Among its other duties, the U.S. Food and Drug Administration (FDA) now seems intent on regulating the sexual morality of American women.
Barr Pharmaceuticals wants to offer its emergency contraceptive levonorgestrel, marketed as Plan B, over the counter rather than by prescription. In January the FDA delayed an anticipated decision on the issue indefinitely, adding another chapter to a long and heavily politicized debate.
Taken within 72 hours after unprotected sex, Plan B reduces the average risk of pregnancy among users by 89 percent. Finding that Plan B was safe and effective at preventing unplanned pregnancies, the FDA's expert panel voted 23 to 4 in late 2003 to recommend allowing over-the-counter sales.
In January 2004 Rep. David Weldon (R-Fla.) sent a letter to President Bush, signed by 49 Republican members of Congress, opposing over-the-counter sales of Plan B, on the assumption that its availability would increase promiscuity and venereal disease. The letter was part of a larger campaign to cloud a medical issue with moral concerns. So far, it has worked.
The FDA is supposed to approve drugs that are safe and effective. Plan B clearly is both. Nevertheless, on May 6, 2004, the FDA rejected the advice of its scientific advisory board on the dubious grounds that there hasn't been enough testing with adolescent females.
Now Barr Pharmaceuticals has to jump through yet more hoops to get Plan B approved for sale without a prescription. The company has proposed an arrangement in which Plan B would be available to women over age 16 without a prescription but from behind the pharmacist's counter. Even this compromise isn't possible until the FDA makes a decision, which the agency has so far been unwilling to do.