FDA puts off decision on ‘morning after’ birth control

WASHINGTON – After 28 months of growing controversy, the Food and Drug Administration on Friday indefinitely postponed its decision on whether women should be allowed to buy the “morning after” birth control pill without a prescription – despite earlier assurances that it would act by Sept. 1.

The decision to embark instead on a new regulation-writing process was immediately denounced by women’s health advocates and some lawmakers as a stalling tactic. A formal rule-making generally takes years to finish.

FDA Commissioner Lester Crawford acknowledged that the agency’s drug review staff had concluded the drug – which is marketed under the name Plan B – could be safely used as an over-the-counter drug by women over 17. But in an unexpected twist, Crawford also said the application raised complicated and unresolved issues about whether current regulations allow a drug to be legally sold by prescription only for teens but over-the-counter for all others.

“What we’re saying today is that there are unique regulatory issues here that need to be addressed before we can make a decision on this application,” Crawford said. He said he could not estimate how long that might take.

Sens. Hillary Clinton, D-N.Y., and Patty Murray, D-Wash, said they were incensed because they had allowed Crawford’s nomination as commissioner to move forward this summer only after getting a promise that a final decision on the Plan B issue would be made by Sept. 1.

“I am stunned and outraged and furious,” Murray said. “This is not only a broken promise to us, but another frightening example of politics trumping science at the FDA.”

Many social and religious conservatives oppose easier access to emergency contraception and have flooded the White House with their views in recent days. Some oppose the easier access because they believe it will encourage promiscuity among young girls, and others because they believe emergency contraception can be a form of abortion.

Wendy Wright, policy director for Concerned Women for America, who has led the opposition, welcomed Crawford’s announcement.

“I believe the FDA is being sensitive to the fact that this drug is not like others,” she said. Plan B is considered a contraceptive by the FDA and mainstream medical organizations, who define pregnancy as the point where a fertilized egg is implanted in the uterus. The FDA has also concluded that easier access to emergency contraception – which generally must be taken within 72 hours of unprotected sex – would substantially reduce the number of unwanted pregnancies and abortions.

But others who believe that pregnancy begins at the point that the egg is fertilized argue that drugs such as Plan B can cause an abortion, since in some circumstances they prevent a fertilized egg from implanting.

Plan B, which is a concentrated form of a standard contraceptive, was approved by the FDA in 1999 as a prescription-only drug. Four years later, an FDA advisory panel voted 23-4 in favor of an application from drug maker Barr Laboratories to make Plan B available without a prescription.

The FDA rejected the application in May 2004, however, saying there was insufficient information on whether the drug is safe for use by girls under 16. At the time the FDA advised drug maker Barr Laboratories to submit another application that allowed OTC sales only to women over 17. That was the plan that was deemed to be impossible to resolve Friday.