FDA considers abortion pill restrictions

August 1, 2000

Pharmaceutical Representative

The Food and Drug Administration may consider restrictions on how the abortion drug mifepristone may be administered if it is approved, a move that could have an effect on the number of doctors who are willing to prescribe it.

The Food and Drug Administration may consider restrictions on how the abortion drug mifepristone may be administered if it is approved, a move that could have an effect on the number of doctors who are willing to prescribe it.

Mifepristone induces spontaneous abortion when administered in early pregnancy and followed by misoprostol.

Restrictions may include requiring doctors to be certified and approved to dispense the drug and requiring approved doctors to be qualified to perform surgical abortions and have admitting privileges at a hospital within an hour's drive of the doctor's office.

Reacting to the possible restrictions, Planned Parenthood President Gloria Feldt said, "The level of concern has ratcheted up to a much higher level. What the FDA is talking about would so violate physician's privacy and security concerns that mifepristone could be approved by the agency but never really be on the market."

Feldt's concerns are backed by a survey conducted by The Henry J. Kaiser Family Foundation. In the survey of 767 women's healthcare providers, "Views of Women's Health Care Providers on Abortion: An Update on Mifepristone, And What Happens After FDA Approval," 39% of gynecologists who initially said they were likely to prescribe mifepristone and 32% of family practice physicians would be less likely to prescribe the drug if the FDA required facilities for patients to stay in for as long as four hours following its administration.

Similarly, if the FDA required providers to go through a training program and follow the labeling exactly while administering the drug, 46% of gynecologists and 40% of family practice physicians who were likely to offer the drug said they would be less likely to prescribe it.

According to Planned Parenthood, more than 500,000 women worldwide have used mifepristone without significant serious side effects. PR

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