Compromise may restrict contraceptive

By Marc Kaufman
The Washington Post

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Although a Food and Drug Administration (FDA) advisory panel voted 23-4 in December in favor of making the drug available on drugstore shelves, the proposed compromise would ignore important elements of that recommendation, said several sources not allowed to speak on the record.

The application to give Plan B full over-the-counter status has been criticized sharply by social conservatives who say it would lead to increased teen promiscuity.

The ongoing talks have focused on possibly setting a minimum age for purchasers and keeping the drug behind drugstore counters so pharmacists would control sales. As word of the possible restrictions has spread, critics have stepped up a campaign to try to persuade the FDA to approve the application without restrictions.

In a pointed editorial published today in the New England Journal of Medicine, the editor and two members of the FDA advisory panel wrote that the agency's actions suggest its "decision-making process is being influenced by political considerations."

The FDA said it could not respond to the criticism because it's still reviewing the application.

Plan B consists of two high doses of a hormone called levonorgestrel, which has been shown to prevent pregnancy if taken within 72 hours after sex. Advocates of wider use say it would result in a decline in unwanted pregnancies and abortions.

Many conservatives contend the social and medical consequences for adolescents in particular haven't been studied sufficiently. Objections raised by 49 Republican members of Congress in February led the FDA to delay its decision by 90 days, and it since has asked the manufacturer for more information. Opponents are particularly concerned that readily available emergency contraception would lead to increased teenage sexual activity, more unprotected sex and more sexually transmitted diseases.

Advocates of making Plan B easily available, including the authors of the journal editorial, said research into teenage use of Plan B was considered by the FDA advisory panel in December and members decided overwhelmingly that there were no scientific reasons to limit its availability.

The editorial writers said demanding that purchasers prove their age and putting the medication behind the counter would "intimidate" women and discourage many from buying it.

Drugs similar to Plan B have been available in 101 other countries, some for many years, and are sold without a prescription in 33 nations.

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