RU-486: The Impact of Possible FDA Restrictions on its Use & Distribution

The fundamental right to choose is a reality only when there is access to safe and effective methods of abortion. RU486, also known as mifepristone, is one of the most important technological advances for abortion. It promises to expand access by providing women and their doctors with a more private means of terminating pregnancies than surgical abortion. Yet, this imperative technology has been consistently undercut by anti-choice politics and the climate of fear perpetuated by anti-choice violence. Although RU486 is described as the moral property of women, American women have been waiting ten years to gain access to it. The approval process simply is taking too long.

We know that RU486 is safe and effective. It was approved for distribution 12 years ago in France, and is widely available in Europe. Suppliers of the drug say more than 600,000 women have used it worldwide. Four years ago the FDA adjudicated RU486 approvable in terms of its safety and effectiveness. The FDA also has permitted clinical trials of the drug. Really, all that remains are issues regarding labeling and distribution.

Although the FDA has jurisdiction over labeling practices, it would be inappropriate for the FDA to enact restrictions on the distribution of RU486. Restricting RU486 distribution to those who are trained to provide surgical abortions, medical abortions and sonograms, and those who have admitting privileges to a hospital emergency room within one hour of a patient’s residence, would exceed the FDA’s authority.

The FDA itself has said, “Congress did not intend the [FDA] to interfere with medical practice . . . [or] to regulate the practice of medicine as between the physician and the patient.” A restriction that imposes special training and experiential requirements on medical professionals who seek to prescribe mifepristone, in essence, regulates the practice of medicine. Regulation of the practice of medicine is a matter for the states. Nothing in the FDA’s authorizing statute empowers the agency to impose such restrictions. To the contrary, it is well established that “the FDA does not have jurisdiction to regulate the administration of a drug by a physician.” Indeed, the FDA itself recognizes that “the physician may, as part of the practice of medicine, lawfully prescribe a different dosage for his patient, or may otherwise vary the conditions of use from those approved in the package insert,” without obtaining FDA approval.

According to the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 301), the FDA may refuse an application if it finds “the manufacture, processing, and packing of such drug are inadequate to preserve its identity, strength, quality, and purity.” However, federal courts have repeatedly held that the FDA may not dictate which medical providers may distribute particular drugs. One federal case, American Pharmaceutical Association v. Weinberger, 377 F. Supp. 824 (D.D.C. 1974), aff’d, 530 F.2d 1054 (D.C. Cir. 1976), is particularly instructive.

American Pharmaceutical concerned the FDA’s attempt to restrict the distribution of methadone to “approved maintenance treatment programs” or “approved hospital pharmacies.” The court held that such regulations exceeded the FDA’s authority because the FDA had no separate authority to regulate distribution. The court noted that once the FDA has determined that a drug is safe and that its manufacture and packing are adequate to preserve its identity, strength, quality and purity, the FDA must approve the application. Again, keep in mind that four years ago the FDA determined mifepristone to be safe and effective.

New York, like every other State, has its own legislation that governs who can practice medicine and to what extent. In order to combat a health care provider shortage, New York created the professions of Physician Assistant, Nurse Midwife, and Nurse Practitioner. These advanced health care practitioners have extensive medical training and wide-ranging scopes of practice that depend largely on their practice agreements with supervising or collaborating physicians. In addition, they are authorized to prescribe and dispense a broad range of medicine under New York law. The FDA does not have the authority to regulate RU486 in a manner that would impinge on the ability of Physician Assistants, Nurse Midwives and Nurse Practitioners to serve their patients under the authority granted to them by the State.

Restricting RU486 distribution to those who are currently trained to provide surgical abortions and who have admitting privileges to a hospital within an hour of a patient’s residence would undermine significantly New York’s efforts to expand health care access and would vitiate the potential benefits of medical abortion. There are a strikingly small number of abortion providers in the United States. New York alone lost 23 abortion providers between 1992 and 1996 – an 8% loss. And, 42% of New York counties have no abortion provider. That means that women in some rural areas have to travel for hours and pay costly travel expenses before they can exercise their constitutional right to choose. RU486 could expand access for women in counties that do not have an abortion provider. A recent Kaiser study found that one in three gynecologists who don’t currently perform abortions would prescribe mifepristone. Women would be able to continue care with their own providers rather than being forced to travel to outside clinics. Women also would be able to avoid the emotional abuse dished out by anti-choice groups at abortion clinics by getting treatment in the privacy of their own doctor’s office. However, if distribution of RU486 is restricted to current abortion providers, women will have to travel to the same distant clinics and suffer the same anti-choice harassment. Moreover, if the FDA insists that misoprostol, the drug that is taken after mifepristone, be administered in the presence of a “certified provider,” women will have to make yet another trip to an outside facility.

There is great potential for RU486 to augment women’s access to safe and effective reproductive health care. It is important that the FDA not undercut this extraordinary technological advance for abortion. RU486 should be available for medical practitioners who are not prepared to go through the procedural and regulatory hoops to provide surgical abortion procedures. We know that RU486 is safe and we know that it is effective. Indeed, only 5% of the women who take this pill need further treatment. It’s time that politics stopped hindering American women’s ability to obtain mifepristone — a drug that will give them the means to terminate their pregnancies early, safely and privately. It’s time that we improve women’s access to reproductive health care so that the promise of reproductive choice is fulfilled in reality. It’s time that we take a step forward – finally – to ensure that women can make the difficult and intimate decision of whether to continue a pregnancy to women. RU486 has the potential to help us do that.