Plan B One-Step restrictions are lifted

The Obama administration on Monday abandoned its attempt to restrict access to the emergency contraceptive Plan B One-Step (Teva Women’s Health Inc.) as an over-the-counter (OTC) medication-a decision that’s being celebrated by some groups.

FDA had previously only approved Plan B One-Step without a prescription for women 15 years and older without a prescription. That decision was based on an actual use study and label comprehension data submitted by Teva Women’s Health Inc., the drug’s manufacturer. Both found that women as young as 15 understood Plan B One-Step did not protect against sexually transmitted diseases and was not for routine use.

Facing federal court litigation by several groups, the administration reversed its stance and announced that FDA and the Department of Health and Human Services would remove point-of-sale restrictions on Plan B One-Step, making it readily available to all women. FDA has not approved OTC access to a 2-pill Plan B alternative. It maintains that the two-step alternative needs to be taken in consultation with a healthcare professional until evidence proves otherwise.

The decision was praised by one of the plaintiffs in the federal court case. “Now that the appeals court has forced the federal government’s hand, FDA is finally taking a significant step forward by making Plan B One-Step available over the counter for women of all ages,” Nancy Northup, president and chief executive of the Center for Reproductive Rights said in a statement. “But the Obama administration continues to unjustifiably deny the same wide availability for generic, more affordable brands of emergency contraception.”

Others believe the availability of the drug undermines parental rights. FDA’s decision may not end the legal battle as the presiding judge in the case, US District Judge Edward Korman, has previously written that the administration was “politically motivated” and that the drugs should be available without prescriptions to everyone.