FDA to Decide Status of Morning-After Pill
Agency Nears Decision on Over-the-Counter Sale of Drug Known as 'Plan B'
Aug. 18, 2005 - Plan B may be the best-named drug in the pharmacy. That's because the so-called "morning-after" pill isn't anybody's plan A.
But the story now is what the FDA plans to decide about the drug by the end of the month. Will the agency allow the drug to be sold over the counter?
Plan A is the plan in family planning -- the plan for when or whether a couple wants to have a baby. When plan A fails -- that is, when a condom breaks or when a couple has sex without using birth control -- there's plan B.
Plan B is emergency contraception, commonly known as the morning-after pill. There are two FDA-approved emergency contraceptive products. One is Preven from Gynetics Inc. The other is Plan B from Barr Laboratories.
Politics vs. Science
In December 2003, a meeting of two FDA advisory panels voted 23-4 in favor of letting drugstores sell Plan B without a prescription. But in May 2004, the FDA did something rare. Against the advice of nearly all of its outside experts, it said Plan B must remain a prescription drug.
The FDA cited concerns that Plan B had not been tested in enough women under the age of 16. So in July 2004, Barr went back to the FDA, asking the federal agency to approve over-the-counter sales of Plan B for women 16 and older.
A decision on this application was expected last May. It didn't come. The American College of Obstetricians and Gynecologists accused the FDA of playing politics with a scientific decision.
Last month, Health and Human Services Secretary Michael O. Leavitt said the FDA would announce a decision by Sept. 1. Politics had a lot to do with that. Sen. Hillary Clinton (D-N.Y.) and Sen. Patty Murray (D-Wash.) placed a hold on the Bush administration's nominee for FDA chief. They said they'd release the hold when the FDA acted on Plan B, which they did when Leavitt declared the Sept. 1 target date.
Plan B, like any drug, has risks and benefits. What are they?