On Tuesday, April 30, 2013, the US Food and Drug Administration (FDA) announced the approval of the contraceptive known as Plan B or also popularly known as the “morning after pill” for all women aged 15 and older.
The FDA said it was responding to an application, long under review, from the maker of Plan B One-Step, Teva Women’s Health, based in North Wales, Montgomery County which asked for an over-the-counter access of this medication for women of all ages. When the FDA refused to agree to the request in December 2011, the company amended the request, adding the age threshold of 15.
Plan B One-Step® is just one brand of emergency birth control that uses the synthetic hormone levonorgestrel to prevent pregnancy after known or suspected contraceptive failure or unprotected intercourse by blocking ovulation and impeding the mobility of sperm. The manufacturers claim that it does not cause an abortion in women who are already pregnant, nor does it harm a developing fetus.
In a statement, the FDA said the approval of Plan B One-Step for use without a prescription by women 15 years of age and older is based on an actual use study and label comprehension data submitted by Teva which shows that women aged 15 and older understood that Plan B One-Step was not for routine use and would not protect them against sexually-transmitted diseases.
For more than a decade, reproductive rights groups have urged the FDA to make the drug available to all consumers without a prescription. As a result of litigation, U.S. District Judge Edward Korman of New York ordered that all levonorgestrel-based emergency birth control drugs be made available over the counter to all consumers by Monday, May 6, 2013. Some advocates of contraceptives said the FDA action was promising.
On May 1, 2013, the Department of Justice announced that it was seeking to overturn Korman’s order in the U.S. 2nd Circuit Court of Appeals. U.S. attorneys have also asked that the judge’s order be stayed, pending resolution of the appeal.
While critics argue that easy access to the drug would encourage sexual activity and promote the spread of sexually transmitted infections, Nita Chaudhary, of the organization Ultraviolet said: “While President Obama has been a champion for women, he is behind the curve when it comes to Plan B … We need him to catch up. Plan B should be available over-the-counter to women of all ages. It’s the right thing to do.”
Women’s rights advocates said the FDA announcement requires girls and women to show ID at the cash register; if not sale would be denied to them.
Now, the question is: “where will a 15-year-old get a valid ID to purchase ‘Plan B One-Step’ over the counter?”
- FDA rule on morning-after pill draws strong reaction (miamiherald.com)
- FDA approves Plan B for girls 15 and older (vitals.nbcnews.com)
- Justice Department appeals morning-after pill ruling (cnn.com)
- FDA Approves Morning-After Pill without Prescription for Girls 15 and Older (fox40.com)