FDA Delays Ruling on ‘Morning After’ Contraceptive

Federal regulators Friday balked at deciding whether to make the “morning after” birth control pill available without a prescription, saying that, though it is safe, proposed restrictions on teenage girls’ access to the drug have raised legal issues.

The Food and Drug Administration had promised a decision on the politically charged question by next Thursday. But FDA Commissioner Lester Crawford said he was postponing a decision until the agency could formally gather comment on whether age is a valid justification for requiring girls 16 and younger to get a prescription for the contraceptive, which is marketed under the name Plan B.

Crawford said he would expedite the regulatory deliberations, suggesting they would take months, not years.

The drug has raised “many difficult and novel policy and regulatory issues,” Crawford said at a news conference. “We need to resolve these policy and regulatory questions before we can reach a decision on the underlying science.”

Plan B is available by prescription across the country. The drug works mainly by preventing a woman’s ovary from releasing an egg -- it also may prevent fertilization of an egg or prevent a fertilized egg from implanting in the womb -- in contrast to RU-486, the combination used to chemically induce an abortion early in a woman’s pregnancy.

In California and six other states, Plan B can already be purchased without a prescription by asking a pharmacist. These states have used their authority to regulate pharmacies to circumvent the FDA.

Proponents of making Plan B as available as condoms say it can prevent unwanted pregnancies and reduce abortions. Opponents liken it to an abortion drug and warn that easier access would increase sexually transmitted diseases and facilitate the exploitation of young women.

Lorraine J. Tulman, a member of the panel that advised the FDA in 2003 to make Plan B available without a prescription, said the agency’s announcement appeared to be tainted by politics.

“I think the administration is trying to please all sides, by saying ‘Yes, we recognize the science’ and on the other hand trying to appease its own base,” said Tulman, an associate professor at the University of Pennsylvania School of Nursing. “They will wind up pleasing neither.”

Opponents of broadening the availability of Plan B include many social conservatives, who make up part of the Bush administration’s core constituency.

“This is Washington -- it’s not surprising things are political,” Tulman added.

“The bottom line is they couldn’t deny it based on scientific grounds. Therefore, one must retreat into the bureaucratic mode and deny it on some regulatory technicality,” she said.

Officials at the Health and Human Services Department have said the decision has been treated as a regulatory matter all along and has been left in the hands of FDA experts.

The key issue before the agency is whether an age restriction is enforceable, Crawford said.

“FDA cannot have an inspector in every pharmacy,” he explained. “We need to make sure the states ... can take the text of this approval and sculpt a system that allows for its enforcement.”

FDA scientists have determined that Plan B is safe for women 17 and older, Crawford said. The concern about younger teenagers has nothing to do with any biological differences between younger and older women. “The question is, at what age do they have the ability to interpret the instructions?” Crawford said.

Age restrictions will prove unenforceable, said Wendy Wright, senior policy director for Concerned Women for America, a conservative organization that opposes allowing Plan B to be sold without a prescription.

“It is naive to assume any over-the-counter scheme for the morning-after pill would be effective,” Wright said. “A 17-year-old could buy it for a 13-year-old girl. Or worse yet, a pedophile could purchase this drug for his victims.”

Crawford’s announcement was the latest turn in the convoluted regulatory journey of Plan B.

The FDA advisory panel that Tulman served on in 2003 overwhelmingly recommended allowing over-the-counter sales. A few months later, the agency overruled its scientific advisors, saying that manufacturer Barr Laboratories had failed to supply enough evidence that girls younger than 16 could use the drug safely.

The agency invited Barr to reapply for approval, suggesting a requirement that younger girls have a prescription. Barr did so, but the FDA still did not rule.

Earlier this year, the delay prompted Sens. Hillary Clinton (D-N.Y.) and Patty Murray (D-Wash.) to block a floor vote on Crawford’s nomination to head the agency. They relented after the FDA agreed to announce its decision by Sept. 1. On Friday, the two senators said the FDA’s announcement was “a breach of faith.”

Sen. Edward M. Kennedy (D-Mass.), who supported Crawford’s appointment, said he was disheartened.

“I am disappointed that FDA waited until this late hour to address a legal question that could and should have been resolved months ago,” Kennedy said.

In 1999, the FDA approved Plan B as an emergency contraceptive available by prescription. If taken according to instructions, it is 89% effective in preventing pregnancy, studies show.

The medication consists of two high-dose contraceptive pills. One pill must be taken within 72 hours of unprotected sex, and preferably within 24 hours. The second pill is taken 12 hours later. The two-pill packet costs about $30.

No deaths have been reported among women using Plan B. The most common side effects are nausea, headache and fatigue. In rare instances, particularly if the drug is taken too late, it can result in an ectopic pregnancy, a condition in which the egg implants the fallopian tube, not the uterus. That can lead to life-threatening complications.