May 1, 2013 — FDA on Tuesday approved over-the-counter sales of the emergency contraceptive Plan B One-Step to people ages 15 and older with proof of age, the New York Times reports. The decision lowers the age limit from 17 and lifts a requirement that the drug be kept behind the counter.
FDA said the decision was made in response to an amended application submitted by the drug's manufacturer, Teva Pharmaceuticals, and not in reaction to last month's ruling by a federal judge ordering that EC be made available without age or point-of-sale restrictions. The agency and White House officials said the Department of Justice is still deciding whether to file an appeal in the case (Belluck, New York Times, 4/30). DOJ has until May 5 to take action (Kliff/Goldfarb, Washington Post, 4/30).
FDA Commissioner Margaret Hamburg said in a statement, "Research has shown that access to [EC] products has the potential to further decrease the rate of unintended pregnancies in the United States." She added, "The data reviewed by the agency demonstrated that women 15 years of age and older were able to understand how Plan B One-Step works, how to use it properly and that it does not prevent the transmission of sexually transmitted disease."
Changes to Packaging
According to FDA, the label for Plan B One-Step will now state, "Not for sale to those under 15 years of age. Proof of age required. Not for sale where age cannot be verified" (Morin, "Science Now," Los Angeles Times, 4/30).
FDA's decision does not apply to generic, two-dose versions of EC because there are not enough data demonstrating that younger adolescents can use those products responsibly without a physician's supervision, according to FDA spokesperson Erica Jefferson (New York Times, 4/30).
The new packaging for Plan B One-Step will include a bar code that will prompt the cashier to request ID and verify the customer's age. In addition, an anti-theft security tag will be placed on the package ("Science Now," Los Angeles Times, 4/30).
The AP/Boston Globe notes that most states issue driver's licenses -- the most common form of identification -- at age 16. A birth certificate or passport also could be used as proof of age.
Teva said it expects to begin OTC sales in a few months (Neergaard, AP/Boston Globe, 4/30).
Mixed Reaction From Advocates
Women's health advocates said the changes are an improvement but continued to call for removing the age restrictions entirely. Observers also expressed some confusion about what the announcement means for the prospect of an appeal by DOJ in the court case.
Cecile Richards -- president of Planned Parenthood Federation of America -- in a statement called FDA's announcement "an important step forward to expand access to [EC] and for preventing unintended pregnancy." She noted that Planned Parenthood continues "to believe that the administration should lift all unnecessary restrictions to [EC]."
Judy Waxman -- vice president of the National Women's Law Center -- said the decision "triggers [the administration's] intention to file an appeal even if they haven't yet," noting that it "doesn't comply with the judge's ruling" (Washington Post, 4/30).
The Center for Reproductive Rights -- which filed the lawsuit that resulted in the judge's order -- said on Tuesday FDA continues to ignore the barriers that age requirements create for women seeking EC.
CRR President Nancy Northup in a statement said, "Lowering the age restriction to 15 for over-the-counter access to Plan B One-Step may reduce delays for some young women -- but it does nothing to address the significant barriers that far too many women of all ages will still find if they arrive at the drugstore without identification" ("Science Now," Los Angeles Times, 4/30).
Northup said CRR "will continue [its] battle in court to remove these arbitrary restrictions on [EC] for all women" (New York Times, 4/30).
Meanwhile, conservative groups criticized FDA's decision. Susan B. Anthony List President Marjorie Dannenfelser said the agency "is recklessly positioning itself as a parent to our children," adding, "Fifteen year old girls need the protection that comes with the involvement of real parents and doctors in their lives" (Washington Post, 4/30).