WASHINGTON - Providing women with easy access to the emergency contraceptive Plan B did not lead them to engage in more risky sexual behavior, a study of more than 2,000 young California women has concluded.
The study did find that women given a supply to keep at home were almost twice as likely to use the drug after unprotected sex as those who had to pick it up at a clinic or pharmacy. The findings led the study authors to conclude that easy access to Plan B, also called the morning-after pill, could cut the number of unwanted pregnancies while posing no apparent risk to women.
The study contradicts a key claim made by opponents of easier access to Plan B at a time when the Food and Drug Administration is preparing to decide on a second application to allow nonprescription sales of the drug.
In an indication of the strong feelings on both sides, advocates of Plan B plan to sit in Friday at FDA headquarters in suburban Bethesda, Md. Some protesters have called for civil disobedience if the FDA official who rejected the first Plan B application, Steven Galson of the Center for Drug Evaluation and Research, refuses to meet with them.
The FDA turned down the initial application last May, saying there wasn't enough information on how easy access would affect the sexual behavior of teens.
"Our findings were that women don't change their sexual behavior when the drug is easily available, but rather that they're more likely to use it if access is easier," said lead author Tina Raine of the Center for Reproductive Health Research and Policy of the University of California, San Francisco.
The study looked at 2,117 San Francisco-area women ages 15 to 24 who were randomly put into one of three groups. One third were given the drug to take home, one third were told it could be picked up without a prescription at a clinic, and the final third could get it without a prescription at a pharmacy.
The study found that roughly the same percentage of each group had unprotected sex over a six-month period, that incidence of sexually transmitted disease was equal, and that about the same percentage became pregnant.
Nonetheless, about 37 percent of women in the group given Plan B to take home used it at least once during the six months, compared with 21 percent in the clinic-access group and 24 percent in the pharmacy-access group.
The FDA's initial decision to reject nonprescription sales touched off sharp criticism - from FDA's staff and members of its expert advisory panel, among others - that the agency was bowing to political pressure from social conservatives. In a letter to President Bush, 49 members of Congress asked that the application be rejected.
The medical profession does not consider emergency contraception to be an abortion pill like RU-486, or Mifeprex, because Plan B works by preventing a pregnancy from starting rather than ending an existing one. But some critics of Plan B consider it an abortifacient.
The new study, being published today in the Journal of the American Medical Association, supports the position taken by much of the FDA review staff and 23 of 27 members of the FDA advisory panel that the drug could be safely and properly used without a prescription.