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Doctors: FDA Threatens Strategy To Manage High-Risk Pregnancies

MANAGED CARE May 1998. © MediMedia USA
News and Commentary

Doctors: FDA Threatens Strategy To Manage High-Risk Pregnancies

MANAGED CARE May 1998. ©1998 Stezzi Communications

A group of physicians calling itself the "Terbutaline Strategy Group" has petitioned the U.S. Food and Drug Administration to reverse itself, after the agency mailed a "Dear Colleague" letter warning practitioners about use of terbutaline sulfate for prevention of preterm labor. The doctors worry that the FDA action could remove one of their most effective — and cost-effective — strategies for managing tens of thousands of high-risk pregnancies outside of the hospital each year.

Subcutaneous terbutaline therapy for preterm labor — an off-label use of a drug approved for treatment of asthma — has spread in recent years, as studies have demonstrated safety; in 1993, the FDA asked terbutaline manufacturers to remove pregnancy contraindications from product labeling. But in its letter last November, the FDA questioned the methodology of some of those studies. The 1995 death of a woman receiving this therapy appears to have prompted the FDA's concern, though her death has not been linked to terbutaline use.

Fung Lam, M.D., a San Francisco perinatologist who pioneered the therapy and one of the physicians petitioning the FDA, says only a few drug therapies exist for at-home management of preterm labor — and all are off-label. "None is without complications. Is the FDA going to issue warnings for other medications, too?" he asks. "We want to continue to prescribe judiciously, the way we always have."

Lam, a district chairman of the American College of Obstetricians and Gynecologists, is also concerned health plans will be frightened away. "For the last five to ten years, we have been working diligently with payers on this," he says, and with neonatology stays costing up to $3,000 a day, "Over time, more of them have been covering it."

But Sidelines, which provides support to women with high-risk pregnancies, says patients have notified it of at least five HMOs that have either stopped or restricted coverage, and five more are considering doing so. Lam says the more hospitals that are capitated by HMOs for obstetrical care, the more likely plans are to drop coverage: "HMOs have no incentive to pay for outpatient services."

The FDA has not responded to the petition.