FDA Allows Over-the-Counter Morning-After Pill for 17-year-olds
Posted: Thursday, June 25th, 2009 at 1:41 pm
WASHINGTON—The “morning-after pill,” which was once offered over-the-counter only to those women who were 18 and older, is now available to 17-year-olds.
A federal court ordered on March 23 that the Plan B emergency contraception pill be made available to those 17 and older.
Previously, the pill was available those younger than 18 with a prescription, but can now be purchased over-the-counter.
The United States District Judge Edward Korman also asked for consideration to make the pill available without a prescription to all women, regardless of age, saying that the expertise involved with making this decision should be left up to the FDA, who has more knowledge concerning the pill.
Korman also reprimanded the FDA for not staying true to its own procedures on the pill’s over-the-counter status, pointing out the “unusual involvement of the White House in the Plan B decision-making process.”
The judge wrote that the plaintiffs in the case presented “unrebutted evidence of the FDA’s lack of good faith” toward making Plan B over-the-counter instead of a prescription drug.
“This lack of good faith is evidenced by, among other things, (1) repeated and unreasonable delays, pressure emanating from the White House, and the obvious connection between the confirmation process of two FDA commissioners and the timing of the FDA’s decisions; and (2) significant departures from the FDA’s normal procedures and policies … as compared to the review of other switch applications in the past 10 years,” Korman wrote.
Plan B was once a prescription drug for all who requested, but in August of 2006, the FDA approved the sale without a prescription to those 18 and older.
The agency said in Wednesday’s statement, “in accordance with the court’s order, and consistent with the scientific findings since 2005 by the Center for Drug Evaluation and Research, the FDA sent a letter to the manufacturer of Plan B that the company may, upon submission and approval of an appropriate application, market Plan B without a prescription to women 17 years of age and older.”
Those opposed equate Plan B to an abortion. Others concerns are about health issues.
“Plan B is a high dose of birth control pills. … The FDA violated its standards when it made the high-dose Plan B available nonprescription to adults. But now the FDA is making the drug available to minors without parental consent,” the Concerned Women for America, a Washington-based conservative Christian group, said Wednesday.
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