Two advisory committees to the Food and Drug Administration yesterday recommended the agency approve the “morning after” pill for sale over the counter.
The vote was 23-4 in favor of easing access to the drug.
The FDA advisory committees met yesterday to consider allowing over-the-counter sales of the pill, known as Plan B because it is used when traditional birth control is not. Women’s Capitol Corp., the pill’s manufacturer, requested the proposed change.
Women’s and pro-life organizations testified in opposition to the proposal. Concerned Women for America Senior Policy Director Wendy Wright offered a list of reasons for advising against the proposed change and referred to “the unprecedented and unsubstantiated action by the FDA in 1997 originally to approve the use of the morning-after pill (with a prescription).”
Concerned Women for America is the nation’s largest public-policy women’s organization, representing over a half-million members. Wright’s testimony included results of studies showing that “easy access to the ‘morning after’ pill has led to an increase in sexually transmitted diseases, no reduction in abortion rates, and repeat use.”
Carole Denner, R.N., of Concerned Women for America of Virginia told the advisers, “The maximum safe dose for levomorgestrel (the active ingredient in Plan B) has not been determined by scientific study.”
She added, “The health risks for those who would use Plan B (ranging in age from puberty, about age 12, to women in their 40s) are unknown.”
Jill Stanek, R.N., of Concerned Women for America of Illinois testified that one pill “contains amounts of estrogen and/or progesterone 10 to 15 times higher than a single day’s dose of the birth-control pill, with instructions to take this pill twice in 12 hours.”
She also referred to the death of a 16-year-old possibly linked to the use of the pills, according to a coroner’s report.
Colleen Parro, executive director of the pro-life organization Republican National Coalition for Life, issued a statement prior to the hearings, saying, “The so-called ‘morning-after’ or ’emergency contraceptive’ drug should not have been approved by the FDA in the first place.”
Parro emphasized that if the pill is taken after conception has occurred, an abortion will be induced, and said the proposed change “is likely to lead to some very serious health consequences for the mothers as well as for their babies, who will certainly die.”
The activist also highlighted legislation being proposed in Congress directing the General Accounting Office to “investigate the process through which the FDA approved RU-486” and report “whether the drug was approved under the requirements of the law which governs the FDA.”
Some consider concerns about the FDA’s approval processes for both Plan B and RU-486 to be part of a larger failure of the FDA to prevent dangerous drugs from harming citizens. Freelance writer and commentator Bob Pratt writes that during the “last 10 years, nine FDA approved drugs proved to have deadly side effects. … The AMA says approximately 125,000 Americans die each year from side effects of FDA approved drugs.”
The FDA usually follows the advice of its committees. If given final approval, sale of the drug over the counter could begin as soon as the spring.