NAF Packet Tells Abortionists How to Ignore FDA Rules on RU486

By Randall K. O'Bannon, Ph.D., NRL Director of Education & Research

Last September when the Food and Drug Administration (FDA) approved RU486, the agency unfortunately dropped several important safeguards vital to protecting women's health. Nevertheless, the FDA held firm on requirements regarding dosage, regimen, and time frame that dispensing abortionists were supposed to follow.There is now evidence that abortionists are ignoring even these basic guidelines, and the National Abortion Federation (NAF) is telling how it can be done.

Illuminating Materials from the NAF Packet

Doctors ordering the NAF's "Medical Abortion Start-Up Packet" receive journal articles, supply and start-up checklists, a staff training guide, the official NAF prescribing protocol, sample consent and referral forms, the official FDA labeling, and FDA-required patient and physician agreements. However, they also receive a form telling them that their signing the FDA " Prescriber Agreement" doesn't preclude their using regimens departing from the FDA guidelines.

The document is entitled "Becoming a Provider of Mifeprex: What Providers Need to Know About the Prescriber Agreement." It informs would-be abortionists that they will have to sign Danco's "Prescriber Agreement" to order the abortion pills. [Danco is the pill's distributor.]

The NAF document relates a number of the qualifications laid down by the FDA, but does not repeat information from the FDA Prescriber Agreement about the appropriate timing for use of the drug (up to 49 days after a woman's last menstrual period) or say anything about the appropriate dosage (three pills at 200 mg each) mentioned in the Medication Guide or the official FDA labeling.

Instead, immediately after stating that the distributor "may discontinue distribution of the drug to any provider who does not follow the guidelines enumerated in the Prescriber's Agreement," NAF launches into a section on "Alternative Evidence- Based Regimens" counseling doctors that Danco's Prescriber's Agreement "neither explicitly forbids or endorses alternative evidence-based regimens."

NAF Outlines Off-Label Use

Though the NAF document does not spell out what an "alternative evidence-based regimen" is, the practice this refers to is the apparantly burgeoning "off-label" use of drugs by physicians who use drugs in ways beyond those for which they were originally designed or approved. The idea is that a physician may use a different or "alternative" dosage, procedure, or application, as long as it is "evidence-based" - - that is, based on studies or data published in some recognized medical journal.

Rather than reinforce the FDA standards for RU486, NAF counsels doctors, "The FDA has recognized that alternative evidence-based uses of drugs by clinicians is often appropriate and may represent the standard of practice." And NAF tells doctors, " Historically, the FDA has not attempted to regulate a clinician's exercise of medical judgement in prescribing approved drugs for off-label or alternative evidence-based uses."

NAF does not say so in this document, but in the NAF protocol included in the packet, it suggests several "Variations Based on Accumulated Scientific Data" which tinker with the dosage, timing, and procedure laid down by the FDA.

Declaring explicitly that "Individual providers are not limited to the uses or regimens set forth in the FDA-approved labeling," NAF lists the following "variations":

* Using 200 mg mifepristone (one pill of RU486) instead of the standard three-pill dose (600 mg) authorized by the FDA for RU486-induced abortions.

* Using higher doses of misoprostol (Cytotec), the prostaglandin used with RU486 to finish the abortion.

* Using the drugs (with higher doses of misoprostol) up to 63 days after a woman's last menstrual period, two weeks beyond the limit set by the FDA.

* Allowing women to take the second drug (misoprostol) at home, rather than having them return to the abortionist's office for the FDA-mandated second visit.

* Starting the whole process as much as a week later and then administering the second drug, at a higher dose, a day earlier (day two instead of day three) or a day later (day four). Day three is prescribed by the FDA.

* Doing the follow-up visit earlier than the 14 days set forth in the Prescriber Agreement and FDA guidelines.

FDA: "Use the product according to the approved regimen"

While researchers do sometimes find and publicize other uses or protocols for drugs beyond those considered by the FDA, what is remarkable in this case is that the government specifically mandated the original protocol and explicitly argued against some of the variations touted by NAF.

The drug application considered by the FDA was specifically for use of 600 mg of mifepristone (RU486) followed by 400 micrograms of misoprostol (Cytotec) for the "medical termination of intrauterine pregnancy through 49 days pregnancy." No other dosages were submitted by the sponsor or studied or approved by the FDA.

The FDA panel considering the drug in July 1996 did note, and later data released on the U.S. trials confirmed, that there was a significant drop off in "effectiveness" after 49 days. While the given dosages were 92% "effective" for 49 days or less, the U.S. trial found that dropped to 83% for an additional week, and was down to 77% at 63 days.

NAF tries to get around this by claiming that the pills are more effective at these later stages when used in higher doses. NAF cites various medical studies conveniently included or referenced in the packet.

Though the studies cited by NAF were published before the FDA approved RU486, the government kept the dosages where they were and continued to maintain the 49-day cutoff point throughout its published patient and physician materials and other official correspondence.

One NAF "variation" - - that women be allowed to take the second drug at home - - was explicitly rejected in an official memo sent to the drug's sponsor on the day of the drug's approval.

In a document the FDA web site titles "Office Memo to Population Council," the FDA says that while it had originally agreed to let women take the misoprostol at home, "data provided by the Population Council supporting home use was re-reviewed and found not to provide substantial evidence for safety and efficacy."

The FDA noted that data supplied by the Population Council was of anecdotal evidence using misoprostol vaginally instead of orally, an observational study of home use in Guadeloupe, and a U.S. clinical trial of home use employing a different regimen and doses.

Only the Guadeloupe study actually addressed whether home use led to correct use, the FDA said, and it found that 4% used it incorrectly. The requirement that patients return on Day Three for the misoprostol, the FDA says, "assures that the misoprostol is correctly administered."

An FDA official told the Wall Street Journal (10/30/00) that while the FDA usually doesn't interfere with the way doctors practice medicine, "People should use the product according to the approved regimen." If the distributor wants to change the dosage or the label, the official said, it would have to submit new data to the FDA for review.

Abortionists May Be Cutting Corners to Cut Costs

There is already evidence that certain clinics and abortionists are following some of NAF's protocols, and their reasons for employing these unauthorized variations are quite illuminating.

Renee Chelian, who runs three abortion clinics in Detroit's suburbs, told the New York Times (12/30/00) that she was considering offering one RU486 pill instead of three to help keep her prices competitive. Danco, the pill's distributor, charges $270 for a full three-pill dose - - about what it costs for a surgical abortion.

This is before additional fees for counseling, ultrasound, or multiple office visits are added on. Using a single pill rather than three enables Chelian to charge only $80 more for an RU486/misoprostol abortion than for a surgical one.

Planned Parenthood President Gloria Feldt told the Wall Street Journal (10/30/00) that "The easiest thing is to follow the FDA regimen exactly," but added that "other alternatives are going to be helpful for patients having difficulty getting to a clinic."

Planned Parenthood's standards, like NAF's, include the modified dosages and the option of home administration, but instructs clinics to call the national office and apply for a waiver if they plan to deviate from the FDA protocol.

Family Planning, one of the largest dispensers of RU486 in California, told the Los Angeles Times (5/31/01) it was using a single pill instead of the designated three-pill dose and using the drugs to induce abortions up through the ninth week. The paper says the clinic charges $130 more for the pill-induced abortions to cover additional drug and office visit costs, making these abortions "slightly more profitable" than surgical ones.

Family Planning tells the LA Times that using a later cutoff date gives it a competitive advantage over clinics adhering to the seven-week standard. "You catch a lot of women in those two [extra] weeks," a spokeswoman told the Times.

NAF: No Legal Responsibility

After presenting its discussion of "off-label" or "alternative evidence-based uses," NAF warns doctors, "When a provider breaches established standards of medical care, he or she is at risk for claims of medical malpractice."

While NAF tries to assure doctors that they should not be liable for malpractice for an off-label use as long as they do not violate the standard of care, NAF tries to insulate itself from any legal liability by claiming its materials are intended only for "informational" purposes. NAF asserts that its materials "do not constitute legal service, advice, or representation" and says "NAF specifically disclaims any liability incurred as a consequence of reliance upon this information."