FDA’s Rules for ‘Morning After’ Pill Blasted by Federal Court; Was the Agency Putting Politics Before Science?

The Food and Drug Administration must reconsider its position limiting access to the controversial “morning after” pill and give the contraceptive to 17-year-olds and younger without a prescription, a federal court said.

The Plan B pill, also called the morning after pill, works to prevent unwanted pregnancy when taken within 24 hours of sexual intercourse. The contraceptive is available without a prescription to women over 18, but the FDA has required women 17 and younger to get a prescription from a doctor for the drug.

The U.S. District Court for the Eastern District of New York, in a ruling issued today, ordered the FDA to make Plan B available to girls 17 and younger without prescriptions within 30 days. The court also ordered the agency to reconsider its decision to make Plan B available only behind the counter, meaning women of all ages who want the pills must ask a pharmacist for it.

Plan B, as it is called in the U.S., is sold by New Jersey-based Barr Pharmaceuticals Inc.

The court’s ruling came in response to a lawsuit brought by the Center for Reproductive Rights and others whose appeal to the FDA to make Plan B available to women of all ages without a prescription was denied by the agency. The groups filed their suit in 2005.

Are Politics or Science Guiding the FDA Policy?

Plan B’s release in the United States was repeatedly delayed due to intense pressure on then-President George W. Bush from anti-abortion forces. The drug eventually was approved, but only after age-based limits on its use had been instituted.

The federal court has now ruled that those age-based limitations must be changed. The court accused the FDA under President Bush of “repeatedly and unreasonably” delaying issuing a decision on Plan B and allowing politics to cloud its scientific policies.

“These political considerations, delays, and implausible justifications for decision-making are not the only evidence of a lack of good faith and reasoned decision-making,” wrote U.S. District Judge Edward Korman. “Indeed, the record is clear that the FDA’s course of conduct regarding Plan B departed in significant ways from the agency’s normal procedures regarding similar applications to switch a drug product from prescription to non-prescription use.”

Teen Pregnancy Officials Praise Decision

Nancy Northrup, president of the Center for Reproductive Rights, praised the court ruling for “recognizing that the FDA favor favored politics over science, ideology over women’s health, and violated the law in the process”, said in a statement.

Northrup called the pill and other forms of emergency contraception “proven safe and effective.”

Improved Access Will Limit Unwanted Pregnancies

The court ruling to increase access to Plan B to all women without a prescription will help prevent unwanted pregnancies. Underage girls who were denied the pill without a prescription and older women who were turned off by having to ask a pharmacist for the pill kept behind the pharmacy counter will benefit from the court’s ruling. Meanwhile, the Bush administration’s growing track record of allowing social and religious forces to dictate important political and scientific decisions has once again been exposed.

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