
                         Roanoke Times
                 Copyright (c) 1995, Landmark Communications, Inc.

DATE: TUESDAY, November 29, 1994                   TAG: 9412070067
SECTION: NATIONAL/INTERNATIONAL                    PAGE: A3   EDITION: METRO 
SOURCE: ASSOCIATED PRESS
DATELINE: WASHINGTON                                 LENGTH: Medium

BIRTH CONTROL PILL RELABELING URGED

A coalition of medical groups petitioned the Food and Drug Administration Monday to require relabeling of six brands of oral contraceptives to tell women how to use them as ``morning after'' pills.

The groups contend the birth control pills are misbranded, a criminal violation of drug labeling laws, because women aren't told that the right dose immediately after unprotected intercourse can prevent pregnancy.

``The FDA has stood idly by as drug manufacturers routinely suppress required information about safe and effective emergency contraception,'' said Janet Benshoof, president of the Center for Reproductive Law and Policy. ``Millions of women are being hurt.''

The center filed the petition on behalf of the American Public Health Association, the American Medical Women's Association and Planned Parenthood of New York.

The petition says six oral contraceptives sold in the United States are proven effective as emergency postcoital contraception: Wyeth-Ayerst Laboratories' Ovral, Lo/Ovral, Nordette and Triphasil, and Berlex Laboratories' Levlen and Tri-Levlen.

Although they sell the pills for emergency contraception overseas, the companies haven't added this use to U.S. labels, Benshoof said.

Wyeth-Ayerst declined comment; Berlex officials said no one was available to comment.

FDA spokesman Don McLearn said the agency would study the petition but that regulations require manufacturers to initiate a change. ``Under our law, we can't simply decide that some new indication should be on a drug and then mandate it.''

That's not true, countered Benshoof. All six pills were approved as blanket contraceptives - meaning emergency contraception is included - and labeling laws require that every benefit, side effect and dosage be labeled, she said.

by CNB