Age Issues Delay FDA Ruling on 'Plan B' Pill
SCOTT SIMON, host:
This is WEEKEND EDITION from NPR News. I'm Scott Simon.
Coming up, we pay another visit to the homeless diabetic that we first met last year.
But first, the Food and Drug Administration has put off deciding whether to allow over-the-counter sales of a prescription drug called Plan B, which can prevent pregnancy when taken 72 hours or less after intercourse. Earlier delays on the drug had held up the confirmation of the FDA commissioner until senators were promised a decision would be made. Now it seems it will take a little longer. NPR's Joanne Silberner has the latest.
JOANNE SILBERNER reporting:
Emergency contraception has been one of the most contentious issues the FDA has dealt with in recent years. At the root of the controversy is the nature of what the drug does and how to sell it. The pill prevents ovulation and some say also fertilization and implantation. As such, some Republican congressmembers and pro-lifers say it causes a very early abortion and that its easy availability could lead to promiscuity and sexually transmitted diseases. Advocates for Plan B say making access to the pill easier could decrease the number of unwanted pregnancies and thus the number of abortions.
At one point in the approval process, the FDA questioned whether younger women could use the drug safely without the supervision of a doctor. So manufacturer Barr Laboratories proposed allowing over-the-counter sales only to women over the age of 16. Inputting off its decision, FDA Commissioner Lester Crawford said there are many complicated questions about how to use age as a criterion for over-the-counter sales and whether the FDA could enforce it.
Mr. LESTER CRAWFORD (FDA): The answers to these questions can establish very broad and far-reaching policies that could have a significant effect on the way FDA regulates many different drugs.
SILBERNER: So Crawford wants to consider whether pharmacies can figure out how old women are and only sell over-the-counter to those who are the right age. Before making a final decision on Plan B, Crawford is opening up a new 60-day period for the public to comment on the bigger question of selling differently to different age groups. And after the 60 days...
Mr. CRAWFORD: It depends on what we get. It's impossible to predict how long a regulatory process will go.
Senator PATTY MURRAY (Democrat, Washington): To me this is just part of the delay game that we've been hearing for well over two years. We were promised by Secretary Leavitt and by the FDA that they would have a decision made on this, and this is not a decision; it's a delay.
SILBERNER: Democratic Senator Patty Murray of Washington last spring was one of two senators who put a hold on Crawford's nomination to be the commissioner of the FDA specifically because as acting commissioner he hadn't made scheduled decisions on Plan B. Murray says she's outraged by the FDA's latest move.
Sen. MURRAY: It's not good for the American public, who counts on FDA to make scientific decisions, and it's especially not good for women who are counting on their ability to have safe and effective treatments.
SILBERNER: Murray has asked for a Senate hearing soon on the issue. Joanne Silberner, NPR News, Washington.