FDA to Decide Status of Morning-After Pill
Agency Nears Decision on Over-the-Counter Sale of Drug Known as 'Plan B'
WebMD News Archive
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?