Health
Plans change for Plan B
NEWS IN BRIEF — Posted May 24, 2004
The Food and Drug Administration on May 6 rejected a proposal for over-the-counter sales of the emergency contraceptive known as Plan B despite the approval of two agency advisory panels earlier this year.
The FDA said that the manufacturer must either find a way to prevent girls younger than 16 from purchasing the drug without a prescription, or prove, in a study, that Plan B can be safely used by girls under age 16 without a physician's supervision.
Bruce L. Downey, chair and CEO of Plan B manufacturer, Barr Pharmaceuticals Inc., indicated that the firm plans to continue to work with the FDA and that the conditions set out by the agency would not prove insurmountable barriers to OTC sales.
"In the meantime, we remain committed to providing Plan B as a prescription-only product and to increasing awareness among the health care provider community and women of this safe and effective option," Downey said.
Plan B, or levonorgestrel, is a progestin-only pill that has been shown to reduce the risk of pregnancy if taken soon after unprotected sex.
The AMA, the American Academy of Family Physicians, the American College of Obstetricians and Gynecologists and the American Academy of Pediatrics support OTC availability.
Following the rejection, charges were quickly made that politics rather than science influenced the agency's decision. A spokesman for presumed Democratic presidential candidate John Kerry blamed the White House for putting its own political interests ahead of sound medical policies. Meanwhile, conservative groups hailed the decision as a responsible one that demonstrated concern for women's health.
Note: This item originally appeared at http://www.ama-assn.org/amednews/2004/05/24/hlbf0524.htm.
