“When anybody can buy an emergency contraceptive like this over the counter, you open the door for all sorts of abuse, and especially so when it comes to child abuse and child exploitation,” said Janice Crouse of Concerned Women of America, another advocacy group.
In addition, by removing the need to see a doctor, women and girls would miss an opportunity to receive diagnoses and treatment for sexually transmitted diseases, and parents would have less influence over their children’s behavior, critics charge.
“Parents have to sign a permission slip for their children to go on a class trip or get their ears pierced,” Crouse said. “When you are talking about selling something like this over the counter, you are opening up a can of worms when it comes to parental involvement in their children’s lives.”
But teen-pregnancy-prevention advocates back the change.
“I appreciate the discomfort some feel about making it easier for teens to get backup contraception,” said Sarah Brown of the National Campaign to Prevent Teen and Unplanned Pregnancy. “The good news is that there is simply no evidence to suggest that making contraception available to teens encourages them to begin having sex, have sex at younger ages or have more sexual partners. Moreover, most of us would rather have sexually active teens use contraception than become pregnant.”
Delay sparks criticism
The FDA delayed a decision on the original request to relax the need for a Plan B prescription for three years, despite endorsements of nonprescription sales by its outside advisers and internal reviewers. The delay spurred intense criticism during Bush’s administration that the agency was allowing politics to influence the decision.
The agency eventually approved nonprescription sale of Plan B
in August 2006, marking the first time a hormonal contraceptive was made broadly available in the United States without a prescription. Proponents, however, were disappointed that the drug was limited to women age 18 and older and sued the FDA.
Three years later, the agency allowed the sale of Plan B One-Step, a new version that works with one pill instead of the original two, to 17-year-olds without a prescription. But the decision came only after a federal judge ordered the FDA to make the change, ruling that the restrictions were imposed for “political and ideological” reasons.
In February, Teva Pharmaceutical Industries asked the agency to drop the remaining restriction, citing the results of two new studies. One involving 335 girls ages 12 to 17 showed that between 72 percent and 96 percent of them understood the proposed package label well enough to use the drug safely and effectively on their own. The second, involving about 300 girls ages 11 to 16, showed that they could use the product properly and safely, according to Teva.
“We have a tremendous amount of safety information regarding this particular product. It is classified as very, very safe,” Teva’s Amy Niemann said. “Hopefully, we’ll get full approval. It would be an historic and important decision for women.”
The lawsuit that spurred the FDA’s relaxation of restrictions is pending. A hearing is scheduled for Dec. 13 on a motion to declare the agency in contempt of court for failing to review its decision to leave age restrictions in place.
Another morning-after pill, Next Choice, the generic version of the original two-pill Plan B that sells for about $35, is available only by prescription.
“We think it’s important for both the original two-pill as well as the new one-pill One-Step to be available to all women of all ages,” said Nancy Northrup of the Center for Reproductive Rights, which filed the suit. “It’s especially important for younger women, for whom cost can be an important issue.”