BY J. MICHAEL BRODIE
Plan B® -- the emergency contraception pill, or "morning after" pill -- should be available over the counter, two FDA panels advised the FDA recently. The Academy also weighed in on the issue.
The FDA Nonprescription
Drugs Advisory Committee and Reproductive Health Drugs Advisory Committee
voted 23 to 4 for the OTC status Dec. 16.
On the same day, AAFP Board Chair James Martin, M.D., of San Antonio wrote one of the panels to concur with the advisers' vote.
"The AAFP supports the change to OTC status because of emergency contraception's reported long-term safety record, its ease of use for our patients, the time-sensitive element of therapy and increased access to the medication for the uninsured in this country," Martin wrote.
Plan B consists of two progesterone pills to be taken 12 hours apart. For maximum effectiveness, Plan B should be taken within 24 hours after intercourse.
An FDA public affairs officer said Dec. 19 that the advisers had conducted several votes. For example, they voted 28 to 0 that there was evidence Plan B would be safe.
The 2003 AAFP Congress of Delegates voted for the OTC status for progesterone-only emergency contraceptives and recommended that information on safe sexual practices, birth control options and the advantage of having a personal physician should be included with such OTC products.
Wanda Filer, M.D., of York, Pa., was among the delegates who spoke in favor of the measure. "Emergency contraception has been underutilized, especially for sexual assault victims, even in emergency department settings," Filer, president of the Pennsylvania AFP, said last month. "The awareness of emergency contraceptives as an option to physicians and our patients has been very low."
The possible move to OTC status, accompanied by a strong educational component, could be a strong benefit to patients when time is of the essence, said Filer. "It will be vital for family physicians to be familiar with emergency contraceptives and to know how to counsel their patients about the many issues likely to surround its usage."
To reach writer J. Michael Brodie, e-mail mbrodie@aafp.org.
FP Report is published by the
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Copyright © 2004 by
American Academy of Family Physicians.