FDA does in fact approve marketing of the RU-486 abortion pill this week, here are several points of information and questions that should inform press coverage of the event.

* How will the FDA handle the use of Cytotec? RU-486 has a low success rate unless it is used in combination with a powerful prostaglandin drug, misoprostol, marketed by Searle under the trade name Cytotec. Cytotec is approved as a treatment for ulcers, and Searle has objected to its use for abortions. See "Searle Warns Against Use of Cytotec in Abortions," www.nrlc.org/news/2000/NRL09/randy.html.

*  "Drug-induced abortion" is an accurate and neutral term, while "medical abortion" is confusing and seriously misleading. It appears to be a key element of the abortion industry's marketing strategy to persuade journalists to stop calling RU-486 an "abortion pill," and to adopt the contrived marketing term "medical abortion." In reality, drug-induced abortions are no more or less "medical" than surgical abortions. The term "medical abortion" falsely suggests an abortion performed because of some medical need, when in fact RU-486 will be used almost exclusively for routine, birth-control abortions.

* It is grossly inaccurate to state, as some journalists have, that the RU-486/Cytotec method causes the expulsion of a "fertilized egg." The FDA apparently plans to approve the RU-486/Cytotec method up to 49 days "LMP" (i.e., after a woman's last menstrual period, which is 35 days after the life of a new human being has begun at fertilization). By the time that a woman misses her period and has a positive pregnancy test, and thus might consider obtaining a drug-induced abortion, she is at least two weeks and in most cases three weeks or more past fertilization (thus, four or more weeks past her LMP). Thus, the baby is two weeks or more past the "fertilized egg" stage. By the time a woman's pregnancy test shows positive, she carries already implanted within her womb a human being defined in technical medical terms as an "embryo." The abortion-drug combination kills this human embryo by cutting off nourishment and then inducing uterine contractions.

* Every RU-486-induced abortion that occurs three weeks or more past fertilization -- which undoubtedly includes the great majority of such abortions -- stops a beating heart. Embryology textbooks say that the heartbeat begins at 18 to 22 days after fertilization, so if RU-486 is used to abort at the 49-day LMP cutoff (five weeks after fertilization), the baby's heart has been beating for about two weeks.

* An ABCNEWS.com poll conducted Sept. 6-10 found that a plurality of Americans believe that RU-486 should remain "illegal" (47% illegal, 45% legal). The Clinton-Gore Administration, which claimed it wanted to make abortion "rare," is now about to approve marketing of an abortion pill that may kill increasing numbers of unborn babies and pose new dangers to women. For a detailed, footnoted monograph summarizing the history of efforts to win approval of RU-486 under the Clinton-Gore Administration, see "RU486: The Pill, The Process, The Problems," at the NRLC website, www.nrlc.org/RU486/ru486all.html.

* Will the FDA bow to the pro-abortion pressure campaign and dilute women's safety regulations proposed earlier? According to press accounts, in early June representatives of the Population Council and Danco revealed that the FDA was proposing a number of restrictions on the marketing of RU-486, in order to protect women's health. These restrictions included requiring prescribing physicians to be trained in the reading of ultrasounds and limiting use to doctors with admitting privileges to hospitals with emergency services within an hour's drive of the doctor's office. Since then, the abortion industry and pro-abortion ideological groups have waged an intense pressure campaign to persuade the FDA to dilute or drop those restrictions. This week, we may learn whether the FDA has caved in to this campaign. For details on the restrictions earlier proposed by the FDA and the medical evidence justifying each proposed restriction, see "Description of Restrictions Proposed by FDA for RU-486," www.nrlc.org/RU486/ProposedFDAregs.html.

* The RU-486/Cytotec method poses serious health risks to women. Even under the controlled conditions of clinical trials, the RU-486/Cytotec process puts one out of every 100 users in the hospital. Two percent of women have such severe bleeding they need surgery. During U.S. trials, one woman in Iowa nearly bled to death.

* Will the abortion pill be imported from China? A report in the Sept. 5 edition of the Wall Street Journal, based in part on leaked documents from Danco Laboratories, suggests that Danco may have arranged with the People's Republic of China to produce the abortion pills that will be sold in the U.S.. If this is true, it raises a number of serious new concerns relating to women's health. While the FDA may refuse to confirm whether China is the source of the pills, journalists should insist that Danco confirm or deny that the pills are being imported from China. In hearings earlier this year, members of the U.S. House Commerce Committee's Oversight Subcommittee criticized the FDA for failing to adequately protect the public from dangerously tainted imported drugs, and China was named as a major problem in this regard. The subcommittee has another hearing on the subject of imported drugs scheduled for October 3, at which FDA Commissioner Jane E. Henney will testify. (For discussion of the possible China connection and other recent developments, see "RU-486 Approval Imminent?," by Randall O'Bannon, Ph.D at www.nrlc.org/news/2000/NRL09/china.html.