Suggested FDA restrictions might curtail access to mifepristone

Discussions continue with federal agency toward drug approval

The long road to availability of mifepristone for American women has taken a sharp detour as the Food and Drug Administration considers new restrictions that could hamper access to the medical abortion method when it receives final FDA approval.

"The FDA’s initial approach is more restrictive than we had envisioned for a drug that has been used safely by so many women around the world," says Heather O’Neill, spokeswoman for the New York City-based Danco Group. Danco is the company charged with manufacturing and distributing mifepristone by the owner of the drug’s U.S. license, the New York City-based Population Council.

While those involved in the negotiations declined to give specific details of the proposed restrictions, proponents of abortion access fear that any restrictions will limit access to the drug should it receive FDA marketing clearance. The agency has issued two "approvable" letters — one in March 1996 and the second in February 2000 — declaring the drug’s safety and efficacy.

Vicki Saporta, executive director of the National Abortion Federation (NAF) in Washington, DC, says, "What the FDA is now proposing in terms of restrictions are even more strict than the restrictions that were in place during their own clinical trial. That is fairly unprecedented, since they have already ruled that this drug is safe and effective for use in terminating pregnancy."

The FDA declined to comment on the restrictions. According to FDA spokeswoman Susan Cruzan, the agency is not in a position to comment on a product application. "For any new product, FDA’s job is to examine not only whether that product is safe but also whether it can be used safely," she states.

No registry planned

Initial reports of the suggested restrictions stated that the FDA would maintain a national registry of mifepristone providers, a move immediately questioned by abortion access advocates. Requiring a listing of physicians and patients would be an invasion of privacy, says Mitchell Creinin, MD, director of family planning and family planning research and associate professor in the department of obstetrics, gynecology, and reproductive sciences in the University of Pittsburgh School of Medicine. Such an invasion would deter the drug’s use, which is the opposite of the FDA’s mission, he maintains.

The FDA has not proposed a registry, says Sandra Arnold, vice president for corporate affairs at the Population Council. News of such a registry is a "mischaracterization," she said during a recent Emerging Issues in Reproductive Health media conference on medical abortion, part of an ongoing series for journalists organized by the Kaiser Family Foundation of Menlo Park, CA.

One restriction now in discussion centers on certification of mifepristone providers. If the restriction addresses training, then NAF’s current educational efforts should provide ample coverage without a specific mandate from the FDA. NAF developed a wide variety of educational and training programs to coincide with the launch of mifepristone in the United States, says Saporta. (For an overview, see Contraceptive Technology Update, May 2000, p. 53.)

"We don’t believe that the training should be government-mandated," she explains. "It wasn’t even in [the FDA’s] own clinical trial."

NAF has a journal supplement on mifepristone that will be printed this month in the American Journal of Obstetrics & Gynecology. Its training slides, interactive CD-ROM, and self-study guide will be available pending FDA approval to allow the final labeling to be incorporated in the educational material.

A NAF-sponsored Web site, www.earlyoptions. org, offers detailed information on mifepristone, including its history worldwide, experience with the drug, regimens, side effects, and the availability of mifepristone in the United States, says Saporta. It also includes information about NAF’s "early options" educational materials, with ordering information to be added upon marketing approval. (See resource box, p. 91, for NAF contact information.)

A soon-to-be added section will instruct women on how to access information and materials, as well as direct them to NAF’s telephone hotline, (800) 772-9100. When the drug is available, hotline operators will be able to refer women to qualified providers in their area, notes Saporta.

Restrictions questioned

Another proposed constraint would call for mifepristone providers to be certified in surgical abortion. Advocates do not believe such a limitation should be established. Just 2% of women who had a mifepristone abortion 49 days following their last menstrual period in clinical trials required hospitalization, surgical intervention, and/or intravenous fluid administration.1

"We don’t think that it should be limited to those who can provide surgical abortions because physicians who would like to add it to their practices can always work out an arrangement with a surgical provider to arrange the backup that is necessary," Saporta states.

There is no certification process in existence now for surgical providers of abortion, nor does there need to be any state certification of abortion providers, she adds. Legal induced abortion is the most frequently performed and one of the safest surgical procedures in the country.2 Adding additional legislation would only hinder access for women, she notes.

"We would like to see mifepristone achieve its promise of expanding accessibility to women," she says. "The current restrictions that are being proposed by the FDA would disqualify/qualify physicians and would even disqualify some current providers of surgical services from offering this service to women, thereby denying access to hundreds of thousands of women."

One in three gynecologists who have never performed a surgical abortion or haven’t done so in the past five years say they would use mifepristone for medical abortions, according to a just-released survey from the Kaiser Family Foundation of Menlo Park, CA.3 Slightly more than 30% of family practice physicians, most of whom do not provide abortions, say they, too, would offer the drug. In this survey, 26% of all gynecologists said they routinely or currently perform abortions, while only 5% of family practice physicians said they provide such services.

However, some providers would have second thoughts about providing mifepristone if they were required to undergo a certified training program or were mandated to strictly adhere to product labeling, the survey results reveal. Almost half of gynecologists who said they were likely to offer the drug would be less likely to do so under those conditions, as would 40% of family practitioners.

If mifepristone provision required additional malpractice insurance, many providers would be less likely to offer the drug. Survey results showed that 54% of gynecologists and 60% of family practice physicians who expressed inter-est in providing the drug would be disinclined to do so if extra insurance were required.

The FDA has three options before Sept. 30: It can give its approval to the U.S. manufacture and marketing of mifepristone, decline such approval, or issue another "approvable" letter, says O’Neill. "The issues they have raised will require additional responses from us," she notes. "We’ll just keep discussing [those issues] with them until we reach agreement."

Saporta calls for closure on the issue. "The FDA really needs to approve this drug on Sept. 30, and they need to approve it without politically motivated restrictions that aren’t medically necessary," she says. "While we need to make sure that physicians are educated in this method, and we are prepared to do that, it is important that as many women as possible who want access to the medication are able to have it."

References

1. Spitz IM, Bardin CW, Benton L, et al. Early pregnancy termination with mifepristone and misoprostol in the United States. N Engl J Med 1998; 338:1,241-1,247.

2. Henry J. Kaiser Family Foundation. Abortion Fact Sheet. Menlo Park, CA; May 1999.

3. Henry J. Kaiser Family Foundation. National Survey of Women’s Health Care Providers on Abortion. Menlo Park, CA; June 2000.

National Abortion Federation, 1755 Massachusetts Ave. N.W., Suite 600, Washington, DC 20036. Telephone: (202) 667-5881. Fax: (202) 667-5890. Web: www.prochoice.org.