Obama administration refuses to relax Plan B restrictions

The federal government Wednesday rejected a request to let young teenage girls buy the controversial morning-after pill Plan B directly off drugstore and supermarket shelves without a prescription.

In a rare public split among federal health officials, the Health and Human Services Department overruled a decision by the Food and Drug Administration to make the drug available to anyone of any age without a restriction.

In a statement, FDA Administrator Margaret A. Hamburg said she had decided the medication could be used safely by girls and women of all ages. But she added that Health and Human Services Secretary Kathleen Sebelius had rejected the move.

“I agree ... there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential,” Hamburg said.

“However, this morning I received a memorandum from the Secretary of Health and Human Services invoking her authority under the Federal Food, Drug, and Cosmetic Act to execute its provisions and stating that she does not agree with the Agency’s decision to allow the marketing of Plan B One-Step nonprescription for all females of child-bearing potential,” she said.

In a separate statement and letter to Hamburg, Sebelius said she overruled the FDA because she had concluded that data submitted by the company that makes the drug did not “conclusively establish” that it could be used safely by girls of all ages.

“About 10 percent of girls are physically capable of bearing children by 11.1 years of age. It is common knowledge that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age,” Sebelius said. “If the application were approved, the product would be available, without prescription, for all girls of reproductive age.”

The surprising decision is a stunning blow to some doctors, health advocates, family-planning activists, members of Congress and others who backed relaxing the restrictions to help women prevent unwanted pregnancies.

“We are outraged that this administration has let politics trump science,” said Kirsten Moore of the Reproductive Health Technologies Project, a Washington-based advocacy group. “There is no rationale for this move. This is unprecedented as evidenced by the commissioner’s own letter. Unbelievable.”

Susan F. Wood of George Washington University, who resigned from the FDA in 2005 because of delays in relaxing restrictions on Plan B, said she was “beyond stunned” by the decision.

“There is no rationale that can justify HHS reaching in and overturning the FDA on the decision about this safe and effective contraception,” Wood said. “I never thought I’d see this happen again.”

Opponents had urged the agency to reject the move, saying such a decision would expose girls and women to potential risks from taking high doses of a potent hormone, interfere with parents’ ability to monitor their children and make it easier for men to prey on vulnerable minors.

“This is the right decision based on a lack of scientific evidence that it’s safe to allow minors access to this drug, much less over-the-counter,” said Sen. Charles Grassley (R-Iowa).
The request followed a series of steps in recent years that have gradually made Plan B easier to obtain. Had it been approved, the pill would have moved out from behind pharmacists’ counters, eliminating the requirement that women produce a prescription or prove that they are at least 17 years old to get it without a doctor’s order. Instead, Plan B would have been available on store shelves, along with condoms, contraceptive sponges and spermicides.

Plan B consists of a synthetic form of progesterone; this hormone is found in many standard birth-control pills, but Plan B contains it at higher doses. Taken within 72 hours of unprotected sex, the pill has been shown to be 89 percent effective at safely preventing pregnancy.

The drug has long been controversial and was the focus of one of the biggest health disputes during the administration of President George W. Bush. Plan B works primarily by preventing an egg from being fertilized. Critics, however, focus on the chance that it might prevent a fertilized egg from implanting in the womb, an action they consider equivalent to an abortion. As a result, it has been the subject of intense debate and conflict. Some doctors refuse to write prescriptions for it, some pharmacists refuse to fill requests, and some hospitals refuse to provide it to patients.

The FDA approved Plan B in 1999, but only for women who first obtained a prescription from a doctor. With strong support from women’s health groups and family-planning advocates, the drug’s maker asked the FDA in 2003 to ease the rules to allow totally free sale without a prescription so women would not have to scramble — often in late-night or weekend panics after having sex without protection, having a condom break or being raped — to find a doctor to write a prescription and an open pharmacy to fill it.
Conservative lawmakers and advocacy groups have opposed every request to relax the restrictions on Plan B. They question the drug’s safety and whether young girls and women would use it properly without a doctor’s supervision, and they argue that wider availability could encourage sexual activity and make it easier for men to have sex with underage girls by forcing them to take the drug to prevent any pregnancies that could result.

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.
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 before the decision.
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.